Orion Corporation has confirmed that it has received Paragraph IV certification from SunPharma against Orange book listed patents for Comtan (Entacapone, 200mg tablets). USFDA approved this product on Oct 19, 1999. Patentee Orion Pharma has licensed this molecule to Novartis. Orion previously sued Sun Pharmaceutical Industries Ltd. for patent infringement when it challenged certain Orion U.S. patents as part of an earlier filed ANDA on a generic version of Orion's proprietary drug, Stalevo as reported earlier by IPPharmadoc Here . That action is pending in the District Court for the District of New Jersey.
US4963590 (Expiry: Nov 27, 2007): Claims Pharmaceutical composition and method of use of catechol-O-methyl transferase inhibitor
US5112861 (Expiry: May 12, 2009): Method of use with Entacapone and levodopa
US5135950 (Expiry: Oct 31, 2010): Crystallographically essentially pure polymorphic form A
US5446194 (Expiry: Oct 19, 2013): Covers Entacapone as product
US6599530 (Expiry: Sep 14, 2018): Covers an oral compacted composition in the form of a tablet, which comprises a pharmaceutically effective amount of entacapone, nitecapone, or pharmaceutically acceptable salt of entacapone or nitecapone, and croscarmellose sodium in an amount of at least 6% by weight of the composition.
Entacapone is a catechol-O-methyl transferase inhibitor for the treatment of Parkinson's disease. When administered in conjunction with dopaminergic agents such as L-DOPA, entacapone increases the bioavailability of these compounds by facilitating their passage across the blood-brain barrierFurthermore, Wockhardt is first Para IV filer on this product and innovator Orion sued Wockhardt for in the District Court of Delaware. Sun Pharma has challenged product patent ‘194 and formulation patent ‘530. Also, Sun has not challenged method of use patent ‘861 and crystalline polymorph patent ‘950. From this filing, it can be concluded that Sun pharma intend to enter into the market after the expiry of ‘950 patent on Oct 31, 2010
US4963590 (Expiry: Nov 27, 2007): Claims Pharmaceutical composition and method of use of catechol-O-methyl transferase inhibitor
US5112861 (Expiry: May 12, 2009): Method of use with Entacapone and levodopa
US5135950 (Expiry: Oct 31, 2010): Crystallographically essentially pure polymorphic form A
US5446194 (Expiry: Oct 19, 2013): Covers Entacapone as product
US6599530 (Expiry: Sep 14, 2018): Covers an oral compacted composition in the form of a tablet, which comprises a pharmaceutically effective amount of entacapone, nitecapone, or pharmaceutically acceptable salt of entacapone or nitecapone, and croscarmellose sodium in an amount of at least 6% by weight of the composition.
Entacapone is a catechol-O-methyl transferase inhibitor for the treatment of Parkinson's disease. When administered in conjunction with dopaminergic agents such as L-DOPA, entacapone increases the bioavailability of these compounds by facilitating their passage across the blood-brain barrierFurthermore, Wockhardt is first Para IV filer on this product and innovator Orion sued Wockhardt for in the District Court of Delaware. Sun Pharma has challenged product patent ‘194 and formulation patent ‘530. Also, Sun has not challenged method of use patent ‘861 and crystalline polymorph patent ‘950. From this filing, it can be concluded that Sun pharma intend to enter into the market after the expiry of ‘950 patent on Oct 31, 2010
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