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Last Updated: December 5, 2022

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 two branded drugs marketed by Bayer Hlthcare and MSN, and is included in two NDAs. There are three 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. There is one tentative approval for this compound.

Summary for riociguat
Recent Clinical Trials for riociguat

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Heidelberg UniversityPhase 2
Dr Sudarshan RajagopalPhase 3
Merck Sharp & Dohme Corp.Phase 4

See all riociguat clinical trials

Generic filers with tentative approvals for RIOCIGUAT
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing2MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1.5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for riociguat
Paragraph IV (Patent) Challenges for RIOCIGUAT
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 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 204819-002 Oct 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-003 Oct 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-004 Sep 1, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 AB RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 204819-003 Oct 8, 2013 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-001 Oct 8, 2013 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-004 Oct 8, 2013 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-002 Oct 8, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for riociguat

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 with- inoperable CTEPH,- persistent or recurrent CTEPH after surgical treatment,to improve exercise capacity (see section 5.1).Pulmonary arterial hypertension (PAH)Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for thetreatment 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 orPAH associated with connective tissue disease (see section 5.1).  
Authorised no no no 2014-03-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for riociguat

Country Patent Number Title Estimated Expiration
Australia 2003233061 CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES See Plans and Pricing
Ukraine 78314 КАРБАМАТ-ЗАМЕЩЕННЫЕ ПИРАЗОЛОПИРИДИНЫ;КАРБАМАТЗАМІЩЕНІ ПІРАЗОЛОПІРИДИНИ (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES) See Plans and Pricing
Mexico PA04011003 PIRAZOLPIRIDINAS SUSTITUIDAS CON CARBAMATO. (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES.) See Plans and Pricing
Peru 20040197 PIRAZOLOPIRIDINAS SUSTITUIDAS CON CARBAMATO See Plans and Pricing
Eurasian Patent Organization 201500852 ФОРМЫ МЕТИЛ {4,6-ДИАМИНО-2-[1-(2-ФТОРБЕНЗИЛ)-1Н-ПИРАЗОЛО[3,4-В]ПИРИДИНО-3-ИЛ]ПИРИМИДИНО-5-ИЛ}МЕТИЛ КАРБАМАТА See Plans and Pricing
Netherlands 300659 See Plans and Pricing
Philippines 12015501839 FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for riociguat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506193 165 5014-2014 Slovakia See Plans and Pricing PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193 2014/028 Ireland See Plans and Pricing PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
1506193 CR 2014 00028 Denmark See Plans and Pricing PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
1506193 PA2014018 Lithuania See Plans and Pricing PRODUCT NAME: ; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193 S1400019 Hungary See Plans and Pricing PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327
1506193 PA2014018,C1506193 Lithuania See Plans and Pricing PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193 2014C/030 Belgium See Plans and Pricing PRODUCT NAME: RIOCIGUAT; AUTHORISATION NUMBER AND DATE: EU/1/13/907 20140331
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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