FDA approves first generic version of Restasis

3 February 2022

The US Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Restasis is marketed by Allergan, which was acquired by AbbVie (NYSE: ABBV), in a $63 billion deal in 2019. The drug generated full-year 2021 US sales of $1.23 billion. Patents on the drug began expiring in 2014, but Restasis has some patents running through 2024, according to the FDA Orange Book.

Viatris unit sponsored the application

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