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*:
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.
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 |
Pharmacology for vericiguat
Drug Class | Soluble Guanylate Cyclase Stimulator |
Mechanism of Action | Guanylate Cyclase Stimulators |
Anatomical Therapeutic Chemical (ATC) Classes for vericiguat
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 | 214377-002 | 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 | 214377-001 | 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 | ||||
>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
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2694158 | ⤷ Sign Up | |
Lithuania | 2896617 | ⤷ Sign Up | |
Canada | 2800709 | UTILISATION DE STIMULATEURS DE LA SGC, D'ACTIVATEURS DE LA SGC, SEULS ET EN ASSOCIATION AVEC DES INHIBITEURS DE LA PDE5 EN VUE DU TRAITEMENT DE LA SCLERODERMIE SYSTEMIQUE (THE USE OF SGC STIMULATORS, SGC ACTIVATORS, ALONE AND COMBINATIONS WITH PDE5 INHIBITORS FOR THE TREATMENT OF SYSTEMIC SCLEROSIS (SSC)) | ⤷ Sign Up |
Netherlands | 301146 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vericiguat
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2576547 | C202130044 | Spain | ⤷ Sign Up | 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 | 132021000000137 | Italy | ⤷ Sign Up | PRODUCT NAME: VERICIGUAT(VERQUVO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1561, 20210720 |
2576547 | 2021C/553 | Belgium | ⤷ Sign Up | PRODUCT NAME: VERICIGUAT EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/21/1561 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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