Details for New Drug Application (NDA): 214377
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NDA 214377 describes VERQUVO, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the VERQUVO profile page.
The generic ingredient in VERQUVO is vericiguat. One supplier is listed for this compound. Additional details are available on the vericiguat profile page.
The generic ingredient in VERQUVO is vericiguat. One supplier is listed for this compound. Additional details are available on the vericiguat profile page.
Summary for 214377
| Tradename: | VERQUVO |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | vericiguat |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214377
Generic Entry Date for 214377*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 214377
| Mechanism of Action | Guanylate Cyclase Stimulators |
Suppliers and Packaging for NDA: 214377
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VERQUVO | vericiguat | TABLET;ORAL | 214377 | NDA | Merck Sharp & Dohme LLC | 0006-5028 | 0006-5028-01 | 14 TABLET, FILM COATED in 1 BOTTLE (0006-5028-01) |
| VERQUVO | vericiguat | TABLET;ORAL | 214377 | NDA | Merck Sharp & Dohme LLC | 0006-5028 | 0006-5028-02 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5028-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 19, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 19, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,736,896 | Patent Expiration: | May 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,439,642 | Patent Expiration: | May 19, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HEART FAILURE (HF) HOSPITALIZATION FOLLOWING A HOSPITALIZATION FOR HF OR NEED FOR OUTPATIENT IV DIURETICS, IN ADULTS WITH SYMPTOMATIC CHRONIC HF AND EJECTION FRACTION LESS THAN 45% | ||||||||
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