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December 2007 News Archive |
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/Patent Docs Blog/ December 02, 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: Schering v. Anchen (desloratidine); Aventis v. Wockhardt (fexofenadine); King v. Teva (ramipril)...
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TORONTO--(BUSINESS WIRE)--Dec 4, 2007 - Biovail Corporation (NYSE, TSX: BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has reached a settlement agreement with Watson Pharmaceuticals, Inc. (NYSE: WPI), with respect to patent litigation against Watson subsidiary Andrx Pharmaceuticals, Inc. related to Andrx's abbreviated new drug application for a generic version of Cardizem(R) LA, Biovail's once-daily formulation of diltiazem....
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CORONA, Calif., December 04, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Biovail Laboratories International SRL on outstanding patent litigation against Andrx Pharmaceuticals, Inc., a subsidiary of Watson, related to Andrx's generic version of Cardizem(R) LA (diltiazem extended-release tablets)....
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PITTSBURGH, December 04, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Matrix Laboratories Limited* has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate Tablets, 300 mg. Matrix's Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Inc.'s Viread Tablets, 300 mg....
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/Patent Baristas Blog/ December 4th, 2007 -- In a nonprecedential opinion, the United States Court of Appeals for the Federal Circuit held that extrinsic evidence is great when it’s being used against you, bad if you try to use it to help your patent. ... Pharmaceutical Resources and Par Pharma appealed a summary judgment of invalidity of U.S. Patent Nos. 6,593,318 and 6,593,320 for lack of enablement. The patents relate to stable flocculated suspensions of megestrol acetate and methods for making such suspensions....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Dec 5, 2007 - Akorn, Inc. (NASDAQ:AKRX) today announced that it has submitted the first Abbreviated New Drug Application (ANDA) with the Office of Generic Drugs on behalf of Serum Institute of India, Ltd. Akorn and Serum announced the signing of an exclusive drug development and distribution agreement for 16 anti-cancer injectable products in October 2004....
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DETROIT, December 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 Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine)....
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FRANKFORT, Ky., December 05, 2007 /PRNewswire-USNewswire/ -- Kentucky pharmacist press conference to discuss new Medicaid generic prescription drug reimbursement rule and the need for Sen. Mitch McConnell (R-Ky.) to use his power to make sure the legislative fix is considered before Congress adjourns for the year. The rule, scheduled to be fully implemented in early 2008, will grossly underpay pharmacists and puts patient access at risk....
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/Orange Book Blog/ December 05, 2007 -- Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva's ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a paragraph IV certification to U.S. Patent No. 4,743,450. According to Teva's 2002 approval letter, Teva also filed its ANDA with a paragraph III certification to U.S. Patent No. 4,344,949, which expired on October 3, 2002, and section viii statements to U.S. Patent Nos. 5,684,016 and 5,747,504....
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HAYWARD, Calif.--(BUSINESS WIRE)--Dec 6, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has submitted information to the U.S. Food and Drug Administration (FDA) in response to the notice of rescission related to IMPAX's Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER. ...
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MUMBAI, India, Dec. 6, 2007-Sun Pharmaceutical Industries Ltd. announced that it has executed a settlement agreement with Novartis stipulating a dismissal of the lawsuits filed in the United States against the Company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Exelon, rivastigmine tartrate capsules....
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CORONA, Calif., December 06, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively "Novartis") on outstanding patent litigation related to Watson's generic version of Exelon(R) (rivastigmine tartrate) capsules.
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/Patent Baristas Blog/ December 6th, 2007 -- In an appeal by Apotex, the Court of Appeals for the Federal Circuit affirmed a summary judgment in favor of Merck that Merck had been using a process before it was patented by Apotex. Apotex v. Merck & Co. (06-1405) ... Apotex sued Merck alleging that its process for formulating and producing tablets of the pharmaceutical compound enalapril (Vasotec) used to treat high blood pressure) infringed Apotex’s U.S. Pat. No. 5,573,780 and No. 5,690,962....
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/Orange Book Blog/ December 09, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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/Patent Docs Blog/ December 09, 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: Abbott v. Zydus (divalproex); Sepracor v. Anchen (desloratidine); Senju v. Apotex (gatifloxacin); Sun v. Eli Lilly (gemcitabine)...
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PRINCETON, N.J., December 10, 2007 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. today announced the company has settled a lawsuit against Pfizer claiming that Pfizer's product Exubera(R) infringed patents owned by Novo Nordisk. The patents cover inhaled insulin treatment for diabetes....
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/Orange Book Blog/ December 11, 2007 -- Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate). The '893 patent claims atorvastatin calcium, which is also the active ingredient in Lipitor; the '574 patent claims combinations of atorvastatin sodium and amlodipine besylate. ...
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/Patent Docs Blog/ December 11, 2007 -- Last month, the Federal Circuit affirmed a District Court's finding on summary judgment that Merck & Co., Inc. had not obtained favorable rulings in two prior proceedings by fraud. The prior proceedings included an infringement suit involving U.S. Patent Nos. 5,573,780 (the '780 patent) and 5,690,962 (the '962 patent) owned by Apotex Corp., and Apotex' appeal of that decision to the Federal Circuit....
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PITTSBURGH, December 12, 2007 /PRNewswire-FirstCall/ -- Mylan 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 Lamotrigine Tablets, 25 mg, 100 mg, 150 mg and 200 mg....
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LONDON, Dec. 12, 2007-AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™
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WASHINGTON, December 12, 2007 /PRNewswire-USNewswire/ -- According to data released by the National Consumers League today, Americans with unhealthy cholesterol levels would be more likely to consider taking an over-the-counter (OTC) statin option than a prescription (Rx) product, but the likelihood to use an OTC had decreased since 2004....
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PHILADELPHIA--(BUSINESS WIRE)--Dec 12, 2007 - Lannett Company, Inc. (Amex:LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the company's supplemental Abbreviated New Drug Application (ANDA) of Phentermine Hydrochloride Capsules 30 mg. The company expects to commence marketing this product immediately....
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PHILADELPHIA, December 12, 2007 /PRNewswire/ -- Generic prescription drug use is on the rise and more and more people are learning about the effectiveness, safety and cost saving benefits of generics, according to the results of a fall 2007 study conducted by Independence Blue Cross (IBC). Three-quarters of the IBC members surveyed believe generic drugs are as safe and effective as their brand-name equivalents....
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JERUSALEM--(BUSINESS WIRE)--Dec 12, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' antiepileptic therapy Trileptal(R) (Oxcarbazepine) Tablets, 150 mg, 300 mg and 600 mg....
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MENLO PARK, Calif.--(BUSINESS WIRE)--Dec 13, 2007 - Depomed, Inc. (Nasdaq:DEPO), today announced that Judge Charles Breyer of the United States District Court for the Northern District of California has granted Depomed's motion for summary judgment of infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 in the company's patent litigation against IVAX Corporation, and denied all three of IVAX's summary judgment motions....
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NEW YORK, December 13, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. , announced today that it has received notification from several companies that they have filed Abbreviated New Drug Applications (ANDA) with Paragraph IV Certifications to obtain approval to market generic equivalents of Namenda, an NMDA receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ...
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MONTVALE, N.J., December 14, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc. has filed suits against Watson Pharmaceuticals and against Sandoz, a subsidiary of Novartis for infringement of the patent protecting Duramed's SEASONALE(R) extended-cycle oral contraceptive product. Duramed has initiated patent litigation in the U.S. District Court for the District of New Jersey seeking injunctive relief.
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CORONA, Calif., December 14, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, confirmed today that Duramed Pharmaceuticals, Inc., a wholly owned subsidiary of Barr Pharmaceuticals, Inc., has filed a patent lawsuit against Watson and certain of its subsidiaries related to Quasense(TM) (levonorgestrel/ethinyl estradiol tablets USP), Watson's generic version of Seasonale(R), an extended cycle oral contraceptive. The lawsuit asserts that Watson's Quasense(TM) product infringes Duramed's U.S. Patent 5,895,032 ('032)....
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/Patent Docs Blog/ December 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. In this week:
Astrazeneca v. Mylan, Sun, Sandoz, Par, Apotex, Aurobindo, Cobalt (rosuvastatin); Sanofi-Aventis v. Apotex (alfuzosin); Sanofi-Aventis v. Glenmark (trandolapril, verapamil); Pfizer v. Cobalt (atorvastatin); Abbott v. Sandoz (divalproex)...
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/GenericsWeb/ London, December 16 2007 -- The intended allowance of a patent to a generic manufacturer which essentially protects any polymorphic form of tolterodine tartrate together with a carrier or diluent demonstrates that the quality of patent examination at the USPTO cannot be relied upon to filter out patent applications that are clearly not innovative from the eyes of a generic developer and that may significantly affect the level of generic competition to Pharmacia & Upjohn’s Detrol product post patent expiry.
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HAYWARD, Calif.--(BUSINESS WIRE)--Dec 17, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER, has been deemed acceptable for filing by the U. S. Food and Drug Administration (FDA) as of November 23, 2007. ...
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CHADDS FORD, PA and DANBURY, CT, Dec 17, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. announced today that on December 14, 2007, they received a notice from IMPAX Laboratories, Inc. advising of the FDA's acceptance for substantive review, of IMPAX's ANDA for oxymorphone hydrochloride extended-release tablets CII....
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ROCKVILLE, Md., Dec.18, 2007--The U.S. Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug for use in combination with other antiretroviral agents in the treatment of HIV....
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LAKE FOREST, Ill., Dec. 19 /PRNewswire-FirstCall/ -- Hospira, Inc. , the world leader in generic injectable pharmaceuticals, announced today that the European Commission (EC) has authorized it to market Retacrit (epoetin zeta), a "biosimilar" erythropoietin, for the treatment of anemia associated with chronic renal failure (administered intravenously) and chemotherapy....
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Longueuil, Quebec, December 20, 2007 - The Jean Coutu Group (PJC) Inc. (the "Company" or the "Jean Coutu Group") today announced that it had acquired Pro-Doc Ltée ("Pro-Doc"), a Quebec based generic drug manufacturer with headquarters in Laval QC. Financial terms were not disclosed....
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/Motley Fool/ December 20, 2007 -- Pharmaceutical companies' love for biotech has been generally anemic: Johnson & Johnson's (NYSE: JNJ) lackluster relationship with Amgen (Nasdaq: AMGN) in the late 1980s is a prime example. But it looks like 2007 will mark a new era for these associated industries. The reason for pharma's newfound infatuation is quite clear. Many pharmaceutical companies are facing a patent cliff in the coming years, with numerous small-molecule drugs losing market exclusivity. The companies need to replace all of those blockbusters with something. Click here to read full article (www.fool.com)...
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/PharmaTimes/ 20 December 2007 -- Growth in pharmaceutical sales this year through Canadian hospitals and drugstores (excluding online sales to US customers) is forecast to have slowed to 6.0%-6.5%, in line with total global market growth for 2007 but down from the 8.4% average rise reported for Canada annually during 2002-6, according to new projections from IMS Health. Canadian sales of generics are expected to have soared 20.1% this year, while those of innovative medicines have increased just 3.3%; moreover... Click here to read full article (www.pharmatimes.com)...
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/Generic Pharmaceuticals & Patents Blog/ December 20, 2007 -- SURREY, England, 20th December 2007 - On 13th December 2007 a revised version of the European Patent Convention (EPC) came into force. This new law, known as EPC2000, has a number of consequences for the pharmaceutical industry and the way in which patent applications are examined. In addition to implementation of EPC2000, the London Agreement is expected to enter into force in the early part of 2008. Once in force, the London Agreement will greatly reduce the costs associated with validating a granted European patent in the designated states....
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IRVINE, California, December 21, 2007 - Teva Health Systems is pleased to announce the introduction and availability of Ceftriaxone for Injection, USP. This product is AP rated to Rocephin® for Injection. Ceftriaxone for Injection is available in 250 mg/vial, 500 mg/vial, 1 gm/vial, and 2 gm/vial, in single dose glass vials, and 10 gm/vial in multiple dose glass vials....
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COLLEGEVILLE, Pa., Dec. 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , today announced it will pursue a patent infringement claim for lost profits and other damages against Teva Pharmaceuticals USA, Inc. resulting from Teva's launch of a pantoprazole tablet -- a generic version of Wyeth's PROTONIX(R)....
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JERUSALEM--(BUSINESS WIRE)--Dec 24, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that it has commercially launched Pantoprazole Sodium Delayed Release (DR) Tablets, 20 mg and 40 mg, which are AB-rated to Wyeth's erosive GERD treatment Protonix(R) DR Tablets. The brand product had annual sales of approximately $2.5 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data....
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/Business Standard/ Mumbai, December 25, 2007 -- Indian pharmaceutical companies led by Ranbaxy Laboratories have bagged 20 first-time generic approvals from the US Food and Drug Administration (FDA) in the eleven months from January to November this year, which constitutes about a quarter of the total 81 approvals given in this period. This is the highest ever first-time generic approvals for Indian companies in a year, according to industry observers. In the first corresponding period last year, Indian generic companies got just 11 first-time generic approvals (about 12.5 per cent) of a total 88 given during the 11 month period. Click here to read full article (www.business-standard.com)...
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TOKYO and WOODCLIFF LAKE, N.J., December 27, 2007 /PRNewswire/ --- Eisai Co., Ltd. and Eisai Inc. filed a lawsuit in August 2006 against Mutual Pharmaceutical Co., Inc. and United Research Laboratories, Inc. claiming that its submission of an abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) for Aricept ODT(R) (donepezil hydrochloride orally disintegrating tablets) would infringe Eisai's composition of matter patent....
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/GPhA/ 27 Dec 2007 -- The Generic Pharmaceutical Association (GPhA) will host its 2008 Annual Meeting, "Generics: the Right Choice for Better Health," on February 11-13, 2008, in Boca Raton, Florida. Featuring presentations from government, industry and Wall Street leaders, the meeting will examine the current healthcare environment and generics' critical role in promoting affordable healthcare in the United States....
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PITTSBURGH, December 28, 2007 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg....
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ALLEGAN, Mich., December 28, 2007 /PRNewswire-FirstCall/ -- Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg....
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DETROIT, December 28, 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 Cetirizine Hydrochloride Tablets, "over the counter", (OTC), 5 mg and 10 mg, (Cetirizine HCl)....
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/Orange Book Blog/ December 28, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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/Patent Docs Blog/ December 28, 2007 -- We previously reported on the passage by the U.S. Senate Committee on Health, Education, Labor & pensions of bill S.1695, entitled "The Biologics Price Competition and Innovation Act of 2007." ... The bill seeks to provide regulatory routes necessary to establish an approval process for generic biologics comprising the creation of a scientifically rigorous, efficient, and FDA-driven pathway, as well as a mechanism for timely resolution of patent disputes. An article in the Chicago Tribune by staff reporter Bruce Japsen, however, paints a less glowing picture...
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HOUSTON, Dec. 28, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced that Mitsubishi Chemical Corporation, the patent holder for Argatroban injections, Mitsubishi Tanabe Pharma Corporation, Encysive and GlaxoSmithKline have filed a patent infringement lawsuit in the U.S. District Court for the Southern District of New York against Barr Laboratories, Inc. related to Argatroban injections. ...
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RALEIGH, NC, December 28, 2007 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that, pursuant to a supply and distribution agreement with Watson Pharma, Inc., Watson will market and sell an authorized generic of COLAZAL® (balsalazide disodium) Capsules 750 mg, the Company’s anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Watson will launch the authorized generic product immediately....
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Dovetailing nicely with the continuing demand for generic drug products, Sandoz has completed a $10 million expansion at its Wilson, North Carolina, Center of Excellence site. The project added 30,000 square feet to the 170,000-square-foot facility. Sandoz is the generic arm of Swiss drugmaker Novartis....
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Patent Docs Blog/ December 30, 2007 By Donald Zuhn -- It is natural at this time of year to reflect upon the events of the past twelve months in the hope that such a review might provide some indication of what to expect in the coming year. In order to help focus on possible developments in biotech and pharma patent law in 2008, over the next three days, we will count down the top fifteen stories that we covered at Patent Docs in 2007. In addition, we will provide links to our coverage of these stories (as well as a few links to articles on related topics)...
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PITTSBURGH, December 31, 2007 /PRNewswire-FirstCall/ Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Balsalazide Disodium Capsules, 750 mg....
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PRINCETON, N.J., Dec. 31, 2007 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg....
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/Patent Docs Blog/ December 31, 2007 By Donald Zuhn -- Yesterday, we counted down the first third of the top fifteen stories that were covered on Patent Docs in 2007 (see "Top Stories of 2007: #15 to #11"). Today, we count down stories #10 to #6, and tomorrow, we will count down the top five stories. In case you missed the articles the first time around or wish to go back and review them at your convenience, we have also provided links to our coverage of these stories (as well as a few links to articles on related topics). ...
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