Generic Zelboraf Availability

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

ZELBORAF (vemurafenib - tablet;oral)

  • Manufacturer: HOFFMANN LA ROCHE
    Approval date: August 17, 2011
    Strength(s): 240MG [RLD]

Has a generic version of Zelboraf been approved?

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

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

  • Compounds and methods for development of Ret modulators
    Patent 7,504,509
    Issued: March 17, 2009
    Inventor(s): Ibrahim; Prabha & Artis; Dean Richard & Bremer; Ryan & Habets; Gaston & Hurt; Clarence R. & Mamo; Shumeye & Nespi; Marika & Zhang; Chao & Zhang; Jiazhong & Zhu; Yong & Zuckerman; Rebecca & Krupka; Heike & Kumar; Abhinav & West; Brian
    Assignee(s): Plexxikon, Inc.
    Compounds active on Ret are described, as well as methods of using such compounds. Also described are crystal structures of Ret surrogates that were determined using X-ray crystallography. The use of such Ret surrogate crystals and structural information can, for example, be used for identifying molecular scaffolds and for developing ligands that bind to and modulate Ret and for identifying improved ligands based on known ligands.
    Patent expiration dates:
    • October 22, 2026
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      Drug substance
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      Drug product
  • Compounds and methods for kinase modulation, and indications therefor
    Patent 7,863,288
    Issued: January 4, 2011
    Inventor(s): Ibrahim; Prabha N. & Artis; Dean R. & Bremer; Ryan & Mamo; Shumeye & Zhang; Chao & Zhang; Jiazhong & Tsai; James & Hirth; Klaus-Peter & Bollag; Gideon & Spevak; Wayne & Cho; Hanna & Gillette; Samuel J. & Shi; Shenghua
    Assignee(s): Plexxikon, Inc.
    Compounds active on protein kinases are described, as well as methods of using such compounds to treat diseases and conditions associated with aberrant activity of protein kinases.
    Patent expiration dates:
    • June 20, 2029
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      Drug substance
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      Drug product
  • Compounds and methods for kinase modulation, and indications therefor
    Patent 8,143,271
    Issued: March 27, 2012
    Inventor(s): Ibrahim; Prabha N. & Artis; Dean R. & Bremer; Ryan & Zhang; Chao & Zhang; Jiazhong & Tsai; James & Hirth; Klaus-Peter & Bollag; Gideon & Cho; Hanna
    Assignee(s): Plexxikon Inc.
    Compounds active on protein kinases are described, as well as methods of using such compounds to treat diseases and conditions associated with aberrant activity of protein kinases.
    Patent expiration dates:
    • June 21, 2026
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      Drug substance
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      Drug product
  • Compounds and methods for kinase modulation, and indications therefor
    Patent 8,470,818
    Issued: June 25, 2013
    Assignee(s): Plexxikon Inc.
    Compounds active on protein kinases are described, as well as methods of using such compounds to treat diseases and conditions associated with aberrant activity of protein kinases.
    Patent expiration dates:
    • August 2, 2026
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      Patent use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E MUTATION AS DETECTED BY AN FDA APPROVED TEST

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:
    • August 17, 2016 -
    • August 17, 2018 -

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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