Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Patent and Trademark Office (USPTO) has determined that U.S. Patent No. 5,540,938 (“the ‘938 patent”) is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act. The claims of the ‘938 patent relate to methods for treating a neurological disease, such as multiple sclerosis (MS), and cover the use of a sustained release dalfampridine formulation, such as AMPYRA
(dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. With a five year patent term extension, the ‘938 patent would expire in 2018.
Acorda also has a granted U.S. patent and an allowed U.S. patent application covering the use of AMPYRA in improving walking in people with MS. The granted U.S. patent will expire in 2027, and the allowed U.S. patent application, once granted, is expected to expire in 2025 plus any additional term determined by the USPTO based on patent term adjustment provisions.
AMPYRA is approved by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with MS. This was demonstrated by an improvement in walking speed.
Important Safety Information
Do not take AMPYRA if you have ever had a seizure or have certain types of kidney problems.
Take AMPYRA exactly as prescribed by your doctor.
You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50.
Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking AMPYRA.
AMPYRA may cause serious allergic reactions, including rare occurrence of anaphylaxis.