Warner files lawsuit for Infringement of Doryx (US 6,958,161) Patent

Warner and one of its subsidiaries and "Mayne", 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 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

Warner markets and sells DORYX DR tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne. Warner Chilcott previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. on December 23, 2008. The lawsuit is in response to the submission of an ANDA) to the USFDA by Sandoz requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg DR tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.

patentmarvel-a boon for downloading US patents/publications

IPblogger has come across a very useful site for patent downlaoding. The site patentMarvel.com is the place for intellectual property tools designed to make life easier. The patentMarvel's PDFinducer tool allows you to easily view and download US patents and published patent applications as PDF's. Simply input the US patent number or US publication number and let patentMarvel do the rest. If you would like to create multiple PDF's at one time just separate the numbers with semicolons.

Lupin receives USFDA approval for Levetiracetam tablets

Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the Company's ANDA for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg from the USFDA. Commercial shipments of the product have commenced. Lupin's Levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals' Keppra(R) tablets, indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy.

Cypress receives FDA approval of Levetiracetam oral solution

Cypress has been granted final approval by USFDA for it's ANDA for Levetiracetam Oral Solution, 100 mg/mL. Levetiracetam Oral Solution, 100 mg/mL is the AB-rated bioequivalent generic to UCB Pharma's Keppra® Oral Solution, 100 mg/mL.

Prasugrel receives positive opinion from CHMP

Daiichi Sankyo and Eli Lilly and Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name Efient.

Freepatents online creates another landmark by introducing citepatents

FreePatentsOnline.com (FPO), one of the widely used free online search engines for patents has launched an informational site, http://www.citepatents.com/, particularly to help bloggers, journalists and others to easily reference to patent information, and to provide a free patent search box for adding to websites with a single mouse click.

One has to log in by creating a free account first. Another useful free patent search site launched by the FPO is SumoBrain with a powerful new feature of bulk PDF downloading from a database of tens of millions of records including US patents and published applications, European patents and published applications, and WO publications at a single go. SumoBrain also features basic and advanced search capabilities including field search, word stemming, proximity search and search term weighting. SumoBrain saves lot of time and capital investment. Ipblogger would suggest its esteemed readers to login to this website and benefit from its advantages.

RANBAXY reconstitutes Board of Directors

Ranbaxy and Daiichi Sankyo Company Limited have announced the reconstitution of Ranbaxy’s Board of Directors. The composition of the new Board reflects the new ownership structure at Ranbaxy following Daiichi Sankyo’s strategic investment completed in November 2008. Daiichi Sankyo now holds 63.92% of the equity share capital of Ranbaxy.

The detailed news can be viewed by our privileged readers from linking into this site

Pfizer sues Apotex for infringement of '995 patent

Innovator Pfizer sued Canadian pharma giant Apotex (as per complaint filed on December, 17, 2008 in federal court in Wilmington, Delaware) for filing ANDA with Para IV certification to United States Food and Drug Administration (USFDA) to import and sell 10, 20, 40 and 80 mg/tablet dosage strengths of the Atorvastatin Hemicalcium, in violation of a enantiomer patent listed in Orange Book.

For a detailed action filed by Pfizer, click here

NovaDel Pharma receives FDA Approval of Zolpimist

NovaDel Pharma's Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the USFDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist is NovaDel's second product approved by the FDA that uses NovaDel's proprietary NovaMist oral spray technology. Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien®, the world's leading sedative hypnotic for the treatment of insomnia.

Aurobindo receives USFDA tentative nod for Abacavir Sulfate/Lamivudine tablets FDC

Hyderabad based Aurobindo Pharma Limited has received tentative US FDA approval to manufacture and market fixed dosed combination Abacavir Sulfate/Lamivudine tablets 60/30mg for the treatment of HIV infections.

The company had earlier received tentative approvals to co-packaged Lamivudine/Zidovudine tablets + Abacavir Sulfate tables 150/300mg + 300mg and Abacavir Sulfate/Lamivudine tablets 600/300 mg. This is Aurobindo 87th ANDA approval from US FDA, a company release said.