Details for New Drug Application (NDA): 214998
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NDA 214998 describes CAMZYOS, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CAMZYOS profile page.
The generic ingredient in CAMZYOS is mavacamten. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mavacamten profile page.
The generic ingredient in CAMZYOS is mavacamten. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mavacamten profile page.
Summary for 214998
| Tradename: | CAMZYOS |
| Applicant: | Bristol |
| Ingredient: | mavacamten |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214998
Generic Entry Date for 214998*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 214998
| Mechanism of Action | Cardiac Myosin Inhibitors |
Suppliers and Packaging for NDA: 214998
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CAMZYOS | mavacamten | CAPSULE;ORAL | 214998 | NDA | Myokardia, Inc. | 73625-111 | 73625-111-11 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-111-11) |
| CAMZYOS | mavacamten | CAPSULE;ORAL | 214998 | NDA | Myokardia, Inc. | 73625-112 | 73625-112-11 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-112-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Apr 28, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017 | ||||||||
| Regulatory Exclusivity Expiration: | Apr 28, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Apr 28, 2029 | ||||||||
| Regulatory Exclusivity Use: | 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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