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Last Updated: June 24, 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
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Recent Clinical Trials for ADEMPAS

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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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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
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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
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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 204819-003 Oct 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 ⤷  Sign Up ⤷  Sign Up
>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
Patent: Forms of methyl {4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridino-3-yl]pyrimidino-5-yl}methyl carbamate
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015019571
Patent: formas de {4,6-diamino-2-[1-(2-fluorobenzil)-1h-pirazolo[3,4-b]piridino-3-il]pirimidino-5-il}metilcarbamato de metila
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 07859
Patent: FORMES DE METHYLE {4,6-DIAMINO-2-[1-(2-FLUOROBENZYLE)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRI MIDINO-5-YL}METHYLE CARBAMATE (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE)
Estimated Expiration: ⤷  Sign Up

Patent: 01636
Patent: FORMES DU {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDIN-3-YL]PYRIMIDIN-5-YL}METHYLCARBAMATE DE METHYLE (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 15002304
Patent: Formas del metil {4,6-diamino-2- [1- (2-fluorobencil)-1h-pirazolo [3,4-b] piridino-3-il] pirimidino-5-il} metil carbamato
Estimated Expiration: ⤷  Sign Up

China

Patent: 5102457
Patent: Forms of methyl {4, 6-diamino-2-[1-(2-fluorobenzyl)-1h-pyrazolo[3, 4-b]pyridino-3-yl]pyrimidino-5-yl}methyl carbamate
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 150422
Patent: FORMAS DE METILO {4,6-DIAMINO-2-[1- (2-FLUOROBENCIL) -1H-PIRAZOLO [3,4-B] PIRIDINO -3-IL] PIRIMIDINO-5-IL} CARBAMATO DE METILO
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 150092
Patent: FORMAS DEL METIL {4,6-DIAMINO-2-[1-(2-FLUOROBENCIL)-1H-PIRAZOLO [3,4-B] PIRIDINO-3-IL] PIRIMIDINO-5-IL} METIL CARBAMATO
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 015000199
Patent: FORMAS DEL METIL {4,6-DIAMINO-2- [1-(2-FLUOROBENCIL)-1H-PIRAZOLO [3,4-B] PIRIDINO-3-IL] PIRIMIDINO-5-IL} METIL CARBAMATO
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1500852
Patent: ФОРМЫ МЕТИЛ {4,6-ДИАМИНО-2-[1-(2-ФТОРБЕНЗИЛ)-1Н-ПИРАЗОЛО[3,4-В]ПИРИДИНО-3-ИЛ]ПИРИМИДИНО-5-ИЛ}МЕТИЛ КАРБАМАТА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 58914
Patent: FORMES DU {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDIN-3-YL]PYRIMIDIN-5-YL}MÉTHYLCARBAMATE DE MÉTHYLE (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE)
Estimated Expiration: ⤷  Sign Up

Patent: 60629
Patent: FORMES DU {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDIN-3-YL]PYRIMIDIN-5-YL}MÉTHYLCARBAMATE DE MÉTHYLE (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 17488
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 86478
Estimated Expiration: ⤷  Sign Up

Patent: 16509039
Patent: メチル{4,6−ジアミノ−2−[1−(2−フルオロベンジル)−1H−ピラゾロ[3,4−B]ピリジノ−3−イル]ピリミジノ−5−イル}メチルカルバメートの形態
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 15010725
Patent: FORMAS DE METIL {4,6-DIAMINO-2-[1-(2-FLUOROBENCIL)-1H-PIRAZOLO [3,4-B] PIRIDINO-3-IL] PIRIMIDINO-5-IL} METIL CARBAMATO. (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3, 4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 350
Patent: Formes du {4,6-diamino-2-[1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}méthylcarbamate de méthyle
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1500110
Patent: FORMAS DEL METIL {4,6-DIAMINO-2-[1-(2-FLUOROBENCIL)-1h-PIRAZOLO [4,3-B] PIRIDINO-3-IL]PIRIMIDINO-5-IL} METIL CARBAMATO
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 151590
Patent: FORMAS DEL METIL {4,6-DIAMINO-2- [1-(2-FLUOROBENCIL)-1H-PIRAZOLO [3,4-B] PIRIDINO-3-IL] PIRIMIDINO-5-IL} METIL CARBAMATO
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 015501839
Patent: FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201506211R
Patent: FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 150119871
Patent: 메틸 {4,6-디아미노-2-[1-(2-플루오로벤질)-1H-피라졸로[3,4-b]피리디노-3-일]피리미디노-5-일}메틸 카르바메이트의 형태 (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE)
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 15000361
Patent: FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE
Estimated Expiration: ⤷  Sign Up

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
Australia 2003233061 CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES ⤷  Sign Up
European Patent Office 1102768 DERIVES DE PYRAZOLE SUBSTITUES, CONDENSES AVEC DES NOYAUX HETEROCYCLIQUES A SIX CHAINES (SUBSTITUTED PYRAZOLE DERIVATIVES CONDENSED WITH SIX-MEMBERED HETEROCYCLIC RINGS) ⤷  Sign Up
Japan 6386478 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADEMPAS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506193 122014000041 Germany ⤷  Sign Up PRODUCT NAME: RIOCIGUAT SOWIE SALZE, ISOMERE UND HYDRATE DAVON; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193 SPC/GB14/044 United Kingdom ⤷  Sign Up 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
1506193 2014/028 Ireland ⤷  Sign Up PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.