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Last Updated: March 9, 2021

DrugPatentWatch Database Preview

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

SponsorPhase
Bayer Yakuhin, Ltd.Phase 2
National Hospital Organization Okayama Medical CenterPhase 2
ActelionPhase 3

See all riociguat clinical trials

Pharmacology for riociguat
Paragraph IV (Patent) Challenges for RIOCIGUAT
Tradename Dosage Ingredient NDA Submissiondate
ADEMPAS TABLET;ORAL riociguat 204819 2017-10-10

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

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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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Medtronic
Mallinckrodt
Boehringer Ingelheim
Express Scripts

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.