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Last Updated: June 26, 2022

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 eight patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in twenty-three countries.

The generic ingredient in EMPAVELI is pegcetacoplan. 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:129
US Patents:8
Applicants:1
NDAs:1
What excipients (inactive ingredients) are in EMPAVELI?EMPAVELI excipients list
DailyMed Link:EMPAVELI at DailyMed
Drug patent expirations by year for EMPAVELI
DrugPatentWatch® Estimated Generic Entry Opportunity 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.

US Patents and Regulatory Information for EMPAVELI

EMPAVELI is protected by eleven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EMPAVELI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN

Dosing regimens and related compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Potent compstatin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compstatin analogs with improved activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Potent compstatin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Apellis Pharms EMPAVELI pegcetacoplan SOLUTION;SUBCUTANEOUS 215014-001 May 14, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Apellis Pharms EMPAVELI pegcetacoplan SOLUTION;SUBCUTANEOUS 215014-001 May 14, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2019020955
Estimated Expiration: See Plans and Pricing

Canada

Patent: 59304
Estimated Expiration: See Plans and Pricing

China

Patent: 0831544
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 06465
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9844
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20516607
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 19012033
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 19131869
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190139931
Estimated Expiration: See Plans and Pricing

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
Japan 6522337 See Plans and Pricing
China 102977191 Potent C3 complement statin analogs See Plans and Pricing
Portugal 3660033 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
McKinsey
Express Scripts
AstraZeneca
Moodys

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.