The decision by a US court to invalidate four patents related to Ampyra (dalfampridine) last year, came as a major blow to Acorda Therapeutics, a biotech based in New York.
According to the company’s Q2 financials, the product generated sales of $150m (€129m) in the second quarter, with this representing an overwhelming chunk of the company’s total revenue of $153m.
Ampyra is used to treat patients with multiple sclerosis, particularly helping to improve walking speed.
However, after its four patents were invalidated, it looked likely that generic competitors could enter the market.
In the short-term, this now looks unlikely, after the company struck an agreement with three potential competitors to delay the release of generics.
The agreement with Mylan sees generic competition staved off until 2025, unless “certain circumstances” arise, which could then see its generic arrive earlier.
Teva has also agreed to delay until August 31, 2018, and with Hikma Pharmaceuticals until the Federal Circuit releases a decision on Acorda’s appeal against the patent ruling.
Acorda revealed that it maintains guidance of net revenue from the product to reach $330-350m by the end of the financial year.
The company now awaits a decision on another product that could make up for any shortfall in revenue from generic competition to Ampyra. Its product Inbrija (levodopa) has overcome regulatory issues, with the company’s new drug application accepted by the US Food and Drug Administration – a decision is due on the product by October 2018.