Wednesday 21 January, 2009

Esomeprazole Magnesium (Nexium): Innovator AstraZeneca sued Sandoz

Innovator AstraZeneca has sued another generic player over Esomeprazole Magnesium ER 20 and 40 mg capsules patents. Innovator has filed an infringement suit against Sandoz in New Jersey District Court for to protect its monopoly over the blockbuster medication after Sandoz filed ANDA with Para IV certification against Orange Book listed patents for Esomeprazole magnesium capsules.
Innovator has alleged Infringement of following patents in the complaint:
US5714504 (Expiry: Aug 3, 2015): which covers a pharmaceutical formulation for oral administration comprising a pure solid state alkaline salt of the (-)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzi midazole and a pharmaceutically acceptable carrier.
US5877192 (Expiry: Nov 27, 2014) : which covers a method for treatment of gastric acid related diseases by inhibition of gastric acid secretion comprising administering to a mammal in need of treatment a therapeutically effective amount of a proton pump inhibitor consisting essentially of the (-)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benz imidazole or a pharmaceutically acceptable salt thereof, so as to effect decreased interindividual variation in plasma levels (AUC) during treatment of gastric acid related diseases.
US6875872 (Expiry: Nov 27, 2014): which covers a Magnesium salt of (-)-5-methoxy-2-[[(4-methoxy-3,5,dimethyl-2-pyridinyl)methyl]sulfinyl]-1H- benzimidazole in an optical purity of at least about 94% enantiomeric excess.
US6369085 (Expiry: Nov 25, 2018): which covers a the magnesium salt of S-omeprazole trihydrate, with XRD and process of manugacturing the same
US7411070 (Expiry: Nov 25, 2018): which covers a the magnesium salt of S-omeprazole trihydrate.
Innovator is already in litigation with IVAX Corporation, Zenith, Teva and Dr. Reddy's for this product in New Jersey court. Earlier in April 2008, Innovator announced patent settlement with first Para IV filer Ranbaxy. As per settlement agreement, Ranbaxy will commence sales of a generic version of Nexium under a licence from AstraZeneca on May 27, 2014 onwards.

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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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