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 two NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and sixty-eight 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 April 15, 2041. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for EVRYSDI?
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Summary for EVRYSDI
| International Patents: | 168 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 3 |
| Patent Applications: | 131 |
| Drug Prices: | Drug price information for EVRYSDI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 Dates for EVRYSDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SOLUTION;ORAL |
Generic Entry Dates for EVRYSDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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
US Patents and Regulatory Information for EVRYSDI
EVRYSDI is protected by seven US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EVRYSDI is ⤷ Start Trial.
This potential generic entry date is based on patent 12,122,789.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | 11,827,646 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | 9,586,955 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | 9,969,754 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Genentech Inc | EVRYSDI | risdiplam | TABLET;ORAL | 219285-001 | Feb 11, 2025 | RX | Yes | Yes | 11,534,444 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genentech Inc | EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535-001 | Aug 7, 2020 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Genentech Inc | EVRYSDI | risdiplam | TABLET;ORAL | 219285-001 | Feb 11, 2025 | RX | Yes | Yes | 12,122,789 | ⤷ Start Trial | Y | Y | ⤷ Start 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/005145Evrysdi 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:
Australia
Patent: 19361273
Estimated Expiration: ⤷ Start Trial
Patent: 22215189
Estimated Expiration: ⤷ Start Trial
Patent: 23254978
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2021007200
Patent: formas de derivados de pirido[1,2-a] pirimidin-4-ona, sua formulação e seu processo de fabricação
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 16458
Patent: NOUVELLES FORMES DE DERIVES DE PYRIDO[1,2-A] PYRIMIDIN-4-ONE, SA FORMULATION ET SON PROCEDE DE FABRICATION (NEW FORMS OF PYRIDO[1,2-A]PYRIMIDIN-4-ONE DERIVATIVES, ITS FORMULATION AND ITS PROCESS OF MAKING)
Estimated Expiration: ⤷ Start Trial
China
Patent: 3039188
Patent: 新型吡啶并[1,2-a]嘧啶-4-酮衍生物、其制剂及制备方法 (NEW FORMS OF PYRIDO[1,2-A]PYRIMIDIN-4-ONE DERIVATIVES, ITS FORMULATION AND ITS PROCESS OF MAKING)
Estimated Expiration: ⤷ Start Trial
Patent: 0554385
Patent: 新型吡啶并[1,2-a]嘧啶-4-酮衍生物、其制剂及制备方法 (Novel pyrido [1, 2-a] pyrimidin-4-one derivatives, formulations thereof and methods of preparation)
Estimated Expiration: ⤷ Start Trial
Patent: 0554386
Patent: 新型吡啶并[1,2-a]嘧啶-4-酮衍生物、其制剂及制备方法 (Novel pyrido [1, 2-a] pyrimidin-4-one derivatives, formulations thereof and methods of preparation)
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 67256
Patent: NOUVELLES FORMES DE DÉRIVÉS DE PYRIDO[1,2-A] PYRIMIDIN-4-ONE, SA FORMULATION ET SON PROCÉDÉ DE FABRICATION (NEW FORMS OF PYRIDO[1,2-A]PYRIMIDIN-4-ONE DERIVATIVES, ITS FORMULATION AND ITS PROCESS OF MAKING)
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 1924
Patent: צורות של תולדות פירידו[2,1-a]פירימידין-4-ון, פורמלציות שלהן ותהליך להכנתן (New forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making)
Estimated Expiration: ⤷ Start Trial
Patent: 9888
Patent: צורות של תולדות פירידו[2,1-a]פירימידין-4-ון, פורמלציות שלהן ותהליך להכנתן (New forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making)
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 65686
Estimated Expiration: ⤷ Start Trial
Patent: 22505098
Patent: ピリド［１，２－ａ］ピリミジン－４－オン誘導体の新規な形態、その製剤およびその製造プロセス
Estimated Expiration: ⤷ Start Trial
Patent: 23126944
Patent: ピリド［１，２－ａ］ピリミジン－４－オン誘導体の新規な形態、その製剤およびその製造プロセス (NEW FORMS OF PYRIDO[1,2-a]PYRIMIDIN-4-ONE DERIVATIVES, FORMULATION THEREOF AND MANUFACTURING METHOD THEREOF)
Estimated Expiration: ⤷ Start Trial
Patent: 25108525
Patent: ピリド［１，２－ａ］ピリミジン－４－オン誘導体の新規な形態、その製剤およびその製造プロセス (NEW FORMS OF PYRIDO[1,2-a]PYRIMIDIN-4-ONE DERIVATIVES, FORMULATION AND PROCESS OF MAKING THEREOF)
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 21004487
Patent: NUEVAS FORMAS DE DERIVADOS DE PIRIDO[1,2-A]PIRIMIDIN-4-ONA, SU FORMULACION Y SU PROCESO DE ELABORACION. (NEW FORMS OF PYRIDO[1,2-A]PYRIMIDIN-4-ONE DERIVATIVES, ITS FORMULATION AND ITS PROCESS OF MAKING.)
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2705600
Estimated Expiration: ⤷ Start Trial
Patent: 210079317
Patent: 피리도[1,2-a]피리미딘-4-온 유도체의 형태, 그의 제형 및 그의 제조 방법
Estimated Expiration: ⤷ Start Trial
Patent: 240135889
Patent: 피리도[1,2-a]피리미딘-4-온 유도체의 형태, 그의 제형 및 그의 제조 방법 ([12-a]-4- NEW FORMS OF PYRIDO[12-A]PYRIMIDIN-4-ONE DERIVATIVES ITS FORMULATION AND ITS PROCESS OF MAKING)
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 2035411
Patent: New forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making
Estimated Expiration: ⤷ Start Trial
Patent: 61018
Estimated Expiration: ⤷ Start 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 | 2018344402 | ⤷ Start Trial | |
| Australia | 2024266812 | ⤷ Start Trial | |
| Canada | 3078137 | ⤷ Start Trial | |
| China | 111182900 | ⤷ Start Trial | |
| China | 117919251 | ⤷ Start Trial | |
| European Patent Office | 3691647 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EVRYSDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3143025 | 301128 | Netherlands | ⤷ Start Trial | PRODUCT NAME: RISDIPLAM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1531 20210329 |
| 3143025 | PA2021010 | Lithuania | ⤷ Start Trial | PRODUCT NAME: RISDIPLAMAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1531 20210326 |
| 3143025 | 2021C/537 | Belgium | ⤷ Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER |
| 3143025 | CA 2021 00037 | Denmark | ⤷ Start Trial | PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329 |
| 3143025 | 122021000051 | Germany | ⤷ Start Trial | PRODUCT NAME: RISDIPLAM ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1531 20210326 |
| 3143025 | C03143025/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: RISDIPLAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67251 06.05.2021 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for EVRYSDI
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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