Case Study: Pfizer’s Lyrica’s patent extension with paediatric exclusivity

USFDA granted 6-month pediatric exclusivity to Lyrica, which helps to Lyrica to extent the patent expiration by additional 6 month.

Lyrica received paediatric exclusivity after Pfizer tested its drug in patients with pediatric epilepsy; the drug succeeded in a phase 3 trial in the patient group back in May. Along with its indications to treat fibromyalgia and pain from certain causes, Lyrica is also approved as an adjunctive therapy to treat partial onset seizures in patients four years and older.

LYRICA is currently approved in the U.S. for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. LYRICA is also approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.