Regorafenib Patent Expiration

1. Stivarga patent expiration

STIVARGA's oppositions filed in EPO
STIVARGA IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8637553 BAYER HLTHCARE Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Feb, 2031

(6 years from now)

US9957232 BAYER HLTHCARE 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate
Jul, 2032

(7 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7351834 BAYER HLTHCARE ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Jan, 2020

(4 years ago)

US8680124 BAYER HLTHCARE Treatment of cancers with acquired resistance to kit inhibitors
Jun, 2030

(5 years from now)

US9458107 BAYER HLTHCARE Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-ethylpyridie-carboxamide, its salts and monohydrate
Apr, 2031

(6 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-667) Feb 25, 2016
New Chemical Entity Exclusivity(NCE) Sep 27, 2017
Orphan Drug Exclusivity(ODE-44) Feb 25, 2020
Orphan Drug Exclusivity(ODE) Feb 25, 2020
New Indication(I-744) Apr 27, 2020
Orphan Drug Exclusivity(ODE-139) Apr 27, 2024

NCE-1 date: 27 September, 2016

Market Authorisation Date: 27 September, 2012

Treatment: Treatment of patients with gastrointestinal stromal tumor (gist), including but not limited to patients previously treated with imatinib and patients with gist having resistance to a kit tyrosine kina...

Dosage: TABLET

How can I launch a generic of STIVARGA before it's drug patent expiration?
More Information on Dosage

STIVARGA family patents

Family Patents