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Brazil approves first generic semaglutide pen after Ozempic patent expiry

FILE PHOTO: A general view of the Brazilian health regulator Anvisa headquarters in Brasilia, Brazil February 23, 2021. REUTERS/Ueslei Marcelino/ File Photo
FILE PHOTO: A general view of the Brazilian health regulator Anvisa headquarters in Brasilia, Brazil February 23, 2021. REUTERS/Ueslei Marcelino/ File Photo Reuters

SAO PAULO - Brazil's health regulator Anvisa said on Tuesday it had approved EMS's Ozivy, the country's first semaglutide-based injector pen, as the drugmaker looks to expand into a higher-end segment of the global pharmaceutical industry.

The drug uses the same active ingredient as Novo Nordisk's diabetes and weight-loss ​drug Ozempic, whose patent expired in Brazil in March.

• Drug to be produced at EMS plant in Sao Paulo state with capacity for up to 40 million pens per year.

• CEO of Grupo NC, which controls EMS, told Reuters in March the firm expected to launch semaglutide pens this year.

• Following the registration, the drug will be marketed once Brazil's medicine pricing chamber approves a price cap.

• For inclusion in Brazil's public healthcare system SUS, Ozivy must be approved by the Health Ministry.

• Five other synthetic semaglutide applications and one biological version are under review by Anvisa.

• EMS rival Hypera had previously said it also planned to launch its generic version of semaglutide this year.

(Reporting by Isabel Teles and Gabriel Araujo; Editing by Paul Simao)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published May 26, 2026 at 11:47 AM.

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