Risdiplam - Generic Drug Details
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What are the generic drug sources for risdiplam and what is the scope of patent protection?
Risdiplam
is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Risdiplam has one hundred and thirty patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for risdiplam
International Patents: | 130 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 18 |
Patent Applications: | 69 |
What excipients (inactive ingredients) are in risdiplam? | risdiplam excipients list |
DailyMed Link: | risdiplam at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for risdiplam
Generic Entry Date for risdiplam*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SOLUTION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for risdiplam
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hoffmann-La Roche | Phase 4 |
Clinic for Special Children | Phase 4 |
Biohaven Pharmaceuticals, Inc. | Phase 3 |
Pharmacology for risdiplam
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ 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 risdiplam
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Roche Registration GmbH | Evrysdi | risdiplam | EMEA/H/C/005145 Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. |
Authorised | no | no | no | 2021-03-26 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for risdiplam
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 3002494 | COMPOSITIONS POUR LE TRAITEMENT D'UNE AMYOTROPHIE SPINALE (COMPOSITIONS FOR TREATING SPINAL MUSCULAR ATROPHY) | ⤷ Sign Up |
Eurasian Patent Organization | 036399 | КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ (COMPOSITIONS FOR TREATING SPINAL MUSCULAR ATROPHY) | ⤷ Sign Up |
South Africa | 201607026 | COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY | ⤷ Sign Up |
Australia | 2017204248 | COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY | ⤷ Sign Up |
Taiwan | 201336842 | Compounds for treating spinal muscular atrophy | ⤷ Sign Up |
Mexico | 2023004924 | NUEVO TRATAMIENTO DE LA ATROFIA MUSCULAR ESPINAL (SMA). (NEW TREATMENT OF SMA.) | ⤷ Sign Up |
Eurasian Patent Organization | 037123 | СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for risdiplam
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3143025 | 2190034-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1531 20210329 |
3143025 | CA 2021 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329 |
3143025 | SPC/GB21/050 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1531(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329 |
3143025 | C202130047 | Spain | ⤷ Sign Up | PRODUCT NAME: RISDIPLAM O SUS SALES FARMACEUTICAMENTE ACEPTABLES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1531; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1531; DATE OF FIRST AUTHORISATION IN EEA: 20210326 |
3143025 | C03143025/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RISDIPLAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67251 06.05.2021 |
3143025 | PA2021010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RISDIPLAMAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1531 20210326 |
3143025 | PA2021010,C3143025 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RISDIPLAMAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1531 20210326 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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