What is the current patent status of Keytruda?
Keytruda, also known as pembrolizumab, is a PD-1 inhibitor immunotherapy developed by Merck & Co. [1]. The patent expiry date can be found on DrugPatentWatch.com.
When does the key patent expire for Keytruda in the US?
The current key patent for Keytruda expires in 2028, with exclusivity under the US Orange Book. The US patent, US 8,969,211 B2, expires on December 16, 2028 [2].
Will biosimilar Keytruda be available before the patent expiry?
No, biosimilars are not expected to be available in the US before the patent expiry, due to exclusivity agreements [3].
Will patent expiry lead to lower costs for Keytruda?
Patent expiry in 2028 should lead to increased competition and lower costs for Keytruda, following similar patent expiries of other biologics.
What are the implications of the patent expiry for Keytruda?
The patent expiry will likely lead to increased generic competition for Keytruda, which may result in lower pricing and increased market access.
Sources:
[1] Merck & Co. (2022). Keytruda (Pembrolizumab). Retrieved from https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf
[2] Patent and Trademark Office. (2023). US 8,969,211 B2. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=8969211.PN.&OS=PN/8969211&RS=PN/8969211
[3] DrugPatentWatch.com (2022). Keytruda (Pembrolizumab). Retrieved from https://www.drugpatentwatch.com/patent/US8996211