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Last Updated: May 24, 2024

Pegcetacoplan - Generic Drug Details


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What are the generic sources for pegcetacoplan and what is the scope of patent protection?

Pegcetacoplan is the generic ingredient in two branded drugs marketed by Apellis Pharms and is included in two NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pegcetacoplan has one hundred and ninety patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for pegcetacoplan
International Patents:190
US Patents:13
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 19
What excipients (inactive ingredients) are in pegcetacoplan?pegcetacoplan excipients list
DailyMed Link:pegcetacoplan at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pegcetacoplan
Generic Entry Dates for pegcetacoplan*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for pegcetacoplan*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for pegcetacoplan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 2
Roswell Park Cancer InstitutePhase 2
Swedish Orphan BiovitrumPhase 2

See all pegcetacoplan clinical trials

Pharmacology for pegcetacoplan
Drug ClassComplement Inhibitor
Mechanism of ActionComplement Inhibitors

US Patents and Regulatory Information for pegcetacoplan

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 ⤷  Sign Up
Apellis Pharms SYFOVRE pegcetacoplan SOLUTION;INTRAVITREAL 217171-001 Feb 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apellis Pharms EMPAVELI pegcetacoplan SOLUTION;SUBCUTANEOUS 215014-001 May 14, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Apellis Pharms EMPAVELI pegcetacoplan SOLUTION;SUBCUTANEOUS 215014-001 May 14, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up 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 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 pegcetacoplan

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 pegcetacoplan

Country Patent Number Title Estimated Expiration
Hong Kong 1156860 改善活性的 類似物 (COMPSTATIN ANALOGS WITH IMPROVED ACTIVITY COMPSTATIN) ⤷  Sign Up
Australia 2020260435 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods ⤷  Sign Up
Australia 2016334247 Dosing regimens ⤷  Sign Up
Russian Federation 2018116446 СХЕМЫ ВВЕДЕНИЯ ⤷  Sign Up
France 22C1025 ⤷  Sign Up
China 108431019 给药方案 (DOSING REGIMENS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pegcetacoplan

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 301178 Netherlands ⤷  Sign Up PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214
3660033 22C1025 France ⤷  Sign Up PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214
3660033 CA 2022 00023 Denmark ⤷  Sign Up PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
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.