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: | 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
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 |
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 | 214377-001 | Jan 19, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Merck Sharp Dohme | VERQUVO | vericiguat | TABLET;ORAL | 214377-001 | Jan 19, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Merck Sharp Dohme | VERQUVO | vericiguat | TABLET;ORAL | 214377-001 | Jan 19, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Merck Sharp Dohme | VERQUVO | vericiguat | TABLET;ORAL | 214377-002 | Jan 19, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Merck Sharp Dohme | VERQUVO | vericiguat | TABLET;ORAL | 214377-002 | Jan 19, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 |
|---|---|---|---|
| Guatemala | 201200313 | 5-FLUORO-1H-PIRAZOLOPIRIDINAS SUSTITUIDAS Y SU USO | ⤷ Try a Trial |
| Eurasian Patent Organization | 023631 | ЗАМЕЩЕННЫЕ 5-ФТОР-1H-ПИРАЗОЛОПИРИДИНЫ И ИХ ПРИМЕНЕНИЕ (SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES AND USE THEREOF) | ⤷ Try a Trial |
| Jordan | P20210065 | عملية لتحضير 5- فلورو-1H- بيرازولوبيريدينات مستبدلة (Process for preparing substituted 5-fluoro-1H-pyrazolopyridines) | ⤷ Try a Trial |
| Singapore | 10201604192X | METHOD FOR PRODUCING SUBSTITUTED 5-FLUORO-1H-PYRAZOLOPYRIDINES | ⤷ Try a Trial |
| Brazil | 112014012414 | processo para a preparação de 5-flúor-1h-pirazolopiridinas substituídas | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VERICIGUAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2576547 | LUC00221 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: VERICIGUAT ET SES SELS, SOLVATES ET SOLVATES DES SELS; AUTHORISATION NUMBER AND DATE: EU/1/21/1561 20210720 |
| 2576547 | C02576547/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VERICIGUAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68001 22.09.2021 |
| 2576547 | CA 2021 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VERICIGUAT OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE; REG. NO/DATE: EU/1/21/1561 20210720 |
| 2576547 | CR 2021 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VERICIGUAT OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE; REG. NO/DATE: EU/1/21/1561 20210720 |
| 2576547 | C202130044 | Spain | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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