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Surprise! Viatris Proves Its Worth With First Generic Restasis Approval

Complex Legal History And Development Challenges Surrounded Brand

 
• By Dean Rudge

In one of the most keenly-watched markets, Viatris has emerged as the winner of approval for the first US generic version of AbbVie’s Restasis 0.05% ophthalmic emulsion, years after its IP was taken down. Numerous firms and analysts had acknowledged the complexity of the reference brand.

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AbbVie's dry eye brand finally has an approved generic • Source: Alamy

Approaching five years since its intellectual property was invalidated, AbbVie’s Restasis (cyclosporine) 0.05% ophthalmic emulsion finally has approved generic competition, drawing a line under one of the most controversial legal affairs in recent US pharma history.

Viatris’Mylan has won US Food and Drug Administration approval for its generic version of

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