U.S. FDA approves first generic version of AbbVie's dry-eye drug

A sign stands outside a Abbvie facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder

Feb 2 (Reuters) - The U.S. health regulator said on Wednesday that it had approved the first generic version of AbbVie Inc's (ABBV.N) Restasis, a treatment used in increasing tear production in patients with dry-eye syndrome.

The approval was granted to Viatris Inc (VTRS.O), which was formed through the merger of generic drugmaker Mylan Pharmaceuticals and Pfizer Inc's (PFE.N) off-patent drug business in 2020.

AbbVie acquired Restasis, which was approved in the United States nearly two decades ago,through its $63 billion acquisition of Allergan Inc in 2020.

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Allergan had sought to shield the drug's patents from a federal administrative court's review by transferring them to a Native American tribe in 2017. The bid was subsequently rejected by the Supreme Court in 2019.

Restasis generated revenue of $1.29 billion for AbbVie in 2021, a 64% jump from a year earlier. Analysts are expecting the drug to bring in revenue of $655.6 million in 2022, according to Refinitiv IBES data.

The drug is an immunosuppressive medicine, which works to increase tear production by helping reduce inflammation associated with dry eye.

AbbVie and Viatris did not immediately respond to Reuters' requests for comment.

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Reporting by Amruta Khandekar; Editing by Krishna Chandra Eluri and Anil D'Silva

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