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 seventy-seven patent family members in twenty-five 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
Summary for SYFOVRE
International Patents: | 177 |
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
Generic Entry Date for SYFOVRE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVITREAL |
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for SYFOVRE
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 ⤷ 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 SYFOVRE
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN EVERY OTHER MONTH
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF 15 MG PEGCETACOPLAN MONTHLY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compstatin analogs with improved activity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of treating age-related macular degeneration by compstatin and analogs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Potent compstatin analogs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apellis Pharms | SYFOVRE | pegcetacoplan | SOLUTION;INTRAVITREAL | 217171-001 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | 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 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
Estimated Expiration: ⤷ Try a Trial
Patent: 18247243
Estimated Expiration: ⤷ Try a Trial
Patent: 20260435
Estimated Expiration: ⤷ Try a Trial
Patent: 23200929
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015011244
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 91673
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5051057
Estimated Expiration: ⤷ Try a Trial
Patent: 0882376
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0211342
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 24474
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 20201
Estimated Expiration: ⤷ Try a Trial
Patent: 60033
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 20201
Estimated Expiration: ⤷ Try a Trial
Patent: 60033
Estimated Expiration: ⤷ Try a Trial
Patent: 29206
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1025
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 15445
Estimated Expiration: ⤷ Try a Trial
Patent: 17336
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 55564
Estimated Expiration: ⤷ Try a Trial
Patent: 200026
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6004
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 73167
Estimated Expiration: ⤷ Try a Trial
Patent: 93871
Estimated Expiration: ⤷ Try a Trial
Patent: 41271
Estimated Expiration: ⤷ Try a Trial
Patent: 16505527
Estimated Expiration: ⤷ Try a Trial
Patent: 19070011
Estimated Expiration: ⤷ Try a Trial
Patent: 21107441
Estimated Expiration: ⤷ Try a Trial
Patent: 22120193
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 2022010
Estimated Expiration: ⤷ Try a Trial
Patent: 60033
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6404
Estimated Expiration: ⤷ Try a Trial
Patent: 15006154
Estimated Expiration: ⤷ Try a Trial
Patent: 19007709
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 22017
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 20201
Estimated Expiration: ⤷ Try a Trial
Patent: 60033
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 20201
Estimated Expiration: ⤷ Try a Trial
Patent: 60033
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 05215
Estimated Expiration: ⤷ Try a Trial
Patent: 15119165
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 243
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 60033
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 80674
Estimated Expiration: ⤷ Try a Trial
Patent: 79430
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 SYFOVRE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2474586 | ЭФФЕКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА (EFFICIENT COMPSTATIN ANALOGUES) | ⤷ Try a Trial |
Denmark | 1549333 | ⤷ Try a Trial | |
Australia | 2016253654 | Injectable combination therapy for eye disorders | ⤷ Try a Trial |
Portugal | 2920201 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYFOVRE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3660033 | 2022C/522 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
3660033 | CA 2022 00023 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214 |
3660033 | LUC00265 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
3660033 | 301178 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |