When Does Onpattro's Exclusivity Expire?
The Onpattro (patisiran) patent, held by Alnylam Pharmaceuticals, Inc., [1] is a key concern for companies seeking to develop and market similar treatments for transthyretin-mediated amyloidosis (ATTR). According to DrugPatentWatch.com, the Onpattro patent (US Patent No. 11,006,955B2) expires on August 1, 2032, in the United States [2].
What Happens If Biosimilars Enter the Market Before Exclusivity Expires?
Biosimilars are biologically equivalent versions of branded prescription drugs. If biosimilars enter the market before Onpattro's exclusivity expires, it could lead to increased competition and reduced prices for the drug. Alnylam's patent protection, however, would still be in place, allowing the company to potentially block generic or biosimilar versions of Onpattro from entering the market.
Why Are Companies Challenging the Onpattro Patent?
Companies like Akcea Therapeutics, Inc. (a subsidiary of Ionis Pharmaceuticals, Inc.) and PTC Therapeutics, Inc. have developed their own treatments for ATTR, which may infringe on Onpattro's patent. These companies might challenge the patent in order to gain access to the marketplace and offer competing products.
Can Biosimilars Enter the Market After Exclusivity Expires?
Yes, biosimilars can enter the market after Onpattro's exclusivity expires. In the United States, biosimilars are approved by the Food and Drug Administration (FDA) and are considered interchangeable with the original branded product. After exclusivity expires, biosimilars can be developed and marketed by multiple companies, leading to increased competition and reduced prices.
Patient Concerns About Onpattro
Patients with ATTR may be concerned about the availability and affordability of Onpattro and other treatments for their condition. As the Onpattro patent approaches expiration, patients may be wondering whether biosimilars will be available and whether they will be cost-effective.
Sources:
[1] Alnylam Pharmaceuticals, Inc. (2022). Onpattro (patisiran) Prescribing Information.
[2] DrugPatentWatch.com. (2022). Patented medications in the United States, retrieved from https://www.drugpatentwatch.com/patents/11006955B2
Please note that the above information is current as of December 2023 and subject to change. For the most up-to-date information, please check the latest sources.