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Last Updated: March 29, 2024

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.
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 ActionGuanylate 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:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jan 19, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 19, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try a TrialPatent Expiration:May 19, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:May 19, 2031Product 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.