VERICIGUAT - Generic Drug Details

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What are the generic drug sources for vericiguat and what is the scope of patent protection?

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:	20
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

Generic Entry Date for VERICIGUAT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4
University of Colorado, Denver	Phase 4
Memorial Sloan Kettering Cancer Center	Phase 2

See all VERICIGUAT clinical trials

Pharmacology for VERICIGUAT

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

Anatomical Therapeutic Chemical (ATC) Classes for VERICIGUAT

C01DX	Other vasodilators used in cardiac diseases
C01D	VASODILATORS USED IN CARDIAC DISEASES
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for VERICIGUAT

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Glossary

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

EU/EMA Drug Approvals for VERICIGUAT

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for VERICIGUAT

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Country	Patent Number	Title	Estimated Expiration
Malaysia	197904	METHOD FOR PRODUCING SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES	⤷ Sign Up
South Korea	102026059		⤷ Sign Up
Guatemala	201200313	5-FLUORO-1H-PIRAZOLOPIRIDINAS SUSTITUIDAS Y SU USO	⤷ Sign Up
Hong Kong	1182112	取代的 -氟- -吡唑並吡啶類化合物及其用途 (SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES AND USE THEREOF 5--1H-)	⤷ Sign Up
Japan	5883852		⤷ Sign Up
Singapore	185460	SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES AND USE THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VERICIGUAT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2576547	30/2021	Austria	⤷ Sign Up	PRODUCT NAME: VERICIGUAT SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1561 (MITTEILUNG) 20210720
2576547	CR 2021 00032	Denmark	⤷ Sign Up	PRODUCT NAME: VERICIGUAT OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE; REG. NO/DATE: EU/1/21/1561 20210720
2576547	LUC00221	Luxembourg	⤷ Sign Up	PRODUCT NAME: VERICIGUAT ET SES SELS, SOLVATES ET SOLVATES DES SELS; AUTHORISATION NUMBER AND DATE: EU/1/21/1561 20210720
2576547	2190031-1	Sweden	⤷ Sign Up	PRODUCT NAME: VERICIGUAT AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALTS; REG. NO/DATE: EU/1/21/1561 20210720
2576547	PA2021518,C2576547	Lithuania	⤷ Sign Up	PRODUCT NAME: VERICIGUATAS IR JO DRUSKOS, SOLVATAI IR DRUSKU SOLVATAI ; REGISTRATION NO/DATE: EU/1/21/1561 20210716
2576547	C02576547/01	Switzerland	⤷ Sign Up	PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68001 22.09.2021
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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