Wednesday, January 2, 2008

Sun files Para IV against Entacapone product patent

Sun Pharma informed Orion Corporation that it has amended its Abbreviated New Drug Application (ANDA) with the USFDA seeking authorisation to produce and market generic versions of Stalevo tablets 25/100/200 mg and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone in the United States. Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's US5446194, which covers N,N-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)acrylamide as product (Entacapone) generically as well as specifically. 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
The ANDA review process has recently just begun and the realisation of generic competition is neither certain nor imminent. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease.
Sun previously filed Paragraph IV certifications against Orion's U.S. Patents US6500867 and US6797732, and Orion subsequently sued Sun (November 2007) in the United States for patent infringement. Of the six Orion patents listed in the FDA's Orange Book, three have not received Paragraph IV certifications from Sun (US4,963,590, US5,112,861, and US5,135,950), and the latest of these expires 31 October 2010. Paragraph IV certifications are not uncommon in the USA. Orion is, together with Novartis, currently evaluating its legal options to protect its rights. Under the U.S. system, if a patent owner brings a lawsuit against an ANDA applicant within a certain time limit, there will be a 30-month stay of final FDA approval. During that time, the FDA can give only a tentative approval to the ANDA applicant unless the applicant obtains a favorable decision on all challenged patents in the lawsuit India (Sun), has amended its Abbreviated New Drug Application (ANDA) with the USFDA seeking authorisation to produce and market generic versions of Stalevo tablets 25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone in the United States. Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's US 5446194. The ANDA review process has recently just begun and the realisation of generic competition is neither certain nor imminent. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. Sun previously filed Paragraph IV certifications against Orion's U.S. Patents US6500867 and US6797732, and Orion subsequently sued Sun (November 2007) in the United States for patent infringement. Of the six Orion patents listed in the FDA's Orange Book, three have not received Paragraph IV certifications from Sun (US4,963,590, US5,112,861, and US5,135,950), and the latest of these expires 31 October 2010

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