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Last Updated: July 20, 2024

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EMPAVELI Drug Patent Profile


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When do Empaveli patents expire, and when can generic versions of Empaveli launch?

Empaveli is a drug marketed by Apellis Pharms and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and forty-four patent family members in twenty-six countries.

The generic ingredient in EMPAVELI is pegcetacoplan. One supplier is listed for this compound. Additional details are available on the pegcetacoplan profile page.

DrugPatentWatch® Generic Entry Outlook for Empaveli

Empaveli 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 April 9, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for EMPAVELI
International Patents:144
US Patents:10
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for EMPAVELI
What excipients (inactive ingredients) are in EMPAVELI?EMPAVELI excipients list
DailyMed Link:EMPAVELI at DailyMed
Drug patent expirations by year for EMPAVELI
Drug Prices for EMPAVELI

See drug prices for EMPAVELI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EMPAVELI
Generic Entry Date for EMPAVELI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*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 EMPAVELI
Drug ClassComplement Inhibitor
Mechanism of ActionComplement Inhibitors

US Patents and Regulatory Information for EMPAVELI

EMPAVELI is protected by fifteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EMPAVELI 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 EMPAVELI

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 ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN

Dosing regimens and related compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN

Dosing regimens and related compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS

Dosing regimens and related compositions and methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY

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 ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY 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 ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN SO AS TO REDUCE THE SENSITIVITY OF CELLS TO COMPLEMENT-DEPENDENT DAMAGE


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY

Potent compstatin analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compstatin analogs with improved activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Potent compstatin analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF COMPLEMENT INHIBITOR PEGCETACOPLAN

FDA Regulatory Exclusivity protecting EMPAVELI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
Exclusivity Expiration: ⤷  Sign Up

INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308
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 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 ⤷  Sign Up
Apellis Pharms EMPAVELI pegcetacoplan SOLUTION;SUBCUTANEOUS 215014-001 May 14, 2021 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 EMPAVELI

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 EMPAVELI

When does loss-of-exclusivity occur for EMPAVELI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 18249627
Patent: Dosing regimens and related compositions and methods
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2019020955
Patent: regimes de dosagem e composições e métodos relacionados
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 59304
Patent: SCHEMAS POSOLOGIQUES ET COMPOSITIONS ET PROCEDES ASSOCIES (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 0831544
Patent: 给药方案以及相关组合物和方法 (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Patent: 6059313
Patent: 给药方案以及相关组合物和方法 (Dosing regimens and related compositions and methods)
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 06465
Patent: SCHÉMAS POSOLOGIQUES ET COMPOSITIONS ET PROCÉDÉS ASSOCIÉS (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9844
Patent: משטרי מינון ותכשירים קשורים ושיטות (Dosing regimens and related compositions and methods)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 20516607
Patent: 投与レジメンならびに関連組成物および方法
Estimated Expiration: ⤷  Sign Up

Patent: 23100641
Patent: 投与レジメンならびに関連組成物および方法 (DOSING REGIMENS, AND RELATED COMPOSITIONS AND METHODS)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 19012033
Patent: REGÍMENES DE DOSIFICACIÓN Y COMPOSICIONES Y MÉTODOS RELACIONADOS. (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS.)
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 19131869
Patent: CХЕМЫ ВВЕДЕНИЯ И СВЯЗАННЫЕ КОМПОЗИЦИИ И СПОСОБЫ
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 190139931
Patent: 투여 요법 및 관련 조성물 및 방법
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 EMPAVELI around the world.

Country Patent Number Title Estimated Expiration
Denmark 1549333 ⤷  Sign Up
Denmark 1960422 ⤷  Sign Up
Australia 2003275075 COMPSTATIN ANALOGS WITH IMPROVED ACTIVITY ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMPAVELI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3660033 PA2022010 Lithuania ⤷  Sign Up PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
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.