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Last Updated: November 2, 2024

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

SponsorPhase
Hoffmann-La RochePhase 4
Clinic for Special ChildrenPhase 4
Biohaven Pharmaceuticals, Inc.Phase 3

See all risdiplam clinical trials

Paragraph IV (Patent) Challenges for RISDIPLAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EVRYSDI For Oral Solution risdiplam 0.75 mg/mL 213535 2 2024-08-07

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 ⤷  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 ⤷  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
Ecuador SP14017269 COMPUESTOS PARA TRATAR LA ATROFIA MUSCULAR ESPINAL ⤷  Sign Up
Argentina 106717 COMPOSICIONES PARA TRATAR ATROFIA MUSCULAR ESPINAL, KITS, MÉTODOS DE TRATAMIENTO, USOS ⤷  Sign Up
Mexico 2014009696 COMPUESTOS PARA TRATAR LA ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.) ⤷  Sign Up
Argentina 100442 DERIVADOS DE PIRIDO[1,2-A]PIRIMIDIN-4-ONA PARA TRATAR ATROFIA MUSCULAR ESPINAL ⤷  Sign Up
Japan 6092897 ⤷  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 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 2190034-5 Sweden ⤷  Sign Up PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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 132021000000149 Italy ⤷  Sign Up PRODUCT NAME: RISDIPLAM O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(EVRYSDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1531, 20210329
3143025 PA2021010 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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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.