Generics Industry News Search
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September 2007 News Archive |
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/Genetic Engineering & Biotech News/ Sep 1 2007 (Vol. 27, No. 15) -- Lessons to Be Learned from the Dispute over Chinese Patent Related to Viagra: China’s progress on the road to intellectual property rights is exemplified in pharmaceutical protection. This article describes a variety of laws and regulations that can be effectively used to protect pharmaceutical products in China. Click here to read full article (www.genengnews.com)...
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/Patent Docs Blog/ September 03, 2007, By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring....
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CORONA, Calif., September 04, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received its first U.S. Food and Drug Administration (FDA) product approval at its Goa, India facility. During the next several months the company plans to seek FDA approval to manufacture additional solid dosage products at the facility. By early 2008, the Goa facility is expected to be producing over 1 billion tablets and capsules annually for the U.S. market....
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/Orange Book Blog/ September 04, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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WALTHAM, Mass., September 05, 2007 /PRNewswire/ -- Decision Resources, Inc., one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Amgen, the leading manufacturer of biologic agents with biologic sales of more than $14 billion in 2006, and Genentech, the second leading biologics manufacturer with biologic sales of more than $9 billion in 2006, are bracing themselves for heavy pressure from biogeneric manufacturers....
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NEW YORK, September 05, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and H. Lundbeck A/S of Denmark said today that the U.S. Court of Appeals for the Federal Circuit has affirmed a July 13, 2006 decision by the U.S. District Court for the District of Delaware which determined that the U.S. patent covering escitalopram, the active ingredient in Lexapro(R), is valid and upheld the injunction preventing Ivax/Teva's proposed generic product launch, thereby confirming Forest's and Lundbeck's patent rights for Lexapro(R), which expire in March 2012....
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JERUSALEM, Israel--(BUSINESS WIRE)--Sep 5, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that further to its press release dated August 24, 2007, the U.S. District Court for the District of New Jersey has denied a motion filed by Novartis for a preliminary injunction related to Teva's Famciclovir Tablets, AB-rated to Novartis' Famvir(R)....
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MORRISTOWN, N.J., September 05, 2007 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Carvedilol tablets in the U.S.. Distribution of the product will commence immediately....
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DETROIT, September 05, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg (Carvedilol)....
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ROCKVILLE, Md., Sept. 5, 2007-The U.S. Food and Drug Administration today approved the first generic versions of Coreg (carvedilol). Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack....
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/Orange Book Blog/ Sept 05, 2007 -- In an opinion released today, the Court of Appeals for the Federal Circuit affirmed a district court decision that upheld the validity of Forest Labs' U.S. Reissue Patent 34,712, which covers (+)-citalopram, the active ingredient in Lexapro. Teva, seeking to market a generic version of Lexapro before the '712 patent expires in 2012, challenged the patent's validity in a paragraph IV filing....
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/Patent Docs Blog/ September 05, 2007 -- The Federal Circuit today affirmed a District Court finding that ANDA filer Ivax Pharmaceuticals and co-Defendant Cipla had not shown by clear and convincing evidence that Forest Laboratories' patent-in-suit for Lexapro® was invalid. In doing so, the CAFC answered (for now) the question of whether a patent on a particular, biologically-active enantiomer of a patented drug is obvious....
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/Patently-O Blog/ Sep 05, 2007 -- (J.Lourie) IVAX’s infringement began when it filed an abbreviated new drug application (ANDA) with the FDA for approval to manufacture a generic version of Forest Lab’s blockbuster antidepressant Lexapro. Under 35 USC 271(e)(2), the mere submission of the ANDA is considered an “act of infringement.”...
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/Patently-O Blog/ Sep 05, 2007 -- The Court of Appeals for the Federal Circuit today upheld Forest Labs patent on its billion dollar SSRI Lexapro (escitalopram oxalate) — rejecting IVAX’s arguments that the patent is anticipated and obvious. Based on two FDA extensions, the patent is set to expire on March 14, 2012....
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JERUSALEM--(BUSINESS WIRE)--Sep 6, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its Generic version of GlaxoSmithKline's cardiovascular agent Coreg(R) (Carvedilol) Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg. Shipment of this product will begin immediately....
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PITTSBURGH, September 06, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg....
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HAWTHORNE, N.Y.--(BUSINESS WIRE)--Sep 6, 2007 - Acorda Therapeutics, Inc. (NASDAQ: ACOR) announced today that it has received a Paragraph IV Certification Notice from Apotex Inc. advising that it has filed an Abbreviated New Drug Application (ANDA) for generic versions of the three Zanaflex Capsules(TM) (tizanidine hydrochloride) dosage strengths....
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PRINCETON, N.J., September 06, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg, a beta blocker used to treat heart failure....
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MT. LAUREL, N.J.--(BUSINESS WIRE)--Sep 6, 2007 - AmeriHealth is offering area doctors a way to dispense free samples of generic drugs in a move to encourage generic drug use and keep down the cost of prescription drugs. Patients receive generic samples for one course of treatment, usually a 30-day supply....
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WASHINGTON, September 06, 2007 /PRNewswire-FirstCall/ -- Expensive biologic medicines are arriving at a critical crossroads as decades-old patents expire, and generic companies stand ready to add biogenerics to the industry's portfolio. Now is the time to pass legislation enabling the U.S. Food and Drug Administration (FDA) to create an abbreviated regulatory pathway for safe, pure and effective biogenerics, Hospira CEO and Chairman Christopher Begley said today...
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MADISON, N.J., September 06, 2007 /PRNewswire-FirstCall/ -- Wyeth , and its business partner Nycomed GmbH, announced today that the United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for a preliminary injunction against Teva Pharmaceuticals USA, Inc. and Sun Pharmaceuticals Inc. seeking to prevent the launch of a generic version of PROTONIX(R) (pantoprazole sodium) prior to resolution of ongoing patent litigation between the parties....
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/Patent Baristas Blog/ September 6th, 2007 -- The Federal Circuit upheld a judgment upholding the validity of U.S. Reissue Pat. No. 34,712 in favor of Forest Laboratories and H. Lundbeck A/S and enjoining Ivax Pharmaceuticals and Cipla Ltd. from infringing the ’712 patent — but only as it applies to escitalopram oxalate....
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MORRISTOWN, N.J., September 07, 2007 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received final approval of amlodipine besylate tablets from the U.S. Food & Drug Administration. Distribution of the product will commence immediately....
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JERUSALEM--(BUSINESS WIRE)--Sep 7, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that further to its press release dated September 5, 2007, it has commenced shipment of Famciclovir Tablets, 125 mg, 250 mg and 500 mg, AB-rated to Novartis' herpes treatment Famvir(R) Tablets. As the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity....
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JERUSALEM-- (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that further to its press release dated September 7, 2007, it has received notice that the United States Court of Appeals for the Federal Circuit has issued an order temporarily enjoining the Company from further sales of generic Famciclovir Tablets, AB-rated to Novartis’ Famvir® Tablets....
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Friday, September 07, 2007 -- WASHINGTON -- The generic-drug industry is experiencing rapid growth, easily outpacing the big brand-name companies, according to an analysis by market research firm IMS Health. "The wind is at the back of the generic industry," Doug Long, a vice president of IMS Health, said yesterday at a meeting of the Generic Pharmaceutical Association here. Click here to read full article (www.nj.com)...
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/Orange Book Blog/ Sept 09, 2007 -- Last Thursday, a federal district court denied Wyeth’s motion for a preliminary injunction that would have prevented generic drug manufacturer Teva from launching its generic version of Protonix. The opinion denying Wyeth's motion was filed under seal; only the order is publicly available currently....
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By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week: Sepracor v. Sun (desloratidine)...
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PITTSBURGH, September 10, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules, 15 mg and 25 mg....
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BRISTOL, Tenn.--(BUSINESS WIRE)--Sep 10, 2007 - King Pharmaceuticals, Inc. (NYSE: KG) reported today that the Company has learned that Actavis, a manufacturer of generic pharmaceutical products headquartered in Iceland, has filed a Paragraph IV Certification with the U.S. Food and Drug Administration ("FDA") pertaining to King's product, AVINZA(R) (morphine sulfate extended release)....
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BASEL, Switzerland, September 10, 2007 - A US federal appeals court has approved a request by Novartis and temporarily prohibited Teva Pharmaceuticals from selling its generic version of the antiviral medicine Famvir®, which has various US patents valid until 2015....
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SCHAUMBURG, Ill.--(BUSINESS WIRE)--Sep 11, 2007 - Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL vials, USP, the generic equivalent of Hoffmann-La Roche's Kytril(R) Injection...
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MUMBAI, India, September 11, 2007- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Wyeth's Protonix ®, pantoprazole tablets....
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/Orange Book Blog/ Sept 11, 2007 -- The Court of Appeals for the Federal Circuit today reversed a district court trial verdict that held the asserted claims of Aventis's patent on Altace not invalid, finding instead that the claimed invention would have been obvious. The patent in suit was U.S. Patent No. 5,061,722, which covers ramipril, the active ingredient in Altace....
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/FiercePharma/ September 11, 2007 -- ... Roche is suing Teva for producing a generic version of its osteoporosis treatment Boniva, whose patents begin to expire in 2012....
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/Patently-O Blog/ Sep 11, 2007 -- Altace is the King/Aventis brand of ramipril – a top-selling ACE inhibitor. The patent claims ramipril formulated “substantially free of other isomers.” The district court found the patent not invalid, but only by a slim margin. On appeal the CAFC reversed – finding the patent invalid as obvious....
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LEXINGTON, Mass.--(BUSINESS WIRE)--Sep 12, 2007 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that due to a technical error, one of the CUBICIN(R) (daptomycin for injection) patents listed in the Orange Book (U.S. Patent No. RE39071, originally issued to Eli Lilly, and now owned by Cubist) should be corrected. The Company identified this error as part of its preparations for a potential Paragraph IV filing against its lead product, CUBICIN....
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NEW YORK--(BUSINESS WIRE)--Sep 12, 2007 - Pfizer Inc said today that the Canadian Federal Court in Toronto has ruled that Pfizer's patent covering a crystalline form of atorvastatin, the active ingredient in Lipitor, would be infringed by Ranbaxy Laboratories Limited's process for making their proposed generic atorvastatin product....
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/Patent Docs Blog/ Sept 12, 2007 -- The contours of the Federal Circuit's obviousness jurisprudence post-KSR continued to be revealed today with the CAFC's decision in Aventis Pharma Deutschland GmbH v. Lupin, Ltd.
... The case involves Lupin's filing of an Abbreviated New Drug Application (ANDA) for a generic version of the blood pressure medication ramipril...
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SAN DIEGO-- (BUSINESS WIRE) -- Santarus, Inc. (Nasdaq:SNTS), a specialty pharmaceutical company, today announced that it has filed a lawsuit in the United States District Court for the District of Delaware against Par Pharmaceutical, Inc. for infringement of the patents listed in the Orange Book for ZEGERID® (omeprazole/sodium bicarbonate) Capsules. The University of Missouri, licensor of the patents, is joined in the litigation as a co-plaintiff....
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ESPOO, Finland, Sept. 13, 2007--Orion Corporation has filed a patent infringement lawsuit in the United States to enforce U.S. Patent No. 5,446,194 and U.S. Patent No. 5,135,950 against generic drug companies Wockhardt USA, Inc. and Wockhardt Limited, who seek to market generic entacapone (200 mg tablets) in the United States....
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/Patent Docs Blog/ Sept 13, 2007 -- On Tuesday, Teva Pharmaceuticals and Dr. Reddy's Laboratories filed a joint stipulation of dismissal in their pending lawsuit over generic sertraline hydrochloride (the API in Pfizer's Zoloft®, used to treat depression)....
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/FiercePharma/ September 13, 2007 -- When does good news feel almost bad? When a blockbuster drug is deemed the juiciest on the market--but the wolves are circling. If this sounds like Lipitor to you, you're right. Today, the Pfizer drug was declared number one in the U.S. market with $9 billion in 2004 sales (rival Zocor pulled a trailing second with $4.7 billion).
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/Orange Book Blog/ Sept 14, 2007 -- Novartis and Teva have been in litigation over Teva's ANDA for generic Famvir (famciclovir), Novartis's antiviral treatment for herpes, since 2005. Teva was prepared to launch its generic famciclovir product on August 24, 2007--the day the 30-month stay expired. To prevent such an at-risk launch, Novartis filed a motion for a preliminary injunction, claiming that Teva infringes U.S. Patent No. 5,246,937....
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/FiercePharma/ September 14, 2007 -- Indian generics maker Ranbaxy Laboratories says it's set to plunk down more than half a million dollars on new healthcare facilities in the Punjab area of India, including hospitals and medical institutes....
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IRVINE, Calif., Sept. 14, 2007 – Teva Health Systems is pleased to announce the introduction and availability of Fosphenytoin Sodium Injection, USP. This product is AP rated to Cerebyx®* Injection. Fosphenytoin Sodium Injection is available in 50 mg PE/mL, 100 mg PE and 50 mg PE/mL, 500 mg PE strengths, in 2 mL and 10 mL single dose vials, respectively....
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/Orange Book Blog/ September 16, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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/Patent Docs Blog/ September 16, 2007 By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring....
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MORRISTOWN, N.J., September 17, 2007 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today confirmed that Actavis Elizabeth L.L.C. has initiated a challenge of the patent listed in connection with King Pharmaceuticals' Avinza(R) (morphine sulfate extended-release capsules). Actavis believes that it is the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avinza....
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/Times News Network/ 17 Sep, 2007, MUMBAI: One of the world’s hottest battlefields is the generic drugs market in the United States, where drugs worth $35-40 billion are set to lose patent protection by 2010-11. Having emerged as a gold mine for Indian pharmaceutical companies in recent years, the market is now reeling under pricing pressure and competition. ... However, the rules of the game are changing: generic and innovator companies are adopting increasingly aggressive strategies to gain or protect turf in the market. Click here to read full article (economictimes.indiatimes.com)...
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/FiercePharma/ September 18, 2007 -- At least three Indian drug makers were spotted with chocolate and flowers at the headquarters of Par Pharmaceuticals, one of the top 10 generics companies in the U.S. Several Indian newspapers are reporting today that Ranbaxy Laboratories, Wockhardt, and Sun Pharma are all three courting the company. The three would-be suitors declined comment....
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/Orange Book Blog/ September 18, 2007 -- Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), spent some quality time this afternoon answering questions from bloggers about follow-on biologics, patent reform, and FDARA/PDUFA legislation. Mr. Greenwood said that follow-on biologics are a "critical, critical issue" for BIO....
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/Patent Baristas Blog/ September 18th, 2007 -- Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO) gave a briefing to biotech & pharma bloggers on key issues related to follow-on biologics, patent reform and PDUFA pending legislation. In the conference call, Greenwood provided an overview of the biggest issues for BIO and then fielded questions from the participants....
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/Patent Docs Blog/ September 18, 2007 -- on August 9, Eli Lilly filed suit in the District Court of New Jersey against Actavis Elizabeth in answer to Actavis' filing of an ANDA (and concomitant Paragraph IV certification) to manufacture a generic version of Lilly's Strattera®. Earlier this month, Lilly filed an amended complaint in the case, adding additional ANDA/Paragraph IV filers...
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AMITYVILLE, N.Y.--(BUSINESS WIRE)--Sep 19, 2007 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Ciclopirox topical solution, 8%. Hi-Tech's Ciclopirox topical solution is the generic equivalent of Dermik Laboratories' nail fungus treatment Penlac(R)
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DUBLIN, Ohio, September 19, 2007 /PRNewswire-FirstCall/ -- Alliance Boots and Cardinal Health today announced a sourcing and marketing agreement for the sale of Almus generic prescription medicines. Cardinal Health is a global provider of products and services that improve the safety and productivity of health care. Alliance Boots is an international, pharmacy-led health and beauty group.
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NEWTOWN, Pa.--(BUSINESS WIRE)--Sep 19, 2007 - Synerx Pharma, LLC announced today that it has received final U.S. Food and Drug Administration (FDA) approval for the Company's Abbreviated New Drug Application (ANDA) for Ciclopirox topical solution, 8%. Synerx's product is a generic equivalent of Dermik Laboratories' prescription product Penlac(R), a topical ciclopirox treatment for nail fungus. ...
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/Patent Infringement Updates Blog/ September 19, 2007 -- Kevin McDonald and John Mauk of Jones Day wrote an article titled, "Reverse Payments in Hatch-Waxman Cases and the Continuing Antitrust-Patent Battle." They write: "Contrary to popular myth, branded and generic pharmaceutical companies do not disagree about everything....
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HAWTHORNE, N.Y.-- (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (“Taro,” Pink Sheets: TAROF) reported today that it has received approvals from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for Ciclopirox Topical Solution, 8% (Nail Lacquer) (“ciclopirox nail lacquer”) and its Supplemental ANDA for Loratadine Syrup (Oral Suspension), 5 mg/5 mL (“loratadine syrup”) in a grape flavored formulation, an over-the-counter (OTC) product....
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/Orange Book Blog/ September 20, 2007 -- Apotex suffered a loss last week in its effort to relitigate the validity of U.S. Patent No. 5,110,493, which covers Roche's ketorolac tromethamine (KT) ophthalmic solution (i.e., Acular®)....
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JERUSALEM-- (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the United States Court of Appeals for the Federal Circuit has reversed and remanded an August 2005 summary judgment decision by the U.S. District Court for the District of New Jersey with regards to Pfizer Inc.'s U.S. Patent No. 6,054,482....
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NAPA, Calif., Sept. 21 /PRNewswire/ -- Dey, L.P. announced that the United States District Court of New York has issued a Scheduling Order setting December 12, 2008 as the trial date for the Company's intellectual property infringement suit against Sepracor for Brovana(TM) (arformoterol tartrate) Inhalation Solution....
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/Orange Book Blog/ September 21, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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/Associated Press/ September 21, 2007 WASHINGTON - The bill Congress is soon expected to pass giving regulators more authority over pharmaceutical companies is most significant to biotech drug makers and their would-be generic rivals because of what was left out. Generic drug makers such as Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals failed to persuade lawmakers to attach legislation that would allow them to market generic versions of biotech drugs produced by the likes of Amgen Inc. and Genentech Inc. Click here to read full article (www.boston.com)...
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/Generic Pharmaceuticals & IP Blog/ by Sandeep K. Rathod - September 22, 2007 -- Recent updates in litigation concerning Pantoprazole, Gabapentin and Valsartan...
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/Orange Book Blog/ September 23, 2007 -- Last Friday, the Court of Appeals for the Federal Circuit reversed a 2005 district court ruling granting summary judgment of noninfringement to several companies who sought to market generic versions of Pfizer's epilepsy drug Neurontin (gabapentin). The district court had ruled on summary judgment that generic versions of Neurontin made by Teva, IVAX, and Eon did not infringe Pfizer's U.S. Patent No. 6,054,482, which covers a process for the preparation of, and compositions containing, gabapentin....
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/Patent Docs Blog/ Upcoming conferences of note....
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LEXINGTON, Mass.--(BUSINESS WIRE)--Sep 24, 2007 - A study published in the current edition of Clinical Pharmacokinetics, a peer-reviewed scientific journal, reports that two different combinations of individual isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD), used in the Vasodilator-Heart Failure Trials (V-HeFT) I and II are not bioequivalent to BiDil(R), the fixed-dose combination of ISDN and HYD, used in the African American Heart Failure Trial (A-HeFT)....
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HAMILTON, Bermuda, September 24, 2007 /PRNewswire-FirstCall/ -- Warner Chilcott Limited announced today that its subsidiary, Warner Chilcott Company, Inc., has filed a lawsuit against Barr Laboratories, Inc. ("Barr") in the District Court for the District of New Jersey for infringement of the Company's U.S. Patent No. 6,667,050 (the "050 Patent") which covers FEMCON FE...
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/Patent Docs Blog/ September 24, 2007 By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week: Focalin, Boniva, Comtan, Zegerid & Oxycontin...
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/Business Week/ September 24, 2007 -- China is coming from behind and challenging India in an industry it has traditionally dominated. During the first week of August, drug multinational (MNC) Novartis suffered a setback in India when it lost a legal challenge to the country's patent law. After being refused a patent for Glivec, a leukemia drug, the company moved to challenge the validity of India's patent law, which does not protect incremental innovations. The company launched several lawsuits, including one that said the law went against WTO rules. Click here to read full article (www.businessweek.com)...
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WOODCLIFF LAKE, N.J., September 25, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Patent and Trademark Office (PTO) has reissued the Company's patent, U.S. Patent No. 5,898,032, for SEASONALE(R) extended-cycle oral contraceptive. The reissued patent has a new number, RE39861, and the same expiration date of June 23, 2017....
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WOODCLIFF LAKE, N.J., Sept. 25 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Sanofi- Aventis U.S. LLC in connection with its UROXATRAL(R) (alfuzosin hydrochloride extended-release tablets), 10mg....
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/Bangkok Post/ September 25, 2007 -- Thailand is considering more compulsory licences on three cancer medicines, while another key cancer drug will not be targeted after the patent holder agreed to give free access to patients under Thailand's medical healthcare scheme. Earlier, the National Health Security Office revealed it might propose that the Ministry of Public Health impose compulsory licenses, or CL, on four cancer drugs if the negotiations with drug companies for lower prices proved fruitless. The drugs that could be affected include Imanitib and Letrozole from Novartis; Docetaxel from Sanofi-Aventis; and Erlotinib from Genentech. Click here to read full article (www.bangkokpost.com)...
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/The Economic Times/ 25 Sep, 2007 MUMBAI: US drug giant Eli Lilly & Co has filed a patent infringement suit against Sun Pharmaceutical Industries to prevent the latter from selling a generic version of its hyperactivity-disorder drug Strattera in the US. Sun Pharma is seeking approval to sell a generic version of the drug, insisting that Eli Lilly’s running patent on Strattera is not valid. Click here to read full article (economictimes.indiatimes.com)...
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CORONA, Calif., September 26, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution in the 0.021% (base) and 0.042% (base) strengths...
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DETROIT, September 26, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Methimazole Tablets USP, 5 mg and 10 mg (Methimazole)....
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/Patent Baristas Blog/ September 26th, 2007 -- In an appeal from a summary judgment of noninfringement of U.S. Patent 6,054,482, the Fed Circuit concluded that the district court erred in determining that there were no genuine issues of material fact concerning whether Warner Lambert failed to meet its burden of proof that the accused products infringe the asserted claims of the ’482 patent. See: In Re Gabapentin Patent Litigation ...
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/Patent Docs Blog/ September 26, 2007 -- Late last week, Novartis and Ranbaxy filed a joint stipulation and dismissal in their pending lawsuit over generic valsartan, the active ingredient in Novartis' Diovan®, used to treat hypertension. ...
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ALLEGAN, Mich., September 27, 2007 /PRNewswire-FirstCall/ -- Perrigo Company announced today that it had filed an Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex(R)....
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JERUSALEM-- (BUSINESS WIRE) Sep 27, 2007 -- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the District Court case has been settled on terms that are confidential allowing Teva by license to enter the U.S. market with its generic versions of Avandia® (Rosiglitazone Maleate), Avandamet® (Rosiglitazone Maleate/Metformin HCl) and Avandaryl® (Rosiglitazone Maleate/Glimepiride) oral tablets late in the first quarter, 2012....
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/Patent Docs Blog/ September 27, 2007 -- Last Friday, the Federal Circuit reversed a District Court's finding on summary judgment that eight generic drug manufacturers did not infringe U.S. Patent No. 6,054,482 (the '482 patent), and affirmed the District Court's construction of two disputed claim limitations. Plaintiffs-Appellants Warner Lambert Co., Pfizer Inc., and Gödecke Aktiengesellschaft (Warner Lambert) manufacture and sell Neurontin®, which is used to treat cerebral disorders such as epilepsy and which comprises the active ingredient gabapentin. ...
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JERUSALEM--(BUSINESS WIRE)--Sep 28, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that further to its press release dated September 8, 2007, the United States Court of Appeals for the Federal Circuit has denied Novartis' emergency motion for an injunction pending its appeal of a September 5, 2007 District Court preliminary injunction ruling in favor of Teva. Teva can resume sales of its generic Famciclovir Tablets, AB-rated to Novartis' Famvir Tablets.
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NEW YORK--(BUSINESS WIRE)--Sep 28, 2007 - Pfizer Inc said today that the Canadian Federal Court in Toronto has ruled that Pfizer's second medical use patent covering Viagra would be infringed by Apotex' proposed generic product. The court granted the company's application for an order preventing Apotex from launching a generic version of Viagra until expiration of Canadian Patent No. 2,163,446 in 2014....
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/Orange Book Blog/ September 28, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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/Patent Baristas Blog/ September 28th, 2007 -- President Bush has signed the FDA Amendments Act of 2007 into law. The Senate passed the bill, H.R. 3580, by unanimous consent on Sept. 20, a day after the House approved it in a 409-17 vote. The massive 422-page FDA bill, the biggest overhaul to the FDA in the last decade, renews device and drug user fees for five years and strengthens product safety programs....
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/Patent Baristas Blog/ September 28th, 2007 -- The FDA’s Office of Generic Drugs posted a letter requesting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues. This concerns an ANDA submitted to the FDA containing a paragraph IV patent certification requesting FDA approval for a generic version of Bayer Pharmaceuticals’ PRECOSE (acarbose) Tablets....
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/Patent Docs Blog/ September 30, 2007 By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. In this week: Adams Respiratory Therapeutics v. Perrigo Company (Guaifenesin); Hoffmann-La Roche v. Orchid Chemicals (ibandronate); Sanofi-Aventis v. Actavis, Barr Laboratories (Alfuzosin); Sanofi-Aventis v. Mayne Pharma (oxaliplatin ); Hoffman-La Roche v. Cobalt Pharmaceuticals, Dr. Reddy's (Ibandronate); Eli Lilly v. Sun Pharmaceutical (atomoxetine); Warner Chilcott v. Barr (norethindrone and ethinyl estradiol)...
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