Skip to Content

Generic Odomzo Availability

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

ODOMZO (sonidegib phosphate - capsule;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    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: 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.

  • 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:
    • February 6, 2029
      ✓ 
      Patent use: TREATMENT OF BASAL CELL CARCINOMA
      ✓ 
      Drug substance

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:
    • July 24, 2020 - 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.
Hide