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 one branded drug marketed by Apellis Pharms and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pegcetacoplan has one hundred and thirty-five patent family members in twenty-four countries.
Summary for pegcetacoplan
| International Patents: | 135 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 18 |
| What excipients (inactive ingredients) are in pegcetacoplan? | pegcetacoplan excipients list |
| DailyMed Link: | pegcetacoplan at DailyMed |
Recent Clinical Trials for pegcetacoplan
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Swedish Orphan Biovitrum | Phase 2 |
| Swedish Orphan Biovitrum | Phase 3 |
| Roswell Park Cancer Institute | Phase 2 |
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 | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 | ||
| Apellis Pharms | EMPAVELI | pegcetacoplan | SOLUTION;SUBCUTANEOUS | 215014-001 | May 14, 2021 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 | 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 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 |
|---|---|---|---|
| Croatia | P20211342 | See Plans and Pricing | |
| Russian Federation | 2012147267 | ЭФФЕКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА | See Plans and Pricing |
| Hong Kong | 1156862 | COMPSTATIN ANALOGS WITH IMPROVED ACTIVITY | See Plans and Pricing |
| Russian Federation | 2474586 | ЭФФЕКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА (EFFICIENT COMPSTATIN ANALOGUES) | See Plans and Pricing |
| Japan | 4614222 | See Plans and Pricing | |
| Serbia | 62243 | ANALOZI KOMPSTATINA SA PRODUŽENIM TRAJANJEM DEJSTVA I NJIHOVE KOMPOZICIJE I POSTUPCI (LONG-ACTING COMPSTATIN ANALOGS AND RELATED COMPOSITIONS AND METHODS) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pegcetacoplan
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3660033 | 122022000034 | Germany | See Plans and Pricing | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211213 |
| 3660033 | PA2022010 | Lithuania | See Plans and Pricing | PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213 |
| 3660033 | CA 2022 00023 | Denmark | See Plans and Pricing | PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214 |
| 3660033 | 301178 | Netherlands | See Plans and Pricing | PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214 |
| 3660033 | 2022C/522 | Belgium | See Plans and Pricing | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
| 3660033 | LUC00265 | Luxembourg | See Plans and Pricing | PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
