The DMF filing upto Sep 30, 2016 is out and Shilpa has filed one DMF during the quarter (Q3CY16).
Pirfenidone (gEsbriet):
- Innovator: Genentech (Roche Group) - www.esbriet.com
- Medicine for the treatment of idiopathic pulmonary fibrosis (IPF).
- The IPF market is currently dominated by only two drugs – Roche’s Esbriet & Boehringer Ingelheim’s Ofev.
- The top-selling drug in IPF in value terms is Roche’s Esbriet, which GlobalData estimates generated ~$572m in 2015.
- Esbriet has been retailing in US at ~8200USD for 270 capsules; stable price since past 2 years.
- Exclusivity expiry: 2019-10-16
- Other DMF filers: Signa, Honour Lab, Lupin and Granules. Last two filed in 2016.