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Natco Pharma Ltd has announced that it has received a successful Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its chemical division in Chennai, named Natco Organics Ltd, prior to amalgamation into the company.
The FDA inspection was conducted during February 8-12, according to a regulatory statement filed with the BSE.
US patent body In another statement to exchanges, Natco Pharma has announced that the US Patent and Trademark Office has ruled in favour of its marketing partner Mylan, in its inter partes review (IPR) proceeding and found all claims of two related Copoxone 40 mg/ml patents to be unpatentable. The US patents owned by Yeda Research & Development Co Ltd were licenced to Teva Pharmaceuticals.
A decision by the PTAB on Mylan’s third party petition seeking inter partes review of US patent is expected on or before September 1.
Natco’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete abbreviated new drug application containing a paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/ml, and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.
Copoxone 40mg/mL had US sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to the IMS health, Natco informed.
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