Which pharmaceutical companies make nivolumab?

Who manufactures nivolumab?

Bristol-Myers Squibb (BMS) manufactures nivolumab under the brand name Opdivo. BMS developed the drug and still holds the primary responsibility for its production and marketing.

Who holds the rights outside the United States?

BMS partnered with Ono Pharmaceutical in Japan, where Ono holds co-development and co-commercialization rights. In the rest of Asia, Korea, Taiwan, and Australia, Ono has exclusive rights.

Why are companies challenging this patent?

Several generic and biosimilar developers have filed Paragraph IV certifications against BMS patents covering nivolumab. These challenges focus mainly on patents with expiration dates between 2027 and 2033.