Generic Stivarga Availability
Last updated on Oct 9, 2024.
Stivarga is a brand name of regorafenib, approved by the FDA in the following formulation(s):
STIVARGA (regorafenib - tablet;oral)
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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: Generic Drug FAQ.
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.
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Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Patent 8,637,553
Issued: January 28, 2014
Inventor(s): Boyer Stephen & Dumas Jacques & Riedl Bernd & Wilhelm Scott
Assignee(s): Bayer Healthcare LLCA compound of Formula (I):
Patent expiration dates:
- February 16, 2031✓✓
- February 16, 2031
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Treatment of cancers with acquired resistance to kit inhibitors
Patent 8,680,124
Issued: March 25, 2014
Inventor(s): Wilhelm Scott & Gedrich Richard W.
Assignee(s): Bayer Healthcare LLCThe 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✓
- June 2, 2030
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Patent 9,458,107
Issued: October 4, 2016
Inventor(s): Stiehl Juergen & Heilmann Werner & Lögers Michael & Rehse Joachim & Gottfried Michael & Wichmann Saskia
Assignee(s): BAYER INTELLECTUAL PROPERTY GMBHThe 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✓
- April 8, 2031
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4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate
Patent 9,957,232
Issued: May 1, 2018
Inventor(s): Grunenberg Alfons & Stiehl Juergen & Tenbieg Katharina & Keil Birgit
Assignee(s): BAYER HEALTHCARE LLCThe present invention relates to 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate, to processes for its preparation, to pharmaceutical compositions comprising it and to its use in the control of disorders.
Patent expiration dates:
- July 9, 2032✓
- July 9, 2032
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:
- April 27, 2024 - TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC OR LIVER CANCER) WHO HAVE BEEN PREVIOUSLY TREATED WITH THE DRUG SORAFENIB.
More about Stivarga (regorafenib)
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- During pregnancy
- FDA approval history
- Drug class: multikinase inhibitors
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A 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 Exclusivity | Exclusivity 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. |
| RLD | A 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
