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
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 |
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
Sponsor | Phase |
---|---|
Hoffmann-La Roche | Phase 4 |
Genentech, Inc. | Phase 4 |
Hoffmann-La Roche | Phase 1 |
Pharmacology for EVRYSDI
Anatomical Therapeutic Chemical (ATC) Classes for EVRYSDI
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 | ||
>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 |
---|---|---|---|
Australia | 2013216870 | Compounds for treating spinal muscular atrophy | ⤷ Try a Trial |
Spain | 2949660 | ⤷ Try a Trial | |
Japan | 6363744 | ⤷ 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |