Generic Inlyta Availability

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

INLYTA (axitinib - tablet;oral)

  • Manufacturer: PFIZER
    Approval date: January 27, 2012
    Strength(s): 1MG, 5MG [RLD]

Has a generic version of Inlyta been approved?

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

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

  • Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
    Patent 6,534,524
    Issued: March 18, 2003
    Inventor(s): Robert Steven; Kania & Steven Lee; Bender & Allen J.; Borchardt & Stephan James; Cripps & Ye; Hua & Michael David; Johnson & Theodore Otto; Johnson, Jr. & Hiep The; Luu & Cynthia Louise; Palmer & Siegfried Heinz; Reich & Anna Marie; Tempczyk-Russell & Min; Teng & Christine; Thom
    Assignee(s): Agouron Pharmaceuticals, Inc.
    Indazole compounds that modulate and/or inhibit the activity of certain protein kinases are described. These compounds and pharmaceutical compositions containing them are capable of mediating tyrosine kinase signal transduction and thereby modulate and/or inhibit unwanted cell proliferation. The invention is also directed to the therapeutic or prophylactic use of pharmaceutical compositions containing such compounds, and to methods of treating cancer and other disease states associated with unwanted angiogenesis and/or cellular proliferation, such as diabetic retinopathy, neovascular glaucoma, rheumatoid arthritis, and psoriasis, by administering effective amounts of such compounds.
    Patent expiration dates:
    • June 30, 2020
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      Drug substance
      ✓ 
      Drug product
  • Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
    Patent 7,141,581
    Issued: November 28, 2006
    Inventor(s): Bender; Steven & Hu-Lowe; Dana & Shalinsky; David Ray
    Assignee(s): Agouron Pharmaceuticals, Inc.
    Indazole compounds that modulate and/or inhibit the activity of certain protein kinases are described. These compounds and pharmaceutical compositions containing them are capable of mediating tyrosine kinase signal transduction and thereby modulate and/or inhibit unwanted cell proliferation. The invention is also directed to the therapeutic or prophylactic use of pharmaceutical compositions containing such compounds, and to methods of treating cancer and other disease states associated with unwanted angiogenesis and/or cellular proliferation, such as diabetic retinopathy, neovascular glaucoma, rheumatoid arthritis, and psoriasis, by administering effective amounts of such compounds.
    Patent expiration dates:
    • June 30, 2020
      ✓ 
      Patent use: TREATMENT OF RENAL CELL CARCINOMA

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:
    • January 27, 2017 - NEW CHEMICAL ENTITY

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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