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 eleven patents protecting this drug.
This drug has one hundred and seventy patent family members in twenty-nine 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 was eligible for patent challenges on May 14, 2025.
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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for EMPAVELI?
- What are the global sales for EMPAVELI?
- What is Average Wholesale Price for EMPAVELI?
Summary for EMPAVELI
| International Patents: | 170 |
| US Patents: | 11 |
| 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 |
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 Class | Complement Inhibitor |
| Mechanism of Action | Complement Inhibitors |
US Patents and Regulatory Information for EMPAVELI
EMPAVELI is protected by twenty-seven US patents and six FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EMPAVELI is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 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/005553Aspaveli 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: 13344462
Estimated Expiration: ⤷ Start Trial
Patent: 18247243
Estimated Expiration: ⤷ Start Trial
Patent: 20260435
Estimated Expiration: ⤷ Start Trial
Patent: 23200929
Estimated Expiration: ⤷ Start Trial
Patent: 25201748
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2015011244
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 91673
Estimated Expiration: ⤷ Start Trial
Patent: 47554
Estimated Expiration: ⤷ Start Trial
China
Patent: 5051057
Estimated Expiration: ⤷ Start Trial
Patent: 0882376
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0211342
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 24474
Estimated Expiration: ⤷ Start Trial
Patent: 22015
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 20201
Estimated Expiration: ⤷ Start Trial
Patent: 60033
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 20201
Estimated Expiration: ⤷ Start Trial
Patent: 60033
Estimated Expiration: ⤷ Start Trial
Patent: 29206
Estimated Expiration: ⤷ Start Trial
France
Patent: C1025
Estimated Expiration: ⤷ Start Trial
Hong Kong
Patent: 15445
Estimated Expiration: ⤷ Start Trial
Patent: 17336
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 55564
Estimated Expiration: ⤷ Start Trial
Patent: 200026
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 6004
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 73167
Estimated Expiration: ⤷ Start Trial
Patent: 93871
Estimated Expiration: ⤷ Start Trial
Patent: 41271
Estimated Expiration: ⤷ Start Trial
Patent: 16505527
Estimated Expiration: ⤷ Start Trial
Patent: 19070011
Estimated Expiration: ⤷ Start Trial
Patent: 21107441
Estimated Expiration: ⤷ Start Trial
Patent: 22120193
Estimated Expiration: ⤷ Start Trial
Patent: 24056923
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 60033
Estimated Expiration: ⤷ Start Trial
Patent: 660033
Estimated Expiration: ⤷ Start Trial
Patent: 2022010
Estimated Expiration: ⤷ Start Trial
Luxembourg
Patent: 0265
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 6404
Estimated Expiration: ⤷ Start Trial
Patent: 3350
Estimated Expiration: ⤷ Start Trial
Patent: 15006154
Estimated Expiration: ⤷ Start Trial
Patent: 19007709
Estimated Expiration: ⤷ Start Trial
Netherlands
Patent: 1178
Estimated Expiration: ⤷ Start Trial
Norway
Patent: 22017
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 20201
Estimated Expiration: ⤷ Start Trial
Patent: 60033
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 20201
Estimated Expiration: ⤷ Start Trial
Patent: 60033
Estimated Expiration: ⤷ Start Trial
Russian Federation
Patent: 05215
Estimated Expiration: ⤷ Start Trial
Patent: 15119165
Estimated Expiration: ⤷ Start Trial
San Marino
Patent: 02100514
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 243
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 60033
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 80674
Estimated Expiration: ⤷ Start Trial
Patent: 79430
Estimated Expiration: ⤷ Start 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 EMPAVELI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2013344462 | ⤷ Start Trial | |
| Australia | 2018247243 | ⤷ Start Trial | |
| Australia | 2020260435 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EMPAVELI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3660033 | 301178 | Netherlands | ⤷ Start Trial | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214 |
| 3660033 | PA2022010 | Lithuania | ⤷ Start Trial | PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213 |
| 3660033 | 2022C/522 | Belgium | ⤷ Start Trial | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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