Generics Industry News Search
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January 2009 News Archive |
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It appears that China is poised to become one of the new centers of innovation. China intends to soon grant more patents than any other country and expects to entice most of the top pharmaceutical companies to conduct R&D; within its borders. ...
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Teva Pharmaceutical Industries Ltd, the world's biggest maker of generic drugs, paid $7 million to settle a suit claiming it charged illegally inflated prices to Massachusetts' Medicaid program...
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Codexis, Inc. today announced a licensing agreement with Teva Pharmaceutical Industries Ltd., to produce an important publicly- undisclosed generic product, using a proprietary Codexis biocatalyst. Teva, the largest generic drug manufacturer in the world, is a leading producer of this generic product....
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The Delhi High Court has asked the drug controller general of India not to give marketing or manufacturing permission to generic drugmakers for any drugs which have patent in India...
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Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from USFDA for several Abbreviated New Drug Applications (ANDA). Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. Approval was also received for generic Aredia, pamidronate disodium for injection USP, generic Lopid, gemfibrozil tablets, USP, and generic Phenargan, promethazine hydrochloride tablets...
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Sun Pharmaceutical Industries Ltd. today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd., has extended the Expiration Date of the Tender Offer for the purchase of all outstanding Ordinary Shares of Taro Pharmaceutical Industries Ltd. The Offer will now expire at 5:00 p.m., New York City time, on Friday, January 30, 2009, unless further extended or earlier terminated...
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Analysts say the firm filed the generic drug application from a facility that is under the US FDA scanner...
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IMPAX Laboratories, Inc. today announced that Eurand, Inc., Cephalon, Inc., and Anesta AG have filed suit for patent infringement in the United States District Court for the District of Delaware based on the Company's submission of Abbreviated New Drug Application for cyclobenzaprine hydrochloride extended release capsules (15 and 30 mg), generic of Amrix, to the Food and Drug Administration...
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Watson Pharmaceuticals, Inc. and Warner Chilcott Limited announced today that they have entered into Settlement and License Agreements to resolve pending patent litigation related to Warner Chilcott's oral contraceptive products, Loestrin 24 and Femcon Fe...
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A recent order by the Delhi high court in favour of US drug maker Bristol-Myers Squibb Co. will effectively link India's drug regulatory process with its patent regime, throwing the country's huge and profitable generics or off-patent drugs industry into a tizzy...
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Mylan Inc. today announced that its subsidiary Dey L.P. has been issued several additional U.S. patents protecting the company's Perforomist Inhalation Solution, a chronic obstructive pulmonary disease (COPD) treatment.
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Medicis Pharmaceutical Corp., the maker of skin medicines, sued Mylan Inc., Teva Pharmaceutical Industries Ltd.'s Barr Laboratories and other companies to block generic versions of Medicis's Solodyn acne drug....
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Eli Lilly & Co. came under heavy questioning Wednesday in federal appeals court over its bid to maintain a ruling that bars Teva Pharmaceutical Industries Ltd. from marketing a generic version of Evista, but it wasn't clear how the three-judge panel would rule.
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Oscient Pharmaceuticals Corp. and a handful of affiliates have filed a patent-infringement suit in Maryland district court against Lupin Pharmaceuticals and its parent company Lupin Limited, based in India....
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Alembic, a leading pharmaceutical company in India, announced that it had received an approval for a new drug, Lithium Carbonate from USFDA (United States Food and Drug Administration). ...
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Orion Corporation filed a patent infringement lawsuit in the United States to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA LLC and Wockhardt Limited, who seek to market generic versions of Orion Corporation's proprietary drug, Stalevo...
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Two of the leading generic companies have come up for sale at the same time – Actavis and Ratiopharm. A good start to the New Year for the M&A; specialists who will advise and guide the sales but a sad reflection of how the recession is beginning to hit even the generic industry.
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Pharma major, Lupin Ltd. announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. has received the final approval for the Company's Abbreviated New Drug Application for Levetiracetam Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S. Food and Drug Administration...
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Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration has granted final approval of the company's abbreviated new drug application for Levetiracetam Oral Solution, 100 mg/mL
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Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd., a subsidiary of Hospira, Inc., have filed a lawsuit against Sandoz Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers DORYX, a tetracycline-class oral antibiotic...
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Teva Pharmaceuticals is pleased to announce the introduction and availability of Levetiracetam Tablets. This product is AB rated and bioequivalent to Keppra Tablets...
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Danish pharmaceutical group Lundbeck is interested in acquiring Irish biotechnology firm Elan, the Sunday Independent newspaper reported, without citing any sources...
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Teva Pharmaceutical Industries Ltd. and Lonza Group Ltd. today announced their agreement to establish a joint venture to develop, manufacture and market a portfolio of biosimilars. Through this joint venture, Lonza and Teva bring together highly complementary capabilities that will significantly advance the partners' efforts to secure a leading position in the emerging biosimilars market...
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GeoPharma, Inc. announced today that it has reached agreement with the Schering Corporation, and Sepracor, Inc. and the University of Massachusetts settling all Hatch-Waxman litigation relating to Desloratadine tablets (5 mg)...
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Scolr Pharma, Inc. today announced that the U. S. Food and Drug Administration (FDA) has issued a Complete Response letter for its Abbreviated New Drug Application (ANDA) for pseudoephedrine. The application, filed by Scolr on August 5, 2008, seeks approval to market a 120 mg 12 hour pseudoephedrine tablet based on its patented Controlled Delivery Technology (CDT(R)) platform....
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APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Rocuronium Bromide Injection, the generic equivalent of Organon's Zemuron. ...
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Actavis has received approval from the US Food & Drug Administration (FDA) to market Levetiracetam Oral Solution. Distribution of the product has commenced....
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A US District Court has invalidated two of the three patents King Pharmaceuticals held over its top-selling drug Skelaxin (metaxalone).
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King Pharmaceuticals, Inc. reported today that the U.S. District Court for the Eastern District of New York in the case of King Pharmaceuticals, Inc., et al. v. Eon Labs, Inc., Case No. 04-cv-5540 (DGT), issued an Order invalidating United States Patent Nos. 6,407,128 and 6,683,102, two patents relating to SKELAXIN (metaxalone). The Company plans to appeal the Order, which was issued in response to Eon's motion for summary judgment without the benefit of a hearing....
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Myriad Pharmaceuticals, Inc. today announced that it has acquired all rights to bevirimat from Panacos Pharmaceuticals, Inc. for an upfront payment of $7M.
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Israel's Teva Pharmaceutical Industries Ltd has won backing from European regulators for its hepatitis C drug Ribavirin Teva, a generic version of Schering-Plough Corp's Rebetol....
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Three generic drug-makers have filed regulatory applications to make cheaper versions of Elestat, an allergy medicine made by Allergan and sold by Inspire Pharmaceuticals of Durham....
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IMPAX Laboratories, Inc., through its generic drug division Global Pharmaceuticals, announced that yesterday the U.S. Food and Drug Administration granted final approval of the Company's Abbreviated New Drug Application for a generic version of Prilosec 40 mg Delayed-release Capsules...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its supplemental Abbreviated New Drug Application for Omeprazole Delayed-release (DR) Capsules USP, 40 mg, the generic version of AstraZeneca's Prilosec DR Capsules...
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Hospira Inc.'s bid to dominate a new, lucrative slice of the pharmaceutical market is under threat from some of the world's largest drugmakers. Lake Forest-based Hospira is the only U.S. company selling copycat versions of biotechnology drugs...
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Medimetriks Pharmaceuticals announced today that the Company has entered into a Distributor Agreement with Perrigo Company, a leading manufacturer in the generic prescription marketplace, designating Perrigo as the Exclusive Authorized Distributor of generic versions of Medimetriks' branded products in the U.S...
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KV Pharmaceutical has voluntarily suspended the manufacturing and shipping of all of its products, other than certain products that it distributes but does not manufacture. The suspension began on January 22, 2009....
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Watson Pharmaceuticals, Inc., a leader in generic and specialty branded pharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has approved GELNIQUE(TM) (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. The U.S. OAB market currently exceeds $1.8 billion annually and continues to grow each year. ...
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Procter & Gamble Co. and Hoffmann-La Roche Inc. have filed a lawsuit accusing generic-drug maker Sun Pharma Global Inc. of infringing a patent related to the dosage formula for a once-a-month version of the companies' osteoporosis treatment Actonel...
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Baxter Healthcare Corp. has sued Minrad Inc. for allegedly planning to make a generic version of Baxter's liquid anesthetic Suprane, which Baxter claims would infringe a Baxter patent...
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Mylan Inc. today announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets. Genpharm also received final FDA approval for its ANDA for a separate Lamotrigine product, Lamotrigine Tablets Chewable Dispersible (CD). ...
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RxElite, Inc. announces the sale of all the issued and outstanding capital stock of RxElite Holdings Inc. ("Holdings"), its wholly owned U.S. subsidiary, to Piramal Healthcare Limited ("Piramal") for cash consideration of approximately $4.2 million. In addition, approximately $3.2 million of outstanding indebtedness and accrued interest due to an affiliate of Piramal was assumed by Holdings and is no longer an obligation of RxElite, Inc. A significant portion of the net proceeds from the sale will be used by RxElite, Inc. to retire a portion of its long-term debt....
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Minrad International has been sued by pharmaceutical giant Baxter Healthcare Corp. in an attempt to stop the Orchard Park anesthesia manufacturer from developing and selling a generic version of Baxter's Suprane anesthesia. ...
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Taro Pharmaceutical Industries, a multinational, science-based pharmaceutical company, has received final approval from the FDA for its abbreviated new drug application for lamotrigine tablets 25mg, 100mg, 150mg, and 200mg....
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., begins shipping Irinotecan HCl Injection. This product is AP rated and equivalent to Camptosar by Pfizer. Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following intial fluorouracil-based therapy...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of Janssen's antipsychotic agent Risperdal (Risperidone) Oral Solution, 1 mg/mL...
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Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. have filed a lawsuit against Actavis Elizabeth LLC in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers Doryx, a tetracycline-class oral antibiotic...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Divalproex Sodium Extended-release Tablets, 250 mg and 500 mg...
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