Risdiplam - Generic Drug Details
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What are the generic sources for risdiplam and what is the scope of freedom to operate?
Risdiplam
is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Risdiplam has ninety-three patent family members in thirty-seven countries.
One supplier is listed for this compound.
Summary for risdiplam
International Patents: | 93 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 28 |
Clinical Trials: | 15 |
Patent Applications: | 71 |
What excipients (inactive ingredients) are in risdiplam? | risdiplam excipients list |
DailyMed Link: | risdiplam at DailyMed |
Recent Clinical Trials for risdiplam
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Clinic for Special Children | Phase 4 |
Biohaven Pharmaceuticals, Inc. | Phase 3 |
Scholar Rock, Inc. | Phase 3 |
US Patents and Regulatory Information 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies., |
Authorised | no | no | yes | 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 |
---|---|---|---|
Denmark | 2812004 | See Plans and Pricing | |
Mexico | 371050 | COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.) | See Plans and Pricing |
Poland | 3143025 | See Plans and Pricing | |
Philippines | 12014501786 | COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for risdiplam
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3143025 | 2021C/537 | Belgium | See Plans and Pricing | PRODUCT NAME: RISDIPLAM OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1531 20210329 |
3143025 | 301128 | Netherlands | See Plans and Pricing | PRODUCT NAME: RISDIPLAM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1531 20210329 |
3143025 | CA 2021 00037 | Denmark | See Plans and Pricing | PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329 |
3143025 | CR 2021 00037 | Denmark | See Plans and Pricing | PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |