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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Summary for ADEMPAS
| International Patents: | 69 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 108 |
| Clinical Trials: | 18 |
| Patent Applications: | 528 |
| Drug Prices: | Drug price information for ADEMPAS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADEMPAS |
| What excipients (inactive ingredients) are in ADEMPAS? | ADEMPAS excipients list |
| DailyMed Link: | ADEMPAS at DailyMed |
Recent Clinical Trials for ADEMPAS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Sheffield | Phase 4 |
| University of Cambridge | Phase 4 |
| University of Newcastle Upon-Tyne | Phase 4 |
Pharmacology for ADEMPAS
| Drug Class | Soluble Guanylate Cyclase Stimulator |
| Mechanism of Action | Guanylate Cyclase Stimulators |
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
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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
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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
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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 | 204819-005 | Oct 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-001 | Oct 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-003 | 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 |
|---|---|---|---|
| Norway | 2014018 | ⤷ Sign Up | |
| Peru | 09322000 | ⤷ Sign Up | |
| Poland | 214985 | ⤷ 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 | S1400019 | Hungary | ⤷ Sign Up | PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327 |
| 1506193 | 122014000041 | Germany | ⤷ Sign Up | PRODUCT NAME: RIOCIGUAT SOWIE SALZE, ISOMERE UND HYDRATE DAVON; REGISTRATION NO/DATE: EU/1/13/907 20140327 |
| 1506193 | 1490030-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: RIOCIGUAT OCH SALTER, ISOMERER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/13/907 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.
ISSN: 2162-2639
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