Pharsight

Stivarga is owned by Bayer Hlthcare.

Stivarga contains Regorafenib.

Stivarga has a total of 5 drug patents out of which 1 drug patent has expired.

Expired drug patents of Stivarga are:

US7351834

Stivarga was authorised for market use on 27 September, 2012.

Stivarga is available in tablet;oral dosage forms.

Stivarga can be used as 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 kinase inhibitor.

The generics of Stivarga are possible to be released after 09 July, 2032.

Application	Filing Date	Opposition Party	Legal Status
EP07818583A	2014-03-18	Fresenius Kabi Deutschland GmbH	Opposition rejected

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US8637553	July, 2016	Terminated-Denied	Bayer HealthCare LLC	Fustibal LLC
US9957232	November, 2015	Decision	Alfons Grunenberg et al

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7351834	BAYER HLTHCARE	ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors	Jun, 2022 (8 months ago)
US8637553	BAYER HLTHCARE	Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions	Feb, 2031 (7 years from now)
US9957232	BAYER HLTHCARE	4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate	Jul, 2032 (9 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8680124	BAYER HLTHCARE	Treatment of cancers with acquired resistance to kit inhibitors	Jun, 2030 (7 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 (8 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Apr 27, 2024

Drugs and Companies using REGORAFENIB ingredient

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 kinase inhibitor

Dosage: TABLET;ORAL