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.
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: | 17 |
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 Cambridge | Phase 4 |
University of Newcastle Upon-Tyne | Phase 4 |
Sheffield Teaching Hospitals NHS Foundation Trust | Phase 4 |
Pharmacology for ADEMPAS
Drug Class | Soluble Guanylate Cyclase Stimulator |
Mechanism of Action | Guanylate Cyclase Stimulators |
Anatomical Therapeutic Chemical (ATC) Classes for ADEMPAS
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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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
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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
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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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Patent Expiration: ⤷ Sign Up
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 | 204819-001 | Oct 8, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-002 | 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
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015019571
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 07859
Estimated Expiration: ⤷ Sign Up
Patent: 01636
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 15002304
Estimated Expiration: ⤷ Sign Up
China
Patent: 5102457
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 150422
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 150092
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 015000199
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1500852
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 58914
Estimated Expiration: ⤷ Sign Up
Patent: 60629
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 17488
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 86478
Estimated Expiration: ⤷ Sign Up
Patent: 16509039
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 15010725
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 350
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1500110
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 151590
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 015501839
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201506211R
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 150119871
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Tunisia
Patent: 15000361
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 |
---|---|---|---|
Netherlands | 300659 | ⤷ Sign Up | |
European Patent Office | 2958914 | 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) | ⤷ Sign Up |
Nicaragua | 201500110 | FORMAS DEL METIL {4,6-DIAMINO-2-[1-(2-FLUOROBENCIL)-1h-PIRAZOLO [4,3-B] PIRIDINO-3-IL]PIRIMIDINO-5-IL} METIL CARBAMATO | ⤷ 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 | 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 |
1506193 | 300659 | Netherlands | ⤷ Sign Up | PRODUCT NAME: RIOCIGUAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/907 20140331 |
1506193 | 132014902270282 | Italy | ⤷ Sign Up | 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 |