Skip to main content

Generic Odomzo Availability

Last updated on Jan 11, 2023.

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

ODOMZO (sonidegib phosphate - capsule;oral)

  • Manufacturer: SUN PHARM
    Approval date: July 24, 2015
    Strength(s): EQ 200MG BASE [RLD]

Has a generic version of Odomzo been approved?

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

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

  • Crystaline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-Methyl-4′-(trifluoromethoxy) [1,1′-biphenyl]-3-Methanamide monophosphate, and process of preparation thereof
    Patent 10,266,523
    Issued: April 23, 2019

    The present disclosure relates to novel crystalline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy) [1,1′-biphenyl]-3-carboxamide monophosphate, and process of preparation thereof. The crystalline form of the monophosphate of a compound of formula (I) has low hygroscopicity, is convenient to store, has better stability than that of diphosphonate in prior art, can avoid the risk of crystal transformation in the development and production of the drug. The preparation method is simple, has low cost, and has important value for further optimization and development of the drug.

    Patent expiration dates:

    • March 30, 2036
      Drug substance
      Drug product
  • Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide
    Patent 8,063,043
    Issued: November 22, 2011
    Inventor(s): Bajwa; Joginder & de la Cruz; Marilyn & Dodd; Stephanie Kay & Waykole; Liladhar Murlidhar & Wu; Raeann
    Assignee(s): Novartis AG

    Salts of N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide are prepared and characterized.

    Patent expiration dates:

    • September 15, 2029
      Drug substance
      Drug product
  • Compounds and compositions as hedgehog pathway modulators
    Patent 8,178,563
    Issued: May 15, 2012
    Inventor(s): Gao; Wenqi & Jiang; Jiqing & Wan; Yongqin & Cheng; Dai & Han; Dong & Wu; Xu & Pan; Shifeng
    Assignee(s): IRM LLC

    The invention provides a method for modulating the activity of the hedgehog signaling pathway. In particular, the invention provides a method for inhibiting aberrant growth states resulting from phenotypes such as Ptc loss-of-function, hedgehog gain-of-function, smoothened gain-of-function or Gli gain-of-function, comprising contacting a cell with a sufficient amount of a compound of Formula I.

    Patent expiration dates:

    • July 24, 2029
      Drug substance


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.