Acorda Therapeutics, Inc.’s ACOR shares gained almost 7% after the U.S. Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld four patents of its key growth driver, Ampyra.
Acorda holds five Orange Book listed patents for Ampyra that run until 2027.
The four U.S. patents upheld include 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent), which are set to expire in 2025, 2025, 2026 and 2027, respectively.
Meanwhile, inter partes review (IPR) petitions challenging U.S. ’938 patent that also pertain to Ampyra have been filed in the U.S. District Court for the District of Delaware. The Court has completed the trial of the case but has not yet announced its decision.
We note that Acorda is facing patent challenges for Ampyra is the U.S. A total of ten generic drug manufacturers have submitted abbreviated new drug applications (ANDA), with the FDA seeking marketing approval for generic versions of Amypra. In 2015 and 2016, Acorda reached settlement agreements with six of the generic companies including Allergan plc AGN. The patent infringement case against Mylan N.V. MYL, however, is still proceeding in Delaware alongside cases against other ANDA filers.
Ampyra is Acorda’s flagship product, which is currently approved in the U.S. for the improvement of walking in multiple sclerosis patients. It is available outside the U.S. under the trade name Fampyra. The drug registered sales of $492.8 million in 2016, reflecting an increase of 12.8%. Acorda has a licensing agreement with Biogen BIIB for Fampyra in markets outside the U.S.
Currently, Acorda is working on expanding Ampyra’s label into additional indications.
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