Vericiguat - Generic Drug Details

What are the generic drug sources for vericiguat and what is the scope of freedom to operate?

Vericiguat is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vericiguat has two hundred and ten patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for vericiguat

International Patents:	210
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	19
Patent Applications:	282
What excipients (inactive ingredients) are in vericiguat?	vericiguat excipients list
DailyMed Link:	vericiguat at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for vericiguat

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.

Recent Clinical Trials for vericiguat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 4
Memorial Sloan Kettering Cancer Center	Phase 2
Vanderbilt University Medical Center	Phase 4

See all vericiguat clinical trials

Pharmacology for vericiguat

Drug Class	Soluble Guanylate Cyclase Stimulator
Mechanism of Action	Guanylate Cyclase Stimulators

US Patents and Regulatory Information for vericiguat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No			Y	Y
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No			Y	Y
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for vericiguat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Verquvo	vericiguat	EMEA/H/C/005319 Treatment of symptomatic chronic heart failure	Authorised	no	no	no	2021-07-16

International Patents for vericiguat

Country	Patent Number	Title	Estimated Expiration
Cuba	24257	PROCEDIMIENTO DE PREPARACIÓN DE 5- FLUORO-1H-PIRAZOLOPIRIDINAS SUSTITUIDAS
Cyprus	1124000
Costa Rica	20120597	EL USO DE ESTIMULADORES DE LA sGC, ACTIVADORES DE LA sGC, SOLOS Y EN COMBINANCIÓN CON INHIBIDORES DE LA PDE5 PARA EL TRATAMIENTO DE ESCLEROSIS SISTÉMICA (EcS)
Taiwan	I597280
Brazil	122020001312	Processo para preparação de 5-flúor-1h-pirazolopiridinas substituídas, e compostos intermediários

Supplementary Protection Certificates for vericiguat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	30/2021	Austria		PRODUCT NAME: VERICIGUAT SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1561 (MITTEILUNG) 20210720
2576547	301146	Netherlands		PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: EU/1/21/1561 20210720
2576547	122021000048	Germany		PRODUCT NAME: VERICIGUAT SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1561 20210716
2576547	C202130044	Spain		PRODUCT NAME: VERICIGUAT Y SUS SALES, SOLVATOS Y SOLVATOS DE LAS SALES.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1561; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1561; DATE OF FIRST AUTHORISATION IN EEA: 20210716
2576547	2021C/553	Belgium		PRODUCT NAME: VERICIGUAT EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/21/1561 20210720