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Generic Nexavar Availability

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

NEXAVAR (sorafenib tosylate - tablet;oral)

  • Manufacturer: BAYER HLTHCARE
    Approval date: December 20, 2005
    Strength(s): EQ 200MG BASE [RLD]

Has a generic version of Nexavar been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nexavar. 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.

  • Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
    Patent 7,235,576
    Issued: June 26, 2007
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday & Lowinger; Timothy B. & Scott; William J. & Smith; Roger A. & Wood; Jill E. & Monahan; Mary-Katherine & Natero; Reina & Renick; Joel & Sibley; Robert N.
    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
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  • 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
  • ω-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors
    Patent 7,897,623
    Issued: March 1, 2011
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday R. & Lowinger; Timothy B. & Scott; William J. & Smith; Roger A. & Wood; Jill E. & Monahan; Mary-Katherine & Natero; Reina & Renick; Joel & Sibley; Robert N.
    Assignee(s): Bayer Healthcare LLC
    This invention relates to the use of a group of aryl ureas in treating p38 mediated diseases, and pharmaceutical compositions for use in such therapy.
    Patent expiration dates:
    • January 12, 2020
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      Drug product
  • ω-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
    Patent 8,124,630
    Issued: February 28, 2012
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday & Lowinger; Timothy B. & Scott; William J. & Smith; Roger A. & Wood; Jill E. & Natero; Reina
    Assignee(s): Bayer Healthcare LLC
    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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      Patent use: TREATMENT OF CARCINOMA OF THE THYROID
  • Aryl ureas with angiogenesis inhibiting activity
    Patent 8,618,141
    Issued: December 31, 2013
    Assignee(s): Bayer Healthcare LLC
    This invention relates to methods of using aryl ureas to treat diseases mediated by the VEGF induced signal transduction pathway characterized by abnormal angiogenesis or hyperpermeability processes.
    Patent expiration dates:
    • February 11, 2023
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      Patent use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA
  • Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
    Patent 8,841,330
    Issued: September 23, 2014
    Assignee(s): Bayer Healthcare LLC
    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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      Patent use: TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
  • Thermodynamically stable form of a tosylate salt
    Patent 8,877,933
    Issued: November 4, 2014
    Assignee(s): Bayer Intellectual Property GmbH
    The present invention relates to a novel form, thermodynamically stable at room temperature, of the tosylate salt of 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide, to processes for its preparation, to medicaments comprising it and to its use in the control of disorders.
    Patent expiration dates:
    • December 24, 2027
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      Patent use: TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA, OR DIFFERENTIATED THYROID CARCINOMA.
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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:
    • November 22, 2016 - TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA (DTC) THAT IS REFRACTORY TO RADIOCACTIVE IODINE TREATMENT
    • November 22, 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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