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Last Updated: November 2, 2024

RIOCIGUAT Drug Patent Profile


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Which patents cover Riociguat, and what generic alternatives are available?

Riociguat is a drug marketed by MSN and is included in one NDA.

The generic ingredient in RIOCIGUAT 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 Riociguat

A generic version of RIOCIGUAT was approved as riociguat by MSN on September 1st, 2022.

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Drug patent expirations by year 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

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
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-001 Sep 1, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-004 Sep 1, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-002 Sep 1, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-003 Sep 1, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn RIOCIGUAT riociguat TABLET;ORAL 211135-005 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

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

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