When AbbVie came up with its 2022 financial projections and shared them with investors early Wednesday, the company said it expects to retain U.S. exclusivity on blockbuster eye drug Restasis through the first half of the year. After the FDA approved the first generic to the drug that afternoon, those hopes may be dashed.
The FDA has approved Viatris' generic to AbbVie's chronic dry eye treatment Restasis, which generated $1.23 billion in U.S. sales last year. Patents on the drug began expiring in 2014, Viatris' Mylan Pharmaceuticals has noted, but generics haven't been able to pass through the FDA's gate until today despite years of regulatory efforts.
Earlier Wednesday, AbbVie Chief Financial Officer Rob Michael said the company expects $2.9 billion in global eye care sales in 2022. That included a $700 million contribution from Restasis, "which assumes no generic competition in the first half of 2022," Michael said. AbbVie didn't immediately clarify whether the guidance remains intact.
Restasis was at the center of a patent scandal for Allergan before the company's massive sale to AbbVie in 2019. In 2017, Allergan licensed Restasis patents to a Native American tribe in a bid to protect the drug from generic competition. The deal earned the company widespread criticism before its eventual slapdown by the U.S. Supreme Court.
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AbbVie's drug has some patents running through 2024, according to the FDA Orange Book. It isn't clear whether those could block a potential generic launch. A spokesperson for Viatris didn't immediately comment on the company's launch timing.
Despite the controversy and lapsed patents, Restasis has managed to evade copycats for many years. For AbbVie, while a blockbuster's loss of exclusivity isn't a welcome development, the Restasis hit pales in comparison to the massive Humira patent cliff the company expects next year. That drug generated more than $20 billion in 2021 and will start facing U.S. copycats in January 2023.