Pirfenidone

Overview

Pirfenidone is a pyridine derivative with antifibrotic properties used to treat idiopathic pulmonary fibrosis by reducing lung fibrosis through modulation of the cytokine cascade. It is believed to exert its therapeutic effects by inhibiting TGF-beta and collagen synthesis and decreasing fibroblast proliferation.

API suppliers (9)

Suppliers of Pirfenidone backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• SIGNA SA DE CV1 active DMF
• SIGNA SA DE CV1 active DMF
• SHILPA PHARMA LIFESCIENCES LTD1 active DMF
• SHILPA PHARMA LIFESCIENCES LTD1 active DMF
• SIGNA SA DE CV1 active DMF
• HONOUR LAB LTD1 active DMF
• Lupin LimitedIndia1 active DMF
• SIGNA SA DE CV1 active DMF
• SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL

Patent & exclusivity (US)

Per the FDA Orange Book (38 approved US products), the latest listed US patent on Pirfenidone expires 28 Mar 2037. Generic API sourcing typically opens up once these lapse.

Therapeutic areas