Generic Tasigna Availability

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

TASIGNA (nilotinib hydrochloride monohydrate - capsule;oral)

  • Manufacturer: NOVARTIS
    Approval date: October 29, 2007
    Strength(s): EQ 200MG BASE [RLD]
  • Manufacturer: NOVARTIS
    Approval date: June 17, 2010
    Strength(s): EQ 150MG BASE

Has a generic version of Tasigna been approved?

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

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

  • Inhibitors of tyrosine kinases
    Patent 7,169,791
    Issued: January 30, 2007
    Inventor(s): Breitenstein; Werner & Furet; Pascal & Jacob; Sandra & Manley; Paul William
    Assignee(s): Novartis AG
    The invention relates to compounds of formula wherein the substituents R1, R2 and R4 have the meaning as set forth and explained in the description of the invention, to processes for the preparation of these compounds, pharmaceutical compositions containing same, the use thereof optionally in combination with one or more other pharmaceutically active compounds for the therapy of a disease which responds to an inhibition of protein kinase activity, especially a neoplastic disease, in particular leukaemia, and a method for the treatment of such a disease.
    Patent expiration dates:
    • July 4, 2023
      ✓ 
      Patent use: A METHOD FOR THE TREATMENT OF LEUKEMIAS
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
    Patent 8,163,904
    Issued: April 24, 2012
    Inventor(s): Manley; Paul W & Shieh; Wen-Chung & Sutton; Paul Allen & Karpinski; Piotr H & Wu; Raeann & Monnier; Stéphanie & Brozio; Jörg
    Assignee(s): Novartis AG Novartis Pharma GmbH
    Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide are prepared by various processes.
    Patent expiration dates:
    • August 23, 2028
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
    Patent 8,293,756
    Issued: October 23, 2012
    Inventor(s): Bruneau; Nathalie
    Assignee(s): Novartis AG
    A pharmaceutical composition, especially capsules, comprising granules containing nilotinib or a salt thereof with at least one pharmaceutically acceptable excipient. The granules may be produced by a wet granulation process.
    Patent expiration dates:
    • September 25, 2027
      ✓ 
      Drug product
  • Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
    Patent 8,389,537
    Issued: March 5, 2013
    Assignee(s): Novartis AG
    Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide are prepared by various processes.
    Patent expiration dates:
    • July 18, 2026
      ✓ 
      Patent use: TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
    Patent 8,415,363
    Issued: April 9, 2013
    Assignee(s): Novartis AG
    Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide free base and salts thereof are prepared by various processes.
    Patent expiration dates:
    • July 18, 2026
      ✓ 
      Patent use: TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH + CML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Pharmaceutical compositions comprising nilotinib or its salt
    Patent 8,501,760
    Issued: August 6, 2013
    Assignee(s): Novartis AG
    A pharmaceutical composition, especially capsules, comprising granules containing nilotinib or a salt thereof with at least one pharmaceutically acceptable excipient. The granules may be produced by a wet granulation process.
    Patent expiration dates:
    • July 18, 2026
      ✓ 
      Drug substance
      ✓ 
      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:
    • June 17, 2014 - TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH & CML) IN CHRONIC PHASE.
    • October 29, 2014 -

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.
Hide
(web5)