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 five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and thirty 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 was eligible for patent challenges on August 7, 2024.
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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Summary for EVRYSDI
| International Patents: | 130 |
| US Patents: | 5 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EVRYSDI
*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
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 4 |
| Genentech, Inc. | Phase 4 |
| Hoffmann-La Roche | Phase 1 |
Pharmacology for EVRYSDI
US Patents and Regulatory Information for EVRYSDI
EVRYSDI is protected by five US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EVRYSDI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SPINAL MUSCULAR ATROPHY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds for treating spinal muscular atrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PEDIATRIC PATIENTS BETWEEN BIRTH AND 2 MONTHS OF AGE
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
Exclusivity Expiration: ⤷ Sign Up
| 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 | 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 | Y | Y | ⤷ 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 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
Patent: DERIVADOS DE PIRIDO[1,2-A]PIRIMIDIN-4-ONA PARA TRATAR ATROFIA MUSCULAR ESPINAL
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 15261046
Patent: Compounds for treating spinal muscular atrophy
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016026205
Patent: Moduladores de entrançamento de gene smn2, seu uso e seu processo de preparação, e
composições farmacêuticas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 48561
Patent: COMPOSES POUR LE TRAITEMENT D'UNE AMYOTROPHIE SPINALE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 16002836
Patent: Compuestos derivados de pirido pirimidin con actividad moduladora del empalme genico de smn2; composicion farmaceutica y uso en el tratamiento de la atrofia muscular espinal (ame).
Estimated Expiration: ⤷ Sign Up
China
Patent: 6459092
Patent: 用于治疗脊髓性肌萎缩的化合物 (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 160518
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0192159
Estimated Expiration: ⤷ Sign Up
Patent: 0230637
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 43025
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 5068
Patent: СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Patent: 1692280
Patent: СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ
Estimated Expiration: ⤷ Sign Up
Patent: 2090486
Patent: СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 43025
Patent: COMPOSÉS DESTINÉS À TRAITER L'AMYOTROPHIE SPINALE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Patent: 63296
Patent: PROCÉDÉ POUR LA PRÉPARATION DE COMPOSÉS UTILES À TRAITER L'AMYOTROPHIE SPINALE (PROCESS FOR THE PREPARATION OF COMPOUNDS USEFUL FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Patent: 41772
Patent: PROCÉDÉ DE PRÉPARATION DE COMPOSÉS UTILES POUR LE TRAITEMENT DE L'AMYOTROPHIE SPINALE (PROCESS FOR THE PREPARATION OF COMPOUNDS USEFUL FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1039
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 46491
Estimated Expiration: ⤷ Sign Up
Patent: 100037
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8653
Patent: תרכובות לטיפול בניוון שרירים שידרתי (Compounds for treating spinal muscular atrophy)
Estimated Expiration: ⤷ Sign Up
Patent: 0027
Patent: תרכובות לטיפול בניוון שרירים שידרתי (Compounds for treating spinal muscular atrophy)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 36173
Estimated Expiration: ⤷ Sign Up
Patent: 17515863
Patent: 脊髄性筋萎縮症を処置するための化合物
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 2021010
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4284
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1050
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.)
Estimated Expiration: ⤷ Sign Up
Patent: 16014547
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 995
Patent: Composés destinés à traiter l'amyotrophie spinale
Estimated Expiration: ⤷ Sign Up
Patent: 988
Patent: PROCÉDÉ POUR LA PRÉPARATION DE COMPOSÉS UTILES À TRAITER L'AMYOTROPHIE SPINALE
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1128
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5008
Patent: Compounds for treating spinal muscular atrophy
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 21035
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 170128
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 016502081
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 43025
Estimated Expiration: ⤷ Sign Up
Patent: 63296
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 43025
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 718
Patent: JEDINJENJA ZA LEČENJE SPINALNE MIŠIĆNE ATROFIJE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201609497T
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 43025
Estimated Expiration: ⤷ Sign Up
Patent: 63296
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1607026
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2213740
Estimated Expiration: ⤷ Sign Up
Patent: 2256013
Estimated Expiration: ⤷ Sign Up
Patent: 170003687
Patent: 척수성 근위축증을 치료하기 위한 화합물 (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Patent: 210014219
Patent: 척수성 근위축증을 치료하기 위한 화합물 (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 61423
Estimated Expiration: ⤷ Sign Up
Patent: 49660
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 67239
Estimated Expiration: ⤷ Sign Up
Patent: 1609738
Patent: Compounds for treating spinal muscular atrophy
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 9670
Patent: СПОЛУКИ ДЛЯ ЛІКУВАННЯ СПІНАЛЬНОЇ М'ЯЗОВОЇ АТРОФІЇ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EVRYSDI
| 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 |
| >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.
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