CATEGORY PRODUCT PROFILE
PRODUCT NAME Pramipexole SR (Sustained Release) Tablet
(Original : Mirapex SR Tablet from Boehringer-Ingelheim)
COMPANY Biopharmartis
DEVELOPMENT
STATUS
Launched in Korea in March, 2014 with the brand name of Mirap SR
(All three strengths : 0.375mg, 0.75mg & 1.5mg)
THERAPEUTIC AREA Parkinson¡¯s Disease
ACTION Dopamine D3 receptor agonist
STRENGTH
  • Diffusion Matrix type SR formulation with identical multi-strength release profile
  • Tablet formulation patent with non-infringement of original formulation patent
  • PCT available (PCT/KR2011/003515)
  • Identical mechanism in simulated gastric fluid compared with original product     (Consider BE test in fed / fasted mode)
  • Simplified manufacturing process = Low manufacturing cost
TECHNOLOGY SR Platform