Tuesday, 12 January, 2010

Esomeprazole Magnesium (Nexium) 20 and 40 mg tablets: Innovator Astra settled patent litigation with Teva

Innovator Astra settled patent litigation with Teva pending in the U.S. District Court for the District of New Jersey

After first settling with first paara IV filer Ranabxy in April, 2008, innovator M/S AstraZeneca has entered into a licensing agreement with generic player Teva and as per terms of the settlement Teva would be able to launch the generic version in May 27, 2014 (after the expiry of two key Orange Book listed patents US5877192 and US6875872), onwards.

Teva has admitted the validity of following Orange Book patents:










The other generic players like Sandoz, Dr. Reddy's and Lupin are in patent litigation with innovator, the litigation is pending in New Jersey District Court.

Monday, 4 January, 2010

Paragraph IV Patent Certifications Reported by USFDA as of December 22, 2009

1. Amlodipine Besylate and Atorvastatin Calcium (Caudet) 2.5 mg + 40 mg Tablets: Para IV filed on Sep 17, 2009

2. Arformoterol Tartrate (Brovana) Eq. 0.015 mg base/2 mL Inhalation Solution: Para IV filed on Oct 1, 2009

3. Niacin and Simvastatin (Simcor)1000 mg + 20 mg Extended-release Tablets: Para IV filed on Sep 17, 2009

4. Vardenafil Hydrochloride (Levitra) 2.5 mg Tablets: Para IV filed on Sep 4, 2009

Source: USFDA Para IV certification list Here

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
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