Unique formulation of Oseltamivir by BIOFARM

26 Jul 2019

BIOFARM Poland has been granted a patent for its own innovative formulation of tablets containing oseltamivir phosphate. Due to the unique, high concentration of the active substance, BIOFARM’s tablets are significantly smaller.

OSELTAMIVIR BIOFARM is a pharmaceutical product containing oseltamivir phosphate (75 mg). BIOFARM, a pharmaceutical manufacturer from Poland, has been granted a patent for its own innovative formulation (PL396648).

Unique formulation of Oseltamivir by BIOFARM

Due to the unique, high concentration of the active substance, BIOFARM’s tablets are significantly smaller than the originator’s capsules.

The dossier developed by BIOFARM is in eCTD format, with valid bioequivalence studies confirming that OSELTAMIVIR BIOFARM is bioequivalent with the reference product.

Formulations containing oseltamivir phosphate are an effective medicine for treating people with influenza symptoms and prevention for people who have recently had contact with the infected, especially during an epidemic or pandemic.

Key dates on patent protection:

  • 26 February 2016: molecule protection in European Union (patent EP0759917) expired,

  • 20 June 2017: Supplementary Protection Certificate expired,

  • 22 August 2017: oseltamivir phosphate protection (patent EP0920410) expired
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