empaveli Drug Patent Profile
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Which patents cover Empaveli, and what generic alternatives are available?
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-two patent family members in twenty-five 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
Summary for empaveli
International Patents: | 142 |
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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for empaveli
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 ⤷ 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 empaveli
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 ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN
Dosing regimens and related compositions and methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compstatin analogs with improved activity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Potent compstatin analogs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
Exclusivity Expiration: ⤷ Try a Trial
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308
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 | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 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: ⤷ Try a Trial
Brazil
Patent: 2019020955
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 59304
Estimated Expiration: ⤷ Try a Trial
China
Patent: 0831544
Estimated Expiration: ⤷ Try a Trial
Patent: 6059313
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 06465
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9844
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 20516607
Estimated Expiration: ⤷ Try a Trial
Patent: 23100641
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 19012033
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 19131869
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 190139931
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 empaveli around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 366404 | ANALOGOS DE COMPSTATINA DE CELULA REACTIVA, DE ACCIÓN PROLONGADA U OBJETIVOS Y COMPOSICIONES Y METODOS RELACIONADOS. (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS.) | ⤷ Try a Trial |
European Patent Office | 3606465 | SCHÉMAS POSOLOGIQUES ET COMPOSITIONS ET PROCÉDÉS ASSOCIÉS (DOSING REGIMENS AND RELATED COMPOSITIONS AND METHODS) | ⤷ Try a Trial |
Spain | 2879430 | ⤷ Try a Trial | |
Japan | 2014514364 | ⤷ Try a Trial | |
Israel | 191674 | אנלוגים פוטנטים של קומפסטטין (Potent compstatin analogs) | ⤷ Try a Trial |
Austria | 525082 | ⤷ Try a Trial | |
Norway | 2022017 | ⤷ Try a 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 | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214 |
3660033 | 122022000034 | Germany | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211213 |
3660033 | LUC00265 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
3660033 | 22C1025 | France | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214 |
3660033 | C202230025 | Spain | ⤷ Try a Trial | 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 | 2022017 | Norway | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216 |
3660033 | PA2022010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |