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Last Updated: March 28, 2024

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 three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine 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® Litigation and Generic Entry Outlook for Adempas

A generic version of ADEMPAS was approved as riociguat by MSN on September 1st, 2022.

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Drug patent expirations by year for ADEMPAS
Drug Prices for ADEMPAS

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Recent Clinical Trials for ADEMPAS

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

SponsorPhase
University of Newcastle Upon-TynePhase 4
Sheffield Teaching Hospitals NHS Foundation TrustPhase 4
University of GlasgowPhase 4

See all ADEMPAS clinical trials

Pharmacology for ADEMPAS
Paragraph IV (Patent) Challenges for ADEMPAS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADEMPAS Tablets riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg 204819 3 2017-10-10

US Patents and Regulatory Information for ADEMPAS

ADEMPAS is protected by five US patents.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a 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

Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid- ino-5-yl}methyl carbamate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a 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]pyrimid- ino-5-yl}methyl carbamate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a 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: ⤷  Try a Trial
Patent Expiration: ⤷  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
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 AB RX Yes Yes ⤷  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

Expired US Patents for ADEMPAS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ADEMPAS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bayer AG Adempas riociguat EMEA/H/C/002737
Chronic thromboembolic pulmonary hypertension (CTEPH)Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III withinoperable CTEPH,persistent or recurrent CTEPH after surgical treatment,to improve exercise capacity.Pulmonary arterial hypertension (PAH)AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists. 
Authorised no no no 2014-03-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ADEMPAS

When does loss-of-exclusivity occur for ADEMPAS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14220801
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015019571
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 07859
Estimated Expiration: ⤷  Try a Trial

Patent: 01636
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 15002304
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5102457
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 150422
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 150092
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 015000199
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1500852
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58914
Estimated Expiration: ⤷  Try a Trial

Patent: 60629
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 17488
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 86478
Estimated Expiration: ⤷  Try a Trial

Patent: 16509039
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 15010725
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 350
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1500110
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 151590
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 015501839
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201506211R
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 150119871
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 15000361
Estimated Expiration: ⤷  Try a 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.

See the table below for additional patents covering ADEMPAS around the world.

Country Patent Number Title Estimated Expiration
Canada 2485143 PYRAZOLOPYRIDINES A SUBSTITUTION CARBAMATE (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES) ⤷  Try a Trial
El Salvador 1999000118 NUEVOS DERIVADOS DE PIRAZOL SUBSTITUIDOS REF. LEA 33188-SV ⤷  Try a Trial
Peru 09322000 ⤷  Try a Trial
Austria 313543 ⤷  Try a Trial
Japan 4455321 ⤷  Try a Trial
Brazil PI0309855 pirazolpiridinas substituídas com carbamato, seus usos e seu processo de preparação, e medicamentos ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADEMPAS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506193 132014902270282 Italy ⤷  Try a Trial PRODUCT NAME: RIOCIGUAT(ADEMPAS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/907, 20140327
1506193 CR 2014 00028 Denmark ⤷  Try a Trial PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
1506193 C300659 Netherlands ⤷  Try a Trial PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193 PA2014018,C1506193 Lithuania ⤷  Try a Trial PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193 92419 Luxembourg ⤷  Try a Trial PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
1506193 SPC/GB14/044 United Kingdom ⤷  Try a Trial PRODUCT NAME: RIOCIGUAT, I.E. METHYL N-(4,6-DIAMINO-2-(1-(2-FLUOROBENZYL)-1H-PYRAZOLO (3,4-B)PYRIDIN-3-YL)-5-PYRIMIDINYL(METHYL)CARBAMATE,OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE THEREOF.; REGISTERED: UK EU/1/13/907 20140331
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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