US Patent Board To Review Mylan's Copaxone Challenge
This article was originally published in Scrip
Executive Summary
The U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings for petitions filed by Mylan against two patents held by Teva on its moneymaker multiple sclerosis drug Copaxone (glatiramer acetate injection).
You may also be interested in...
Mylan Sees A Difference In Having Generic Drug User Fees
FDA is pushing forward with its review of Mylan’s ANDA for generic Advair, according to the company, which is gaining confidence that the application could receive a first round approval. The experience for that application, which has a generic drug user fee, is a clear contrast to the firm's experience with its pre-GDUFA Copaxone filing.
Mylan Confident On Advair Generic First-Round Approval
President Rajiv Malik said there has been “huge movement” at the agency around executing on the first ANDA for a generic version of GlaxoSmithKline’s blockbuster Advair.
Teva Advancing Two Advair Generics With Late 2017 Target
Teva will move forward an internal generic Advair candidate and one acquired from Allergan to improve its chances of getting an interchangeable version of the market-leading asthma drug approved by FDA.