Which company holds keytruda's patents?

Who owns the patents for Keytruda?

The patents for Keytruda (pembrolizumab) are owned by Merck & Co., Inc. [1] In 2014, the U.S. Food and Drug Administration (FDA) approved Keytruda as a treatment for metastatic melanoma, and the product has since gained additional approvals for use in other cancers, including non-small cell lung cancer and head and neck cancer.

What role do patents play in Keytruda's exclusivity?

Patents provide Merck & Co. with exclusive rights to manufacture and sell Keytruda for a certain period, typically 20 years from the initial patent filing date. According to DrugPatentWatch.com [2], several Keytruda patents are scheduled to expire in the mid-2020s.

How do biosimilars relate to Keytruda's patents?

Biosimilars are similar versions of biologic medications, including immunotherapies like Keytruda. To enter the market, biosimilars must meet specific requirements and demonstrate similarity in efficacy and safety to the original product. Merck & Co. has been vigilant in enforcing its patents related to Keytruda, and the company has pursued litigation against biosimilar applicants to protect its intellectual property.

Exclusivity expiry timeline

Keytruda's patent exclusivity is expected to expire in various countries at different times. In the United States, the key patent for Keytruda expires in 2025. The expiration dates for patents in other countries, including in the European Union and Japan, vary depending on the specific patent and jurisdiction.

References:
[1] Merck & Co., Inc. (2023). Pembrolizumab (Keytruda) - Patent Information.
[2] DrugPatentWatch.com (2023). Pembrolizumab (Keytruda) - Expiration Date.