Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Colorcon
Express Scripts
Dow
Boehringer Ingelheim

Last Updated: February 3, 2023

Risdiplam - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

SponsorPhase
Clinic for Special ChildrenPhase 4
Biohaven Pharmaceuticals, Inc.Phase 3
Scholar Rock, Inc.Phase 3

See all risdiplam clinical trials

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Merck
McKesson
Medtronic
Dow
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.