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Generic Stivarga Availability

Stivarga is a brand name of regorafenib, approved by the FDA in the following formulation(s):

STIVARGA (regorafenib - tablet;oral)

  • Manufacturer: BAYER HLTHCARE
    Approval date: September 27, 2012
    Strength(s): 40MG [RLD]

Has a generic version of Stivarga been approved?

No. There is currently no therapeutically equivalent version of Stivarga available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Stivarga. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
    Patent 7,351,834
    Issued: April 1, 2008
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday & Lowinger; Timothy & Scott; William & Smith; Roger A. & Wood; Jill E. & Monahan; Mary-Katherine & Natero; Reina & Renick; Joel & Sibley; Robert
    Assignee(s): Bayer Pharmaceuticals Corporation
    This invention relates to the use of a group of aryl ureas in treating raf mediated diseases, and pharmaceutical compositions for use in such therapy.
    Patent expiration dates:
    • January 12, 2020
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      Drug substance
  • Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
    Patent 8,637,553
    Issued: January 28, 2014
    Assignee(s): Bayer Healthcare LLC
    A compound of Formula (I): salts thereof, prodrugs thereof, metabolites thereof, pharmaceutical compositions containing such a compound, and use of such compound and compositions to treat diseases mediated by raf, VEGFR, PDGFR, p38 and flt-3.
    Patent expiration dates:
    • February 16, 2031
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      Drug substance
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      Drug product
  • Treatment of cancers with acquired resistance to kit inhibitors
    Patent 8,680,124
    Issued: March 25, 2014
    Assignee(s): Bayer Healthcare LLC
    The present invention provides compositions and uses thereof for treating cancers which have acquired resistance to a KIT inhibitor by administering effective amounts of DAST (4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide).
    Patent expiration dates:
    • June 2, 2030
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      Patent use: 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
  • Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-ethylpyridie-carboxamide, its salts and monohydrate
    Patent 9,458,107
    Issued: October 4, 2016
    Assignee(s): BAYER INTELLECTUAL PROPERTY GMBH
    The present invention relates to a process for preparing 4-(4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorophenoxy)-N-methylpyridine-2-carboxamide, its salts and monohydrate.
    Patent expiration dates:
    • April 8, 2031
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • February 25, 2016 - TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH IMATINIB MESYLATE AND SUNITINIB MALATE
    • September 27, 2017 - NEW CHEMICAL ENTITY
    • February 25, 2020 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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