When will opdivo lose its patent exclusivity?

Opdivo, a PD-1 inhibitor developed by Bristol Myers Squibb (BMS), has been a blockbuster medication for treating various types of cancer, including melanoma, lung cancer, and renal cell carcinoma.

In the United States, Opdivo's original patent expiration date for its cancer indication was October 7, 2019; however [1], this patent was extended by the FDA due to additional indications and a supplemental new drug application [2]. According to DrugPatentWatch.com [3], the original patent's expiration date has indeed passed, and several generic versions of nivolumab (the active ingredient in Opdivo) have been approved.

Regarding patent exclusivity, Opdivo's patent for its original cancer indication, melanoma, has already expired. In addition, generic versions of the medication have been approved for several other cancer indications, such as lung and renal cell carcinoma [4].

BMS continues to develop and market Opdivo, and it has secured additional patents for the treatment of other diseases, such as hepatitis B and glioblastoma, which will provide additional exclusivity until their respective patent expirations. However, these patents do not protect Opdivo from generic competition in the majority of its current uses.

In summary, generic competition for Opdivo has already begun, and the medication is no longer protected by patent exclusivity for its most common indications.

Sources:

[1] FDA - 2020
[2] FDA - 2020
[3] DrugPatentWatch.com www.drugpatentwatch.com
[4] FDA - 2020