Generic Dalfampridine Tablet Marketed for Patients With MS
Mylan’s new Dalfampridine Extended-Release Tablets, 10 mg, an authorized generic version of Acorda's Ampyra® is being marketed to treat adult patients with multiple sclerosis.
Mylan has launched its 10 mg Dalfampridine Extended-Release Tablets, an authorized generic version of Acorda's Ampyra (dalfampridine).1 Dalfampridine, which is being marketed to to treat adult patients with multiple sclerosis (MS), is indicated to improve patients’ ability to walk and increase speed.1-2
In a prepared statement, Mylan CEO Heather Bresch said the availability of the generic product is reflective of the company’s commitment to providing medication access to patients with MS. "Mylan offers 100 products in the area of CNS alone, including 20 of the top CNS products dispensed in the US,” she noted.1
The most common adverse effects associated with the use of Ampyra are urinary tract infection, insomnia, dizziness, headache, nausea, weakness, and back pain.2 Patients who use the drug are also at an increased risk for seizures, according to the FDA.3
Ampyra was approved by the FDA in 2010.3 Additionally, Aurobindo Pharma was granted the agency’s approval in early 2017 for a bioequivilant dalfampridine extended-release tablet (10 mg) product.2
Acorda's patents pertaining to Ampyra have been the focus of an ongoing dispute between the company and other pharmacuetical manufacturers, including Mylan. On September 10, the United States Court of Appeals for the Federal Circuit upheld the United States District Court for the District of Delaware’s decision to invalidate 4 Ampyra patents.1,4
This most recent decision followed the District Court’s ruling on March 31, 2017 that invalidated US Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437 pertaining to Ampyra Extended Release Tablets. Acorda’s U.S. Patent No. 5,540,938, which had been upheld by the District Court, expired on July 30, 2018.1,4
Ron Cohen, MD, Acorda's President and CEO, expressed disappointment in the September 10 ruling.4
“We continue to believe that our Ampyra patents reflected true invention and were valid. We are reviewing the decision and will consider future options, including the possibility of a further appeal,” he said in a prepared statement.4 "“Following the Court’s original decision in 2017, we prepared a contingency plan that we could face generic competition, implementing a comprehensive corporate restructuring and bolstering our balance sheet."
- Mylan Launches Authorized Generic of Ampyra® Tablets [news release]. Hertfordshire, England; September 21, 2018: Mylan website. http://investor.mylan.com/news-releases/news-release-details/mylan-launches-authorized-generic-ampyrar-tablets. Accessed September 21,2018.
- Vermes K. FDA Approves Ampyra Bioequivalent for Multiple Sclerosis. Pharmacy Times website. https://www.pharmacytimes.com/product-news/fda-approves-amprya-bioequivalent-for-multiple-sclerosis/. Published January 28, 2017. Accessed September 21, 2018.
- FDA Drug Safety Communication: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine). FDA website. https://www.fda.gov/Drugs/DrugSafety/ucm312846.htm. Updated January 19, 2016. Accessed September 21, 2018.
- U.S. Court of Appeals for the Federal Circuit Upholds District Court’s Decision to Invalidate AMPYRA® (dalfampridine) Patents [news release]. Ardsley, NY; September 10, 2018: Arcorda Therapeutics website. http://ir.acorda.com/investors/investor-news/investor-news-details/2018/US-Court-of-Appeals-for-the-Federal-Circuit-Upholds-District-Courts-Decision-to-Invalidate-AMPYRA-dalfampridine-Patents/default.aspx. Accessed September 21, 2018.