Generic Camzyos Availability
Last updated on Jan 8, 2025.
Camzyos is a brand name of mavacamten, approved by the FDA in the following formulation(s):
CAMZYOS (mavacamten - capsule;oral)
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Manufacturer: BRISTOL
Approval date: April 28, 2022
Strength(s): 2.5MG [RLD], 5MG [RLD], 10MG [RLD], 15MG [RLD]
Has a generic version of Camzyos been approved?
No. There is currently no therapeutically equivalent version of Camzyos available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Camzyos. 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.
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Pyrimidinedione compounds
Patent 9,585,883
Issued: March 7, 2017
Inventor(s): Oslob Johan & Anderson Robert & Aubele Danielle & Evanchik Marc & Fox Jonathan Charles & Kane Brian & Lu Puping & McDowell Robert & Rodriguez Hector & Song Yonghong & Sran Arvinder
Assignee(s): MYOKARDIA, INC.Provided are novel pyrimidine dione compounds and pharmaceutically acceptable salts thereof, that are useful for the treatment of hypertrophic cardiomyopathy (HCM) and conditions associated with left ventricular hypertrophy or diastolic dysfunction. The synthesis and characterization of the compounds and pharmaceutically acceptable salts thereof, are described, as well as methods for treating HCM and other forms of heart disease.
Patent expiration dates:
- June 19, 2034✓
- June 19, 2034
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Patent RE50050
Patent expiration dates:
- June 19, 2034✓✓
- June 19, 2034
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 15, 2026 - LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017
- April 28, 2027 - NEW CHEMICAL ENTITY
- April 28, 2029 - TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
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Glossary
Term | Definition |
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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.