FDA approves generic for dry-eye treatment Restasis

Viatris (NSDQ:VTRS) has received FDA approval for the first generic of Restasis (cyclosporine ophthalmic emulsion) eye drops.

FDA first approved the drug, which was developed by Allergan, in 2003.

Now marketed by AbbVie (NYSE:ABBV), Restasis sales are on the order of $1.2 billion annually.

AbbVie recently noted in its projections for 2022 that it expected to maintain U.S. exclusivity of the drug.

Although no longer covered by patent protection, “the complex nature of the product” delayed the launch of a generic, wrote Truist analyst Gregory D. Fraser in a briefing note.

Generic Restasis revenue could be “a material sales contributor for VTRS given the size of the market and potential for limited competition,” Fraser said.

To attempt to discourage generic competition tied to Restasis, Allergan transferred six patents related to the drug to the St. Regis tribe of the Mohawk people in 2017. Allergan made an upfront payment of $13.75 mi…

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