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Alvogen and business partners obtain first European approvals for generic Ulipristal 5mg

08 April 2019

Alvogen today announced that it has successfully concluded sixteen parallel registration procedures for Ulipristal tablets. Alvogen and its business partners have received regulatory clearance for its product in multiple European countries. Alvogen, together with its business partner, is the first company in Europe to obtain approval. Scientific approval has been obtained for Ulipristal 5 mg tablets.

Alvogen's product is a generic and bioequivalent version of Esmya®* tablets and has been fully developed in house by Lotus pharmaceuticals, an Alvogen subsidiary. Alvogen and its business partners have filed for marketing authorization in 16 European countries using 16 decentralized procedures.

Esmya® is a drug indicated for the treatment of uterine fibroids. The product was developed by Lotus pharmaceuticals, an Alvogen affiliate and is part of a comprehensive portfolio developed and licensed out to multiple leading business partners worldwide.

“We are pleased with the approval for generic Ulipristal tablets, and we look forward, with our business partners, to leading the commercialization of this important product in Europe. Alvogen has a promising pipeline of in-house generic projects and pending regulatory applications across its technological platforms of complex generics including oral oncology portfolio, hormones, soft gels and value-added generics.”

Faysal Kalmoua

Executive Vice President of Alvogen’s Global Portfolio