Keytruda is a brand name for the drug pembrolizumab, which is a humanized monoclonal antibody used to treat various types of cancer. Pembrolizumab was approved by the FDA in 2014 [2].

According to Drug Patent Watch, the first patent for pembrolizumab was filed in 2008, and the last patent is set to expire in 2028 [1]. However, it is important to note that patent exclusivity does not necessarily equate to market exclusivity.

Market exclusivity refers to the period of time during which a drug is protected from competition by generic versions. The FDA grants market exclusivity to drugs that meet certain criteria, such as being the first drug of its kind to be approved for a particular use.

According to the FDA's Orphan Drug Product Designation database, Keytruda has been granted orphan drug exclusivity for several indications, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma [2]. Orphan drug exclusivity lasts for seven years from the date of FDA approval.

In addition to orphan drug exclusivity, Keytruda may also have market exclusivity due to its status as a biologic drug. Biologic drugs are more complex than traditional small molecule drugs, and the FDA grants them a period of exclusivity known as "data exclusivity" or "market exclusivity" [3].

According to FiercePharma, Keytruda's data exclusivity period is set to expire in 2028 [3]. However, it is worth noting that this does not necessarily mean that generic versions of Keytruda will be available at that time, as there are several factors that can affect the availability of generic drugs, including patent litigation and regulatory hurdles.

In summary, Keytruda has been granted orphan drug exclusivity for several indications, which lasts for seven years from the date of FDA approval. It may also have market exclusivity due to its status as a biologic drug, with a data exclusivity period set to expire in 2028. However, it is important to note that patent and market exclusivity do not necessarily equate to the availability of generic versions of the drug.

Sources:
[1] https://www.drugpatentwatch.com/p/biologics/tradename/KEYTRUDA
[2] https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=381012
[3] https://www.fiercepharma.com/special-report/top-15-blockbuster-patent-expirations-coming-decade