Indian Pharma company Wockhardt has challenged the US patent of Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.
Wockhardt has filed an abbreviated new drug-marketing application (ANDA) with the USFDA, seeking authorisation to produce and market a generic version of Stalevo in 12.5, 200 and 50 mg strengths, announced Orion Corporation.
Orion, together with Novartis, is currently evaluating legal options to protect its rights, and at this point. The ANDA review process is just beginning and the realisation of generic competition is neither certain, nor imminent.
In early 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 FDA in June 2003. 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
Wockhardt has filed an abbreviated new drug-marketing application (ANDA) with the USFDA, seeking authorisation to produce and market a generic version of Stalevo in 12.5, 200 and 50 mg strengths, announced Orion Corporation.
Orion, together with Novartis, is currently evaluating legal options to protect its rights, and at this point. The ANDA review process is just beginning and the realisation of generic competition is neither certain, nor imminent.
In early 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 FDA in June 2003. 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's Has challenged innovator’s ‘950, ‘194, ‘867 and ‘732 patents listed in the Orange Book.
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 barrier.
Importantly, Wockhardt is first Para IV filer on Entacapone tablets (Comtan) and innovator Orion sued Wockhardt for in the District Court of Delaware. The case is pending in the Delaware district court, US, and may come up for hearing in November 2009. Sun Pharma also had challenged the patent on Comtan's 200 mg version.
USFDA approved Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) NDA for 12.5MG;200MG;50MG, 25MG;200MG;100MG and 37.5MG;200MG;150MG strength on Jun 11, 2003.
Recently, USFDA approved new strengths of Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) 50MG;200MG;200MG (approved on Aug 2, 2007), 18.75MG;200MG;75MG (approved on Aug 29, 2008), and 31.25MG;200MG;125MG (approved on Aug 29, 2008)
Earlier news of ip pharmadoc on this product Here
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's Has challenged innovator’s ‘950, ‘194, ‘867 and ‘732 patents listed in the Orange Book.
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 barrier.
Importantly, Wockhardt is first Para IV filer on Entacapone tablets (Comtan) and innovator Orion sued Wockhardt for in the District Court of Delaware. The case is pending in the Delaware district court, US, and may come up for hearing in November 2009. Sun Pharma also had challenged the patent on Comtan's 200 mg version.
USFDA approved Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) NDA for 12.5MG;200MG;50MG, 25MG;200MG;100MG and 37.5MG;200MG;150MG strength on Jun 11, 2003.
Recently, USFDA approved new strengths of Stalevo (CARBIDOPA; ENTACAPONE; LEVODOPA) 50MG;200MG;200MG (approved on Aug 2, 2007), 18.75MG;200MG;75MG (approved on Aug 29, 2008), and 31.25MG;200MG;125MG (approved on Aug 29, 2008)
Earlier news of ip pharmadoc on this product Here
Link to Business standard News
No comments:
Post a Comment