Generics Industry News Search
 |
|
|
|
|
|
|
November 2007 News Archive |
|
|
| |
|
LONDON, Nov. 1, 2007-On 30th October 2007, AstraZeneca received a notice-letter from Cobalt Pharmaceuticals, Inc. (“Cobalt”) notifying AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals Inc., and Shionogi Seiyaku Kabushiki Kaisha that Cobalt had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for approval to market generic rosuvastatin calcium tablets....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
EXETER, N.H.--(BUSINESS WIRE)--Nov 1, 2007 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products, today announced its European subsidiaries have received their first product approval in France, which is for Lansoprazole, a generic version of Prevacid(R)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
ALLEGAN, Mich., November 01, 2007 /PRNewswire-FirstCall/ -- Perrigo Company announced today that Dexcel Pharma Technologies, Ltd. ("Dexcel"), Perrigo's partner for store brand OTC 20mg Omeprazole delayed release tablet, has settled its patent litigation with AstraZeneca (the manufacturer of Prilosec OTC(R)) involving three Orange Book patents ('380, '230 and '505) relating to the product....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Republished from Orange Book Blog/ November 01, 2007 -- Bayer AG v. Dr. Reddy's Laboratories, Ltd., No. 04-179 (D. Del. 2007)
Last Thursday, the U.S. District Court for the District of Delaware held that two Bayer patents on Avelox (moxifloxacin hydrochloride) are valid and enforceable, and infringed by Dr. Reddy's ANDA for a generic version of Avelox. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
NORWALK, CONN, Nov. 1, 2007 – The global pharmaceutical market is expected to grow at a 5 - 6 percent pace next year, compared with 6 - 7 percent in 2007, according to IMS Health’s 2008 Global Pharmaceutical Market and Therapy Forecast released today. The forecast, the leading annual industry indicator of market dynamics and therapy performance, predicts global pharmaceutical sales to expand to US$735 - 745 billion next year....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
WOODCLIFF LAKE, N.J., Nov. 2 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Novartis Pharmaceuticals Corporation in connection with its Ritalin(R) LA (methylphenidate hydrochloride) extended-release capsules, 10mg, 20mg, 30mg and 40mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ November 02, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/NYTimes.com/ November 3, 2007 -- It is shaping up to be the biggest shift yet to a generic drug, potentially saving the nation $2 billion a year or more in prescription costs. And scientists and doctors say that for most of the 16 million people in America who take drugs to reduce cholesterol, the low-priced alternative will work as well as the name-brand medicine — Lipitor ... The generic version of Zocor, simvastatin, is now much cheaper than Lipitor, leading insurers to press doctors and patients to switch. But Pfizer is not letting its flagship drug go down without a fight. Click here to read full article (www.nytimes.com)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 04, 2007 -- On October 26th, the Federal Circuit affirmed a District Court's finding on summary judgment that certain claims of U.S. Patent Nos. 6,593,318 (the '318 patent) and 6,593,320 (the '320 patent) were invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement. The '318 and '320 patents are directed to stable flocculated suspensions of megestrol acetate (see below) and methods for making such suspensions....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 04, 2007 -- 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: Celgene v. Barr (methylphenidate); Elan v. Actavis (dexmethylphenidate); Medeva v. Roxane (mesalamine); Aventis v. Dr. Reddy's (fexofenadine); Sepracor v. Perrigo (desloratidine)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
KENILWORTH, N.J., November 05, 2007 /PRNewswire-FirstCall/ -- Schering-Plough Corporation reported that the U.S. District Court for the District of Massachusetts has found no liability for Warrick Pharmaceuticals, its generic subsidiary, in a class action lawsuit involving several pharmaceutical companies and the setting of average wholesale prices (AWPs) for prescription products....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CARSON CITY, Nev., November 05, 2007 /PRNewswire-USNewswire/ -- The following was issued by the National Community Pharmacists Association: Pharmacist press conference to discuss new Medicaid generic prescription drug reimbursement rule and need for Senate Majority Leader Harry Reid (D-Nev.) 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 to their services at risk....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Intellectual Property Watch/ 5 November 2007 -- BANGKOK - Thai government officials said the latest round of negotiations with patent owners of cancer treatment drugs showed positive results with drug companies agreeing to make their supplies more available to certain cancer patients.
But they stopped short of saying that the government would now have no need to impose compulsory licences on these drugs....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Republished from Orange Book Blog/ November 06, 2007 -- Pharmaceuticals markets Altace (ramipril), a treatment for high blood pressure with nearly $1 billion in annual U.S. sales. U.S. Patent No. 5,061,722, owned by Aventis and licensed to King, is listed in the Orange Book for Altace. Cobalt Pharmaceuticals submitted the first ANDA with a paragraph IV certification to the '722 patent in 2002, thereby earning 180-day exclusivity for ramipril (and thereby establishing this as a "pre-MMA" case)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CORONA, Calif., November 07, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of YAZ(R) tablets prior to the expiration of patents owned by Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (Bayer)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CLEVELAND, November 07, 2007 /PRNewswire/ -- Continuing to deliver upon its commitment to improving the health and wellness of its customers, supermarket retailer Giant Eagle, Inc. today announced that effective this Thursday, November 8, 2007, the company will expand its popular $4 generic prescription medication program drugs to a total of more than 400....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
BS Reporter / Mumbai November 7, 2007
Glenmark Pharmaceuticals today announced plans to hive off its generics business to a new company Glenmark Generics (GGL). The reorganisation is aimed at building build end-to-end integration, scale and capabilities in pursuing its generic business with GGL, and global capabilities similar to a big pharma company with the parent company Glenmark Pharmaceuticals. GGL will be a wholly-owned subsidiary of Glenmark Pharmaceuticals, and will be listed on the Indian bourses by Q1FY09. Click here to read full article (www.business-standard.com)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
GURGAON, India and PRINCETON, N.J., November 08, 2007 /PRNewswire/ -- Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Company has reached an agreement with Astellas/Boehringer Ingelheim to stipulate a remand of the pending Federal Circuit appeal and subsequent vacatur of the District Court decision in regards to Flomax(R) (Tamsulosin capsules)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
MERIDIAN, Idaho, November 08, 2007 /PRNewswire-FirstCall/ -- RxElite Holdings, Inc., a wholly- owned operating subsidiary of Southridge Technology Group, Inc. and a developer, manufacturer, and marketer of specialty generic prescription drug products, announced today that the Board of Directors approved the Company to change its name and trading symbol to RxElite, Inc. As of November 7, 2007, RxElite, Inc. is trading under the symbol RXEI on the OTC bulletin board....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 08, 2007 -- AstraZeneca and Israeli generic drug manufacturer Dexcel Pharma recently settled litigation involving the 20 mg delayed-release formulation of omeprazole (Prilosec®). Under the agreement, Dexcel and its partner, Perrigo Company, will have the exclusive marketing rights to the store-branded OTC version of omeprazole....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 08, 2007 -- Ranbaxy Laboratories, Astellas Pharma US, Inc., and Boehringer Ingelheim Corporation have announced their agreement to enter into a joint stipulation of dismissal without prejudice in their lawsuit over FLOMAX® (tamsulosin hydrochloride, used to treat benign prostatic hyperplasia)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
ARLINGTON, VA, November 8, 2007-- The Generic Pharmaceutical Association (GPhA) today praised the House of Representatives for its strong bipartisan approval of the U.S.-Peru Free Trade Agreement, which proves that our nation’s free trade agreements can foster innovation while also ensuring that our trading partners have access to safe and affordable medicines.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Guardian Unlimited/ TOKYO, Nov 9 (Reuters) - Japan's Health Ministry, eager to trim swelling health-care costs, proposed changes to prescription forms on Friday in a bid to boost the use of cheaper generic drugs, sending shares in the nation's generic drug makers soaring.
The move reflects a global trend by governments and insurers to maximise the use of generic medicines, which are becoming increasingly available for a range of drugs as patents expire or are overturned in legal cases. Click here to read full article (www.guardian.co.uk)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ November 10, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 11, 2007 -- 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: Alcon v. Barr (olopatadine); Connetics v. Pentech (betamethasone valerate); Bayer v. Watson (drospirenone); Glaxo v. Teva (lamivudine & zidovudine); Sepracor v. Lupin (desloratidine);
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/BioWorld Today/ 12 November 2007 -- The FDA's stance on generics - at least on versions of the blood thinner Lovenox, such as Momenta Pharmaceuticals Inc.'s M-Enoxaparin (and probably similar compounds from Teva Pharmaceuticals Industries Ltd. and Amphastar Pharmaceuticals Inc. - became somewhat clearer last week, sadly and surprisingly for hanging-on Momenta investors who watched the stock's value tumble 58 percent, closing at $5.67. Word that the agency wants more immunogenicity data on M-Enoxaparin led... Click here to read full article (www.bioworld.com)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
DETROIT, November 12, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Lamotrigine Tablets (lamotrigine), 25 mg, 100 mg, 150 mg, and 200 mg. Final approval to market this product is anticipated subsequent to the expiry of patent protection on January 22, 2009....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
ESPOO, Finland, Nov. 13, 2007--Orion Corporation has filed a patent infringement lawsuit in the United States to enforce its formulation patent, U.S. Patent No. 6,500,867, against Sun Pharmaceutical Industries Inc. and Sun Pharmaceutical Industries Limited, who seek to market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/AP-Google/ Nov 13, 2007 -- WASHINGTON (AP) — Legislation aimed at speeding the availability of cheaper generic drugs has stalled in Congress in the face of major lobbying by the drug industry. The Senate bill would ban most settlements known as "reverse payments," in which a brand-name company pays a generic manufacturer to delay the introduction of the generic drug ... An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation... Click here to read full article (ap.google.com)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ November 14, 2007 -- Recent updates to the Hatch-Waxman Tracker maintained by Aaron Barkoff of the Orange Book Blog....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CHADDS FORD, PA and DANBURY CT, Nov 15, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Inc., a subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that they have filed a lawsuit against IMPAX Laboratories, Inc. in the United States District Court for the District of Delaware in connection with IMPAX's ANDA for Opana(R) ER (oxymorphone HCl)
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 18, 2007 -- 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: Eisai v. Teva (donepezil); Celgene v. Barr (thalidomide); Orion v. Sun (entacapone, levodopa, and carbidopa); BASF Agro v. Cipla (fipronil); Aventis v. Hospira (docetaxel); Sanofi-Aventis v. Pharmachemie (oxaliplatin); Celgene v. Actavis (dexmethylphenidate); ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
HAYWARD, Calif.--(BUSINESS WIRE)--Nov 19, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today confirmed that Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. have filed a lawsuit against the Company in the United States District Court for the District of Delaware alleging patent infringement related to IMPAX's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
WOODCLIFF LAKE, N.J., November 20, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed for Focalin(R) XR (dexmethylphenidate hydrochloride) extended-release capsules, 5mg, 10mg, 15mg & 20mg. Focalin XR is manufactured for the U.S. for Novartis Pharmaceuticals Corporation by Elan Holdings Inc....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
TORONTO, Nov. 20 /CNW/ -- Ranbaxy Pharmaceuticals Canada Inc. (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL had received approval in Canada to manufacture and market Tamsulosin Hydrochloride Capsules 0.4 mg from Health Canada, Therapeutic Products Directorate (TPD). This product has proven to be bio- equivalent to Flomax(R) Capsules which is indicated for the treatment of Benign Prostatic Hyperplasia (BPH)....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Business Standard/ P B Jayakumar / Mumbai November 22, 2007 -- The Indian pharmaceutical companies are involved in patent litigations of a mere 40 drugs, out of the 135 known patent litigation drugs in the US. This is despite the claims by major Indian players such as Ranbaxy and Dr Reddy’s at having secured over 20 first to file (FTF) status abbreviated new drug applications (ANDA) with the US Food and Drug Administration (USFDA)... Click here to read full article (www.business-standard.com)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
Nov 23 2007 Mumbai: US drugs regulator food and drug administration (FDA) has accepted a generic challenge by India’s Sun Pharmaceuticals Industries Ltd against Glivec, a controversial mega-earner cancer drug of Novartis AG, potentially weakening the Swiss drug maker’s petition against an Indian ruling denying the drug a patent. The challenge in the US, if it invalidates Novartis’ patent, will not only significantly strengthen the plea of local drug makers here, but also open up a huge generics market for them in the US for this drug, which, last year, grossed some $2.5 billion (Rs11,605 crore then), equivalent to more than one-10th of Novartis’ revenues. Click here to read full article (www.livemint.com)
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 25, 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. Banner (divalproex); Novartis v. Hoffmann-La Roche (enfuvirtide); Elan v. Barr (dexmethylphenidate); Celgene v. Barr (dexmethylphenidate); Endo v. Impax (oxymorphone); Teva v. Apotex (carvedilol)...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Patent Docs Blog/ November 26, 2007 -- Last month, Astellas Pharma Inc., King Pharmaceuticals, Inc., and Teva Pharmaceutical Industries Ltd. announced that U.S. subsidiaries of Astellas, along with Item Development AB and King have signed settlement agreements with respect to U.S. Patent Nos. 5,731,296 and 5,070,877. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
CORONA, Calif., November 27, 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 Oxycodone Hydrochloride and Ibuprofen Tablets (CII) in the 5 mg/400 mg strength. ...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
STAMFORD, Conn., Nov. 27 /PRNewswire-FirstCall/ -- Purdue Pharma L.P. today announced that IMPAX Laboratories, Inc. and its distributor DAVA Pharmaceuticals will resume sales of a limited amount of IMPAX's generic version of Purdue's OxyContin(R) (oxycodone HCl extended-release) Tablets on November 27, 2007, 2007 pursuant to the agreement the companies signed on March 30, 2007 to resolve then pending patent litigation....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
WOODCLIFF LAKE, N.J., November 29, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) for its application to manufacture and market a generic version of Forest Pharmaceuticals, Inc.'s Combunox(R) (oxycodone HCl and ibuprofen) tablets, 5mg/400mg....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ November 28, 2007 -- Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998. In October 2005, Hi-Tech Pharmacal filed the first ANDA for a generic version of Cosopt with paragraph IV certifications to the Orange Book-listed patents: U.S. Patent Nos. 4,797,413; 6,248,735; and 6,316,443....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ November 29, 2007 -- The Lovenox patent infringement litigation between Aventis and Teva/Amphastar is making its second trip to the Federal Circuit. In February, following remand from the Federal Circuit last year, a federal district court in California held that the Lovenox patent is unenforceable due to inequitable conduct. The appeal may emerge as a litmus test of how far the CAFC is willing to go in lowering the bar on inequitable conduct, especially in terms of what it takes to prove deceptive intent....
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
JERUSALEM--(BUSINESS WIRE)--Nov 30, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's Requip(R) (Ropinirole HCl) Tablets...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
DETROIT, November 30, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets (escitalopram), 5 mg, 10 mg, and 20 mg.
...
|
| |
|
|
Read more >>
|
| |
|
|
|
| |
|
/Orange Book Blog/ November 30, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
|
| |
|
|
Read more >>
|
| |
|
|
|
|
|
Contribute
If you would like to contribute or publish your
company press releases at GenericsWeb, please
email us.
|
Home
