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Riociguat - Generic Drug Details
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What are the generic drug sources for riociguat and what is the scope of patent protection?
Riociguat
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Riociguat has seventy patent family members in forty-three countries.
There are two drug master file entries for riociguat. One supplier is listed for this compound.
Summary for riociguat
International Patents: | 70 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 85 |
Clinical Trials: | 37 |
Patent Applications: | 580 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for riociguat |
What excipients (inactive ingredients) are in riociguat? | riociguat excipients list |
DailyMed Link: | riociguat at DailyMed |
Recent Clinical Trials for riociguat
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayer Yakuhin, Ltd. | Phase 2 |
National Hospital Organization Okayama Medical Center | Phase 2 |
Actelion | Phase 3 |
Pharmacology for riociguat
Drug Class | Soluble Guanylate Cyclase Stimulator |
Mechanism of Action | Guanylate Cyclase Stimulators |
US Patents and Regulatory Information for riociguat
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 | 204819-004 | Oct 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-004 | Oct 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-005 | Oct 8, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-003 | Oct 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-003 | Oct 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-002 | Oct 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-001 | Oct 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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 riociguat
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-001 | Oct 8, 2013 | Start Trial | Start Trial |
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-002 | Oct 8, 2013 | Start Trial | Start Trial |
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-003 | Oct 8, 2013 | Start Trial | Start Trial |
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-005 | Oct 8, 2013 | Start Trial | Start Trial |
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-004 | Oct 8, 2013 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for riociguat
Country | Patent Number | Estimated Expiration |
---|---|---|
Nicaragua | 201500110 | Start Trial |
European Patent Office | 3760629 | Start Trial |
Croatia | P20041166 | Start Trial |
Israel | 240397 | Start Trial |
Guatemala | 200300101 | Start Trial |
Portugal | 1506193 | Start Trial |
Mexico | 2015010725 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for riociguat
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506193 | 36/2014 | Austria | Start Trial | PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331 |
1506193 | 515 | Finland | Start Trial | |
1506193 | 132014902270282 | Italy | Start Trial | PRODUCT NAME: RIOCIGUAT(ADEMPAS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/907, 20140327 |
1506193 | 165 5014-2014 | Slovakia | Start Trial | PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140327 |
1506193 | 2014/028 | Ireland | Start Trial | PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327 |
1506193 | C 2014 026 | Romania | Start 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 | S1400019 | Hungary | Start Trial | PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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