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Last Updated: January 28, 2022

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ADEMPAS Drug Patent Profile


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Which patents cover Adempas, and what generic alternatives are available?

Adempas is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy patent family members in forty-three countries.

The generic ingredient in ADEMPAS is riociguat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riociguat profile page.

DrugPatentWatch® Generic Entry Outlook for Adempas

Adempas was eligible for patent challenges on October 8, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 18, 2034. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ADEMPAS
Drug Prices for ADEMPAS

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for ADEMPAS
Generic Entry Date for ADEMPAS*:
Constraining patent/regulatory exclusivity:
NDA:
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 ADEMPAS

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

SponsorPhase
ActelionPhase 3
Dr Sudarshan RajagopalPhase 3
ActelionPhase 1

See all ADEMPAS clinical trials

Pharmacology for ADEMPAS
Paragraph IV (Patent) Challenges for ADEMPAS
Tradename Dosage Ingredient NDA Submissiondate
ADEMPAS TABLET;ORAL riociguat 204819 2017-10-10

US Patents and Regulatory Information for ADEMPAS

ADEMPAS is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADEMPAS is ⤷  Sign up for a Free Trial.

This potential generic entry date is based on patent ⤷  Sign up for a Free Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ADEMPAS

Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS

Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING

Carbamate-substituted pyrazolopyridines
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ADEMPAS

International Patents for ADEMPAS

Country Patent Number Estimated Expiration
Taiwan I282792 ⤷  Sign up for a Free Trial
Morocco 38350 ⤷  Sign up for a Free Trial
Germany 50303960 ⤷  Sign up for a Free Trial
China 1665811 ⤷  Sign up for a Free Trial
Chile 2015002304 ⤷  Sign up for a Free Trial
Japan 2002521483 ⤷  Sign up for a Free Trial
Hong Kong 1082247 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for ADEMPAS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506193 C 2014 026 Romania ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUAT4,6-DIAMINO-2-[1-(-FLUORBENZIL)-1H-PIRAZOLO[3,4-B]PIRIDIN-3-IL]-5-PIRIMIDINIL(METIL)CARBAMAT DEMETIL; NATIONAL AUTHORISATION NUMBER: EU/1/13/907; DATE OF NATIONAL AUTHORISATION: 20140327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/907; DATE OF FIRST AUTHORISATION IN EEA: 20140327
1506193 92419 Luxembourg ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
1506193 C300659 Netherlands ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193 36/2014 Austria ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
1506193 CR 2014 00028 Denmark ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
1506193 PA2014018,C1506193 Lithuania ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193 132014902270282 Italy ⤷  Sign up for a Free Trial PRODUCT NAME: RIOCIGUAT(ADEMPAS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/907, 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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