Orion Corporation filed a patent infringement lawsuit (press release Here) in the United States to enforce its US5,446,194 (which covers Entacapone as product) against Sun Pharma Global, Inc., who seeks to market a generic version of Orion Corporation's proprietary drug, Comtan® in the United States. Comtan contains Entacapone and is a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis.
As reported earlier by IPPharmadoc Here, Orion Corporation was notified that Sun Pharma Global had submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge of Orion Corporation's '194 patent. By suing to enforce its patent within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving Sun Pharma Global's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patent in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan.
As reported earlier by IPPharmadoc Here, Orion Corporation was notified that Sun Pharma Global had submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge of Orion Corporation's '194 patent. By suing to enforce its patent within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving Sun Pharma Global's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patent in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan.
Also, Innovator has already sued first para IV filed Wockhardt for this product
No comments:
Post a Comment