FAS opens antitrust case against Grotex over early generic launch

The Federal Antimonopoly Service has opened a case against the company

Consensus

• FAS has opened an antitrust investigation into company 'Grotex'.
• The company introduced the generic drug 'Emporiks' into circulation before the patent on the original drug expired.
• The original drug is 'Jardiance', which contains the active ingredient empagliflozine.
• The patent on the original drug expires in November 2029.
• The generic drug 'Emporiks' contains the same active ingredient as the original.
• Grotex did not obtain consent from the patent holder to produce and sell the generic.
• FAS is checking whether Grotex's actions comply with competition protection laws.

Points of divergence

• The company 'Grotex' is the subject of the case, and the patent holder is 'Beringer Ingelheim'. — kommersant
• The patent holder is 'Boehringer Ingelheim International GmbH', and the original drug is produced by 'Boehringer Ingelheim Pharm GmbH & Co.' — interfax
• Grotex operates under the brand Solopharm, and the patent holder is represented by 'Beringer Ingelheim' and 'Beringer Ingelheim Pharm GmbH & Co.'. Also mentions a separate case against 'Ferment' company regarding pricing of 'Bifiliz'. — vedomosti

Coverage (3 sources)

• FAS opened a case on the sale of a generic before the expiration of the patent on the original — Коммерсантъ
• FAS opened a case on the introduction of a generic before the expiration of the patent term — Интерфакс
• FAS launched an antimonopoly case against the pharmaceutical company — Ведомости

Key entities

• FAS
• Groteks
• Moscow
• INTERFAX.RU
• Russia
• Federal Antimonopoly Service
• Solopharm
• Beringer Ingelheim LLC
• Emforix
• Boehringer Ingelheim
• Bayering Pharma