Tuesday 9 December, 2008

Stalevo (Carbidopa+Entacapone+Levodopa: 12.5+200+50 mg ): Innovator sued Wockhardt

Innovator Orion announced Here that they had sued generic player Wockhardt for filing Para IV certification against Orange Book listed patents for Stalevo (Carbidopa+Entacapone+Levodopa: 12.5+200+50 mg ) in the United States.
As reported earlier by IPPharmadoc Here, Wockhardt send Para IV notice letter for this product to innovator in November this year.
Following patents are listed in orange book for this product:
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
US6500867(Expiry: Jun 29, 2020): Covers An oral solid tablet composition comprising pharmacologically effective amounts of Entacapone, Levodopa, and Carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and a pharmaceutically acceptable excipient, wherein a substantial portion of carbidopa or a pharmaceutically acceptable salt or hydrate thereof is separated from entacapone and levodopa or pharmaceutically acceptable salts or hydrates thereof in the tablet.
US6797732 (Expiry: Jun 29, 2020): A stable oral solid composition comprising pharmacologically effective amounts of active agents consisting of Entacapone, Levodopa, and Carbidopa, or pharmaceutically acceptable salts or hydrates thereof, and comprising at least one pharmaceutically acceptable excipient other than microcrystalline cellulose
Wockhardt has challenged innovator’s ‘950, ‘194‘, 867 and ‘732 patents listed in the Orange Book. Innovator in it’s complaint has alleged infringement of ‘950, ‘194 and ‘867 patents. Earlier in January this year, another Indian drug major, Sun Pharmaceutical Industries, had challenged three patents of Stalevo. The latest of Stalevo's six US patents are to expire by October 31, 2010. The drug was given marketing permission by the USFDA in June 2003.
Update
Innovator Orion announced (Here) that they have also received Para IV notice letter from Wockhardt against other strengths of Stalevo (Carbidopa+Entacapone+Levodopa) like 25+200+100; 37.5+200+150 and 50+200+200 mg strengths

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