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Last Updated: November 2, 2024

Riociguat - Generic Drug Details


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What are the generic sources for riociguat and what is the scope of freedom to operate?

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 sixty-nine 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
University of Newcastle Upon-TynePhase 4
Sheffield Teaching Hospitals NHS Foundation TrustPhase 4
University of GlasgowPhase 4

See all riociguat clinical trials

Generic filers with tentative approvals for RIOCIGUAT
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up2.5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up2MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up1.5MGTABLET;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 204819-004 Oct 8, 2013 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bayer Hlthcare ADEMPAS riociguat TABLET;ORAL 204819-005 Oct 8, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-001 Sep 1, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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 riociguat

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 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 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 riociguat

Country Patent Number Title Estimated Expiration
Japan 4455321 ⤷  Sign Up
Hong Kong 1217488 -二氨基- -氟苄基 -吡唑并 吡啶- -基 嘧啶- -基}甲基氨基甲酸甲酯的形式 (FORMS OF METHYL 4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4- B]PYRIDINO-3-YL]PYRIMIDINO-5-YLMETHYL CARBAMATE 4,6--2-[1-(2-)-1H-[3,4-B]-3-]-5-) ⤷  Sign Up
Japan 6386478 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for riociguat

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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