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.
Summary for RIOCIGUAT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 108 |
| Clinical Trials: | 48 |
| Patent Applications: | 625 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RIOCIGUAT |
| DailyMed Link: | RIOCIGUAT at DailyMed |
Recent Clinical Trials for RIOCIGUAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Glasgow | Phase 4 |
| University of Sheffield | Phase 4 |
| University of Cambridge | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for RIOCIGUAT
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msn | RIOCIGUAT | riociguat | TABLET;ORAL | 211135-004 | Sep 1, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msn | RIOCIGUAT | riociguat | TABLET;ORAL | 211135-002 | Sep 1, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 |
