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 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
International Patents: | 69 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 49 |
Patent Applications: | 1,005 |
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
Sponsor | Phase |
---|---|
University of Newcastle Upon-Tyne | Phase 4 |
Sheffield Teaching Hospitals NHS Foundation Trust | Phase 4 |
University of Glasgow | Phase 4 |
Generic filers with tentative approvals for RIOCIGUAT
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 2MG | TABLET;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
Drug Class | Soluble Guanylate Cyclase Stimulator |
Mechanism of Action | Guanylate Cyclase Stimulators |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Msn | RIOCIGUAT | riociguat | TABLET;ORAL | 211135-004 | 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 |
Bayer Hlthcare | ADEMPAS | riociguat | TABLET;ORAL | 204819-002 | 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 | |
Singapore | 11201506211R | FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE | ⤷ 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 |
1506193 | 2014/028 | Ireland | ⤷ Sign Up | PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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