How much time is left on opdivo's patent?

What is the current patent status of Opdivo?

Opdivo, also known as nivolumab, is a medication developed by Bristol-Myers Squibb (BMS) for the treatment of various types of cancer, including melanoma, lung cancer, and kidney cancer [1]. The patent for Opdivo is scheduled to expire on May 28, 2036, in the United States.

How long does BMS have left to maintain exclusivity?

According to the U.S. Food and Drug Administration (FDA) and the Orange Book, which publishes information on FDA-approved pharmaceuticals, Opdivo's patents will expire in different years in various countries.

* In the United States, the patent for nivolumab will expire on May 28, 2036, for its original use in treating melanoma and kidney cancer.
* In Japan, the patent for nivolumab will expire on April 12, 2036.
* In Europe, the patent for nivolumab will expire on May 29, 2036.

Can biosimilars enter the market before patent expiry?

Under current regulations, biosimilars, also known as biologics, cannot enter the market before the patent for the original biologic expires. Biosimilars are medications that mimic the effects of an existing biologic but are not produced through the traditional fermentation or cell culture methods used for biologics. They are generally less expensive and often have a faster development timeline than their biologic counterparts.

However, there are exceptions when a biosimilar sponsor believes that the reference biologic is off-patent or that the patent for the biologic has expired [2]. If a court rules that a patent for a biologic is invalid or does not cover the specific biosimilar in question, the biosimilar can enter the market before the original biologic's patent expires.

Keep in mind that the timeline may change, and future updates or rulings could affect the availability of biosimilars or generic alternatives for nivolumab.

References:

[1] Bristol-Myers Squibb, (n.d.). Opdivo (nivolumab) injection, for intravenous use [Package insert].

[2] Food and Drug Administration, (2022). Biosimilars Approvals. Retrieved from https://www.fda.gov/drugs/development-approval-process/drugs/biosimilars-approvals

Sources:
(1) https://www.drugpatentwatch.com/drug/Opdivo
(2) https://www.fda.gov/drugs/development-approval-process/drugs/biosimilars-approvals
(3) https://www.drugs.com/opdivo.html