Generics Industry News Search
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AstraZeneca today announced a license and supply agreement with Torrent Pharmaceuticals Ltd. Torrent will supply to AstraZeneca a portfolio of generic medicines for which Torrent already has licenses in a range of countries. Working in partnership with Torrent, AstraZeneca intends to brand and market these products in many of its emerging markets, where it already has a strong commercial footprint...
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Watson Pharmaceuticals, Inc., today announced that it has reached a settlement agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving outstanding patent litigation related to Watson's generic equivalent version of Actos (Pioglitazone Hydrochloride) 15mg, 30mg and 45mg tablets...
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Actavis has announced the divestment of its Bulgarian distribution company, Higia EAD, to a local private investor, Rossitsa Veselinova Velikova. ...
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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analysed opportunities in launching a generic version of Abatacept. Based on its proprietary Pipeline Patent Intelligence GenericsWeb reveals that the lack of a legislated approval route and data exclusivity period for biogenerics in the US leaves generic developers of Abatacept products wondering how and when they may file for FDA approval of a biogeneric, and when they might expect to be in a position to launch...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg. Watson's Oxymorphone Hydrochloride Extended-Release Tablets product is a generic version of Endo's Opana(R) ER which is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana(R) ER had approximately $245 million in brand sales for the twelve months ending December 31, 2009, according to IMS Health...
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Taro Pharmaceutical Industries Ltd. today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Fluorouracil Topical Cream USP, 5% (fluorouracil cream). ...
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The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (Sun) in a Lanham Act case concerning the identification of a "polymorph" in the labeling of Sun's generic Protonix ...
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Pfizer Inc. wheeled out its chief executive and pledged to invest in growth as it sought to win the bidding to buy German generic drugmaker Ratiopharm GmbH, sources familiar with the situation said....
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This time, it's Teva - trying to bring a generic version of Vytorin to market. Once again, New Merck has, as of Tuesday, brought federal district court suit in New Jersey (the earlier ones were filed in Delaware), to halt that possibility - for at least 30 months...
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Pfizer Inc. said buying Ratiopharm GmbH would help the U.S. company beat generic competition and give the German drugmaker a bigger sales network in an acquisition plan presented today, according to two people with knowledge of the situation...
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Ranbaxy Laboratories Ltd, India's largest drug maker by revenue, failed to gain approval to launch the generic version of blockbuster urinary drug Flomax, but it may still get a one-time payment for enabling the launch of its generic version in the US market, according to an industry executive, who didn't want to be named...
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AstraZeneca Plc, the U.K.'s second-biggest drugmaker, sued India's Sun Pharmaceuticals Industries Ltd. to prevent it from selling a generic form of the ulcer medicine Nexium IV in the U.S. before 2014....
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Drug developer and medical products company Covidien said Wednesday it has launched a generic version of the painkiller Actiq....
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The U.S. Patent and Trademark Office has tentatively rejected certain claims in a key patent for blockbuster anti-clotting drug Plavix, which is co-marketed by Sanofi-Aventis SA and Bristol-Myers Squibb Co.
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Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Flomax (tamsulosin hydrochloride) 0.4mg 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 (FDA) for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall Capsules...
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Glenmark Generics, (GGI) USA, a subsidiary of Glenmark Generics (GGL), has received ANDA approval from the United States Food and Drug Administration for Ropinirole Hydrochloride tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva's favor by overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium)...
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Perrigo Company today announced that it has signed a definitive purchase agreement to acquire Orion Laboratories Pty, Ltd. for approximately $48 million in cash...
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Baxter International Inc., a global, diversified healthcare company, and ApaTech, a private equity-backed, U.K.-based orthobiologic products company, today announced a definitive agreement whereby Baxter will acquire all of the outstanding equity of ApaTech for total consideration of up to $330 million...
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Daiichi Sankyo Co. said Friday it will set up a new subsidiary in April to produce and sell generic drugs in Japan, in a rare move by a domestic maker of branded prescription drugs to tap the growing market of low-priced pharmaceuticals...
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You'll likely recall that last Spring, Teva said it was going to sell a generic version of Integrilin (Eptifibatide) - and legacy Schering-Plough (now New Merck) responded with a patent infringement suit - that suit covered the '825, '902 and '447 patents, as applied to a 2 mg/mL, 10 mL vial formulation of Integrilin...
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E. Fougera & Co., a leading specialty pharmaceutical manufacturer, today announced it has received first generic approval from the FDA for Imiquimod Cream 5% (Rx). Fougera's Imiquimod Cream 5% is rated AB, generically equivalent to Aldara by Graceway Pharmaceuticals and substitutable for all indications...
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A federal court has ruled in favor of Solvay Pharmaceuticals in an antitrust lawsuit brought by the Federal Trade Commission alleging that Solvay conspired with generic drug makers to postpone generic competition for a testosterone-replacement drug...
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President Obama's new proposal for health care reform was unveiled on the White House website earlier this week. According to the White House, the President's plan "builds off of the legislation that passed the Senate and improves on it by bridging key differences between the House and the Senate as well as by incorporating Republican provisions that strengthen the proposal." ...
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Watson Pharmaceuticals, Inc. a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc. Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin(TM) ER, which is indicated for major depressive disorder. ...
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In its report on so-called "pay for delay" settlements of ANDA litigation (otherwise known as "reverse payments"), the Federal Trade Commission (FTC) is calling for an outright ban on such agreements. Settlements containing "reverse payments" involved payments from the patent- and NDA-holding, branded drug company to a generic company that has filed an ANDA containing a Paragraph IV certification that an Orange Book-listed patent is invalid or unenforceable...
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Some prestigious brand-name pharmaceutical companies that once looked askance at the high-volume, low-cost business of generic drugs are now becoming major purveyors of generic medicines....
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According to Dr. Margaret A. Hamburg, the F.D.A. commissioner, Americans are waiting nearly a year longer for Generics to be approved by the government regulators than they did in 2005. ...
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The U.S. Patent and Trademark Office has tentatively rejected certain claims in a key patent for blockbuster anti-clotting drug Plavix, which is co-marketed by Sanofi-Aventis SA and Bristol-Myers Squibb Co....
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Israel-based Teva Pharmaceutical Industries Ltd. won the backing of European drug regulators to sell a generic version of the Eli Lilly & Co. bone-loss drug Evista, Bloomberg reported today.
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An Indian court ruling has halted the international pharmaceutical company Bayer's latest attempt to introduce new measures to weaken competition in drug manufacture in India. By ruling against Bayer on 9 February 2010, the Delhi High Court has refused to undermine measures in India's patent laws that help ensure access to more affordable essential medicines....
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GenericsWeb, the leader in pharmaceutical patent analysis and searching, has recently published an article based on its proprietary Pipeline Patent Intelligence to reveal a number of patents that could further delay generic versions of Gatifloxacin beyond this year's expiry of the molecule patent
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Perrigo Co. said Thursday it received marketing approval for a generic version of a medicated shampoo....
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., announced the addition of milrinone lactate in 5% dextrose injection (0.2mg/mL) in single-dose PVC flexible containers to its existing milrinone injection line. This product is AP rated and is equivalent to Primacor by Sanofi-Aventis...
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Bedford Laboratories, a division of Ben Venue Laboratories, Inc., a provider of select specialty injectables, is pleased to announce the addition of Indomethacin for Injection to its existing product line. This product is AP rated and is equivalent to Indocin by Lundbeck Inc...
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In a last ditch attempt to cover for a lawyer who filed a patent extension a day late, smallish biotech The Medicines Co. sued the FDA and the Patent and Trademark Office. It's not as crazy as it sounds. Not quite, anyway...
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A takeover contract for Ratiopharm, which is being sold to ease the debt burden of its owner, could be drawn up by the end of March, one source said...
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Intellectual property (IP) in trade agreements could endanger the poor man's access to affordable medicines, according to a veteran member of the European Parliament. ...
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Teva Pharmaceutical Industries Ltd. today announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva's U.S. generic version of Novartis' Famvir (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. Teva launched its generic famciclovir tablets in the U.S. in September 2007.
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