Details for New Drug Application (NDA): 219083
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NDA 219083 describes MYQORZO, which is a drug marketed by Cytokinetics 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 MYQORZO profile page.
The generic ingredient in MYQORZO is aficamten. One supplier is listed for this compound. Additional details are available on the aficamten profile page.
The generic ingredient in MYQORZO is aficamten. One supplier is listed for this compound. Additional details are available on the aficamten profile page.
Summary for 219083
| Tradename: | MYQORZO |
| Applicant: | Cytokinetics |
| Ingredient: | aficamten |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219083
Generic Entry Date for 219083*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;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.
Suppliers and Packaging for NDA: 219083
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYQORZO | aficamten | TABLET;ORAL | 219083 | NDA | Cytokinetics Inc. | 82112-105 | 82112-105-30 | 30 TABLET, FILM COATED in 1 BOTTLE (82112-105-30) |
| MYQORZO | aficamten | TABLET;ORAL | 219083 | NDA | Cytokinetics Inc. | 82112-110 | 82112-110-30 | 30 TABLET, FILM COATED in 1 BOTTLE (82112-110-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Dec 19, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,836,755 | Patent Expiration: | Jan 18, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULTS WITH SYMPTOMATIC OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (OHCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS | ||||||||
| Patent: | 12,370,179 | Patent Expiration: | Jul 15, 2042 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULTS WITH SYMPTOMATIC OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (OHCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS | ||||||||
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