SYFOVRE Drug Patent Profile
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When do Syfovre patents expire, and when can generic versions of Syfovre launch?
Syfovre is a drug marketed by Apellis Pharms and is included in one NDA. There are eleven patents protecting this drug.
This drug has one hundred and eighty patent family members in twenty-six countries.
The generic ingredient in SYFOVRE is pegcetacoplan. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.
DrugPatentWatch® Generic Entry Outlook for Syfovre
Syfovre will be eligible for patent challenges on May 14, 2025. 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 November 15, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for SYFOVRE
| International Patents: | 180 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for SYFOVRE |
| What excipients (inactive ingredients) are in SYFOVRE? | SYFOVRE excipients list |
| DailyMed Link: | SYFOVRE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SYFOVRE
*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.
Pharmacology for SYFOVRE
| Drug Class | Complement Inhibitor |
| Mechanism of Action | Complement Inhibitors |
US Patents and Regulatory Information for SYFOVRE
SYFOVRE is protected by fourteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYFOVRE 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 SYFOVRE
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN EVERY OTHER MONTH
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN MONTHLY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN MONTHLY OR EVERY OTHER MONTH
Potent compstatin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compstatin analogs with improved activity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating age-related macular degeneration by compstatin and analogs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Methods of treating age-related macular degeneration by compstatin and analogs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN AND ALSO ADMINISTERING AN ANTI-VEGF AGENT
Method of treating age-related macular degeneration comprising administering a compstatin analog
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Potent compstatin analogs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERING COMPLEMENT INHIBITOR PEGCETACOPLAN
FDA Regulatory Exclusivity protecting SYFOVRE
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
NEW CHEMICAL ENTITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 SYFOVRE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Swedish Orphan Biovitrum AB (publ) | Aspaveli | pegcetacoplan | EMEA/H/C/005553 Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months. |
Authorised | no | no | yes | 2021-12-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SYFOVRE
When does loss-of-exclusivity occur for SYFOVRE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13344462
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷ Sign Up
Patent: 18247243
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷ Sign Up
Patent: 20260435
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷ Sign Up
Patent: 23200929
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015011244
Patent: ANÁLOGOS DE COMPSTATINA DE AÇÃO PROLONGADA, MÉTODO DE FABRICAÇÃO E USO DOS MESMOS, BEM COMO COMPOSIÇÃO DE QUALIDADE FARMACÊUTICA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 91673
Patent: ANALOGUES DE LA COMPSTATINE REACTIFS AUX CELLULES, A LONGUE DUREE D'ACTION OU CIBLES ET COMPOSITIONS ET METHODES ASSOCIEES (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 5051057
Patent: Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Estimated Expiration: ⤷ Sign Up
Patent: 0882376
Patent: 细胞反应性的、长效的或靶向的坎普他汀类似物及相关组合物和方法 (Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0211342
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 24474
Estimated Expiration: ⤷ Sign Up
Patent: 22015
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 20201
Estimated Expiration: ⤷ Sign Up
Patent: 60033
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 20201
Patent: ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Patent: 60033
Patent: ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Patent: 29206
Patent: ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1025
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 15445
Patent: 細胞反應性的、長效的或靶向的坎普他汀類似物及相關組合物和方法 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Patent: 17336
Patent: 細胞反應性的、長效的或靶向的坎普他汀類似物及相關組合物和方法 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 55564
Estimated Expiration: ⤷ Sign Up
Patent: 200026
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6004
Patent: אנלוגים של קומפסטאטין המגיבים בתא, פועלים בטווח ארוך או מיועדים למטרה ותכשירים קשורים ושיטות (Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 73167
Estimated Expiration: ⤷ Sign Up
Patent: 93871
Estimated Expiration: ⤷ Sign Up
Patent: 41271
Estimated Expiration: ⤷ Sign Up
Patent: 16505527
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法
Estimated Expiration: ⤷ Sign Up
Patent: 19070011
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法 (CELL-REACTIVE-, LONG-ACTING- OR TARGETED COMPSTATIN ANALOGS, RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Patent: 21107441
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法 (CELL-REACTIVE, LONG-ACTING OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Patent: 22120193
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法
Estimated Expiration: ⤷ Sign Up
Patent: 24056923
Patent: 細胞反応性、長時間作用型または標的化コンプスタチン類似体ならびに関係する組成物および方法 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 2022010
Estimated Expiration: ⤷ Sign Up
Patent: 60033
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 6404
Patent: ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCIÓN PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷ Sign Up
Patent: 15006154
Patent: ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCIÓN PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷ Sign Up
Patent: 19007709
Patent: ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCION PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1178
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 22017
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 20201
Estimated Expiration: ⤷ Sign Up
Patent: 60033
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 20201
Estimated Expiration: ⤷ Sign Up
Patent: 60033
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 05215
Patent: КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ И СВЯЗАННЫЕ С НИМИ КОМПОЗИЦИИ И СПОСОБЫ (CELL-REACTIVE COMPOSTATIN ANALOGUES, LONG-ACTING COMPSTATIN ANALOGUES OR COMPUTED EFFECT ANALOGUES OF TARGETED ACTION AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Patent: 15119165
Patent: КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ, И СВЯЗАННЫЕ С НИМИ КОМПОЗИЦИИ И СПОСОБЫ
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 243
Patent: ANALOZI KOMPSTATINA SA PRODUŽENIM TRAJANJEM DEJSTVA I NJIHOVE KOMPOZICIJE I POSTUPCI (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 60033
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 80674
Estimated Expiration: ⤷ Sign Up
Patent: 79430
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 SYFOVRE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2311480 | Analogues de la compstatine dotés d'une activité améliorée (Compstatin analogs with improved activity) | ⤷ Sign Up |
| European Patent Office | 3660033 | ANALOGUES DE LA COMPSTATINE À LONGUE DURÉE D'ACTION ET COMPOSITIONS ET MÉTHODES ASSOCIÉES (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014078731 | ⤷ Sign Up | |
| Japan | 2017155056 | 細胞反応性、長時間作用型または標的化コンプスタチン類似体およびその使用 (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOG AND USE THEREOF) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYFOVRE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3660033 | LUC00265 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
| 3660033 | 2022C/522 | Belgium | ⤷ Sign Up | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
| 3660033 | C202230025 | Spain | ⤷ Sign Up | PRODUCT NAME: PEGCETACOPLAN; NATIONAL AUTHORISATION NUMBER: EU/1/21/1595; DATE OF AUTHORISATION: 20211213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1595; DATE OF FIRST AUTHORISATION IN EEA: 20211213 |
| 3660033 | 122022000034 | Germany | ⤷ Sign Up | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211213 |
| >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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