Generics Industry News Search
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January 2010 News Archive |
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An employee benefit plan has filed a motion to certify a class action against Biovail and GlaxoSmithKline (GSK), alleging the companies conspired to delay entry of a generic form of the antidepressant Wellbutrin XL. The plaintiffs allege that Biovail and GSK maintained exclusivity of Wellbutrin XL (bupropion HCl) by filing baseless patent infringement suits against four drugmakers - Anchen Pharmaceuticals, Impax Laboratories, Watson Pharmaceuticals and Abrika Pharmaceuticals, which is now part of Actavis - for filing ANDAs for generic Wellbutrin XL.
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Drug maker Medicines Co. said Monday it is suing a unit of Teva Pharmaceutical Laboratories Inc. and Pliva Hrvatsk claiming infringement of another patent pertaining to the company's anti-clotting agent Angiomax....
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Indian drug maker Cipla Ltd is in talks with drug companies including GlaxoSmithKline and Israel's Teva to supply generic drugs, its chairman said on Monday....
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Just a few months after losing a patent dispute over one of its blockbuster cancer drugs, Eli Lilly and Co. is in the middle of another patent fight over the same drug.
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Proposals that would allow the dispensing of generic medicines instead of branded medicines in primary care, resulting in long term savings for the NHS, were set out today by the Department of Health....
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BioVectra Inc. announced today it has signed agreements with Sandoz Inc. of Princeton, New Jersey, for Sandoz to commercialize and market the Abbreviated New Drug Application (ANDA) for Docetaxel for injection, the generic version of Taxotere, developed by BioVectra. ...
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Pfizer and Strides Arcolab today announced a new collaboration, wherein Pfizer will commercialize off-patent sterile injectable and oral products in the United States through its Established Products Business Unit. These finished dosage form products will be licensed and supplied by Strides and Onco Laboratories Limited and Onco Therapies Limited, two joint ventures between Strides and Aspen, South Africa, in which each has a 50% ownership interest. The financial terms of the supply agreement were not disclosed....
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Cephalon Inc, which makes the sleep disorder drug Nuvigil, has filed suit against generic drugmaker Watson Pharmaceuticals Inc, charging Watson with patent infringement....
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India's Wockhardt Ltd. said Wednesday it has received tentative approval from the U.S. Food and Drug Administration to sell the generic version of Forest Laboratories Inc.'s Alzheimer's and dementia drug, Namenda....
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Actavis has launched the antihypertensive drug Losartan on day one, as the patent expired in Switzerland. ...
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Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France...
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AstraZeneca PLC said Thursday it had reached an agreement with Teva Pharmaceutical Industries Ltd. that will keep generic copies of the British drug maker's heartburn drug Nexium out of the U.S. market until 2014....
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European Union regulators said Thursday that they suspect Danish drug maker Lundbeck may have delayed the launch of a cheaper, generic version of its antidepressant drug in Europe....
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc....
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Mylan manufactures and sells generic and branded drugs, including pills and transdermal patches. The recently completed Merck KGaA and Matrix acquisitions made Mylan the third-largest producer of generic drugs with the second-biggest portfolio of active pharmaceutical ingredients. Mylan's branded Dey unit (9% of total sales) markets the off-patent EpiPen injection with a better than 90% global market share. All told, they have over 130 prescription products in 39 therapeutic areas. ...
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Pennsylvania has reached a $22.5 million multi-state settlement with Abbott Laboratories, Fournier Industrie et Sante and Laboratories Fournier, S.A., who were accused of blocking competition from generic drug manufacturers.
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Mylan Inc. today confirmed that it was sued by Cephalon Inc. and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Armodafinil Tablets, 50 mg, 150 mg and 250 mg. Armodafinil Tablets are the generic version of Nuvigil(R) Tablets, which are used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsy and shift work sleep disorder. ...
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Patent settlements between drug companies will undergo European Commission scrutiny over concerns some may prevent consumers from obtaining lower-priced medicines...
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GlaxoSmithKline plc (ADR) sees little threat to its top selling drug Advair from generic competition, according to GlaxoSmithKline Chief Executive Andrew Witty....
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Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing the 250mg, 500mg and 750mg tablets of Levofloxacin, which is used for treatment in a broad spectrum of bacterial infections. Levofloxacin is the generic name for the brand Levaquin, marketed in the United States by Ortho Mcneil (Johnson & Johnson). Wockhardt will launch the product immediately upon expiration of the patent on June 20, 2011. Levofloxacin is a very widely used antibacterial drug and belongs to the fluoroquinolone group. According to IMS, the total market for Levofloxacin tablets in the US is about $1.6 billion....
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The Hatch-Waxman Act was originally designed to encourage generic drug companies to challenge the patents on name-brand medications, paving the way for cheaper drugs to occasionally enter the market before patents expire. Good, right? But somewhere along the way, the act's initial intent got twisted, leaving us with "pay-for-delay" deals that actually keep cheaper generic drugs off the market. In this arrangement, generics companies that challenge patents held by brand-name drug companies agree to settle by delaying their entry into a market in return for a payment....
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Canada's Patented Medicines (Notice of Compliance) Regulations (the "Regulations") have become the de facto means of protecting patented pharmaceuticals in Canada. Some companies list their patents on the Patent Register maintained by the Minister of Health and then wait for a generic challenge...
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San Diego-based Santarus Inc. has sued to block Par Pharmaceutical from releasing a generic version of Zegerid capsules, Santarus' treatment for stomach ulcers....
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A loophole in existing law allows manufacturers of brand-name drugs to pay competitors to keep cheaper, generic versions off the market. If there's to be health-care reform this year, it ought to close that loophole...
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Cambridge-based biotechnology company Genzyme Corp. is joining in a lawsuit against a generic-drug maker, claiming it is infringing on two patents in its manufacture of a treatment for cholesterol....
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL(R) (Colesevelam HCl) tablets, 625 mg. ...
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Lupin Pharmaceuticals, Inc. announced today that it has received 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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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5% prior to the expiration of U.S. Patent No. 5,827,529. Watson's lidocaine topical patch 5% is a generic version of Endo's Lidoderm(R). ...
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Swedish private equity group EQT will compete with Israeli Teva Pharmaceutical and US major Pfizer Inc to buy German generic drug maker Ratiopharm, German business daily Handelsblatt said today, citing financial sources. ...
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Ranbaxy Laboratories Limited today announced the signing of Agreements with Biovel Lifesciences Private Limited, Bangalore, India, providing for the acquisition of product rights and a manufacturing facility, from Biovel. ...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5% prior to the expiration of U.S. Patent No. 5,827,529...
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Mulls vigil on deals between generic and innovator firms. Indian pharmaceutical companies, which are increasingly choosing to settle patent litigation with global drug majors in the US, would have to be more cautious now...
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United States Food and Drug Administration has revoked the ban imposed on India’s Lupin Ltd's manufacturing facility at Mandideep in Madhya Pradesh, the company announced...
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Just a few months after closing its $67 billion acquisition of Wyeth Pharmaceuticals, Pfizer Inc. stands ready to spend another $4 billion or so for Germany's leading maker of generic medications, according to news reports...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application to market its generic version of Novartis' breast cancer treatment Femara (letrozole) Tablets, 2.5 mg...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a Nov. 10, 2009, District Court decision that the Company's generic version of Takeda's Prevacid (lansoprazole) SoluTab does not infringe U.S. Patent No. 5,464,632...
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Switzerland's Novartis AG said on Friday it was making progress with a generic copy of Sanofi-Aventis SA's blockbuster anti-clotting drug, Lovenox, after an analyst said Novartis was gearing up to launch its version.
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Actavis today announced the launch of Lercanidipine in five European countries. Lercanidipine is mainly used to treat high blood pressure....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough's brain tumor treatment Temodar (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct.
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Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread (tenofovir disoproxil fumarate)...
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The U.S. District Court for the District of Delaware has ruled that Bristol-Myers Squibb may proceed with its patent infringement suit against defendants Mylan Pharmaceuticals Mylan and Matrix Laboratories over Bristol-Myers' patent covering the HIV treatment Sustiva, U.S. Patent No. 6,673,372...
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Watson Pharmaceuticals, Inc., today announced that it has completed the acquisition of Eden Biopharm Group Limited for approximately $15 million. Eden is a biopharmaceutical development and contract manufacturing company located in Liverpool, UK...
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The Food and Drug Administration has given approval to a generic version of a drug used to treat high blood pressure made by an Indian drug maker....
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The Food and Drug Administration has given tentative approval to a generic version of a bone cancer drug, FDA records show....
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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 Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely laxative...
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The government of India has brought into effect stricter norms for obtaining No Objection Certificates (NOCs) for pharmaceutical exporters...
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The Medicines Co. has filed a case in the U.S. District Court for the Eastern District of Virginia appealing a ruling by the U.S. Patent and Trademark Office and others that denies extension of its patent on a heart drug, according to an 8-K filing with the U.S. and Securities and Exchange Commission....
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While many industries are struggling to survive the global financial meltdown, biological and pharmaceutical sectors remain active despite of the change of international economic climate. To many foreign companies, China remains attractive as the world's largest potential market for medical and healthcare services. As biological and pharmaceutical products rely heavily on the protection of intellectual property rights, it's essential for foreign companies in this field to gain thorough understanding of China's IPR protection system before entering this potentially largest market...
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