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Last Updated: April 22, 2024

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EVRYSDI Drug Patent Profile


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When do Evrysdi patents expire, and what generic alternatives are available?

Evrysdi is a drug marketed by Genentech Inc and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and fourteen patent family members in thirty-nine countries.

The generic ingredient in EVRYSDI is risdiplam. One supplier is listed for this compound. Additional details are available on the risdiplam profile page.

DrugPatentWatch® Generic Entry Outlook for Evrysdi

Evrysdi will be eligible for patent challenges on August 7, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 11, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for EVRYSDI
International Patents:114
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 3
Patent Applications: 36
Drug Prices: Drug price information for EVRYSDI
What excipients (inactive ingredients) are in EVRYSDI?EVRYSDI excipients list
DailyMed Link:EVRYSDI at DailyMed
Drug patent expirations by year for EVRYSDI
Drug Prices for EVRYSDI

See drug prices for EVRYSDI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EVRYSDI
Generic Entry Date for EVRYSDI*:
Constraining patent/regulatory exclusivity:
NDA:
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 EVRYSDI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hoffmann-La RochePhase 4
Genentech, Inc.Phase 4
Hoffmann-La RochePhase 1

See all EVRYSDI clinical trials

US Patents and Regulatory Information for EVRYSDI

EVRYSDI is protected by four US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EVRYSDI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EVRYSDI


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

Compounds for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds for treating spinal muscular atrophy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY

FDA Regulatory Exclusivity protecting EVRYSDI

TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PATIENTS 2 MONTHS OF AGE AND OLDER
Exclusivity Expiration: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PEDIATRIC PATIENTS BETWEEN BIRTH AND 2 MONTHS OF AGE
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 EVRYSDI

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 EVRYSDI

When does loss-of-exclusivity occur for EVRYSDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0442
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 15261046
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016026205
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 48561
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 16002836
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6459092
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 160518
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0192159
Estimated Expiration: ⤷  Try a Trial

Patent: 0230637
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 43025
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5068
Estimated Expiration: ⤷  Try a Trial

Patent: 1692280
Estimated Expiration: ⤷  Try a Trial

Patent: 2090486
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 43025
Estimated Expiration: ⤷  Try a Trial

Patent: 63296
Estimated Expiration: ⤷  Try a Trial

Patent: 41772
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1039
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 46491
Estimated Expiration: ⤷  Try a Trial

Patent: 100037
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8653
Estimated Expiration: ⤷  Try a Trial

Patent: 0027
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 36173
Estimated Expiration: ⤷  Try a Trial

Patent: 17515863
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 2021010
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4284
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1050
Estimated Expiration: ⤷  Try a Trial

Patent: 16014547
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 995
Estimated Expiration: ⤷  Try a Trial

Patent: 988
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1128
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5008
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 21035
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 170128
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 016502081
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 43025
Estimated Expiration: ⤷  Try a Trial

Patent: 63296
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 43025
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 718
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201609497T
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 43025
Estimated Expiration: ⤷  Try a Trial

Patent: 63296
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1607026
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2213740
Estimated Expiration: ⤷  Try a Trial

Patent: 2256013
Estimated Expiration: ⤷  Try a Trial

Patent: 170003687
Estimated Expiration: ⤷  Try a Trial

Patent: 210014219
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 61423
Estimated Expiration: ⤷  Try a Trial

Patent: 49660
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 67239
Estimated Expiration: ⤷  Try a Trial

Patent: 1609738
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 9670
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EVRYSDI around the world.

Country Patent Number Title Estimated Expiration
Ukraine 119670 СПОЛУКИ ДЛЯ ЛІКУВАННЯ СПІНАЛЬНОЇ М'ЯЗОВОЇ АТРОФІЇ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY) ⤷  Try a Trial
Philippines 12018501711 COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY ⤷  Try a Trial
Ukraine 116981 СПОЛУКИ ДЛЯ ЛІКУВАННЯ СПІНАЛЬНОЇ М'ЯЗОВОЇ АТРОФІЇ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY) ⤷  Try a Trial
Ecuador SP14017269 COMPUESTOS PARA TRATAR LA ATROFIA MUSCULAR ESPINAL ⤷  Try a Trial
Hungary E046491 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EVRYSDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3143025 C202130047 Spain ⤷  Try a Trial 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 301128 Netherlands ⤷  Try a Trial PRODUCT NAME: RISDIPLAM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1531 20210329
3143025 122021000051 Germany ⤷  Try a Trial PRODUCT NAME: RISDIPLAM ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1531 20210326
3143025 2190034-5 Sweden ⤷  Try a Trial PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1531 20210329
3143025 SPC/GB21/050 United Kingdom ⤷  Try a Trial PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1531(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.