Pegcetacoplan Patent Expiration

Pegcetacoplan is used for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by reducing sensitivity to complement-dependent damage. It was first introduced by Apellis Pharmaceuticals Inc in its drug Empaveli on May 14, 2021. Another drug containing Pegcetacoplan is Syfovre.


Pegcetacoplan Patents

Given below is the list of patents protecting Pegcetacoplan, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Empaveli US12290566 Dosing regimens and related compositions and methods Dec 14, 2038 Apellis Pharms
Syfovre US12458695 Dosing Regimens And Related Compositions And Methods Dec 14, 2038 Apellis Pharms
Empaveli US11844841 Dosing regimens and related compositions and methods Dec 09, 2038 Apellis Pharms
Empaveli US11040107 Dosing regimens and related compositions and methods Apr 09, 2038 Apellis Pharms
Syfovre US11903994 Dosing regimens Feb 22, 2037 Apellis Pharms
Syfovre US12528836 Dosing Regimens Oct 07, 2036 Apellis Pharms
Empaveli US10035822 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Nov 15, 2033 Apellis Pharms
Empaveli US10875893 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Nov 15, 2033 Apellis Pharms
Empaveli US11292815 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Nov 15, 2033 Apellis Pharms
Syfovre US10035822 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Nov 15, 2033 Apellis Pharms
Syfovre US10875893 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Nov 15, 2033 Apellis Pharms
Syfovre US11292815 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Nov 15, 2033 Apellis Pharms
Empaveli US10125171 Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Aug 02, 2033 Apellis Pharms
Syfovre US10125171 Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Aug 02, 2033 Apellis Pharms
Empaveli US11661441 Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Jan 13, 2033 Apellis Pharms
Syfovre US11661441 Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Jan 13, 2033 Apellis Pharms
Empaveli US7888323 Potent compstatin analogs Dec 04, 2027 Apellis Pharms
Empaveli US7989589 Compstatin analogs with improved activity Dec 04, 2027 Apellis Pharms
Syfovre US7888323 Potent compstatin analogs Dec 04, 2027 Apellis Pharms
Syfovre US7989589 Compstatin analogs with improved activity Dec 04, 2027 Apellis Pharms
Empaveli US9169307 Potent compstatin analogs Nov 18, 2027 Apellis Pharms
Syfovre US9169307 Potent compstatin analogs Nov 18, 2027 Apellis Pharms
Syfovre US8168584 Methods of treating age-related macular degeneration by compstatin and analogs thereof Apr 07, 2027 Apellis Pharms
Syfovre US9056076 Method of treating age-related macular degeneration comprising administering a compstatin analog Oct 25, 2026 Apellis Pharms



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Pegcetacoplan's patents.

Given below is the list recent legal activities going on the following patents of Pegcetacoplan.

Activity Date Patent Number
Patent litigations
Mail Patent eGrant Notification 20 Feb, 2024 US11903994
Sequence Moved to Public Database 20 Feb, 2024 US11903994
Patent Issue Date Used in PTA Calculation 20 Feb, 2024 US11903994
Email Notification 20 Feb, 2024 US11903994
Recordation of Patent eGrant 20 Feb, 2024 US11903994
Recordation of Patent Grant Mailed 20 Feb, 2024 US11903994
Patent eGrant Notification 20 Feb, 2024 US11903994
Email Notification 01 Feb, 2024 US11903994
Issue Notification Mailed 31 Jan, 2024 US11903994
Application Is Considered Ready for Issue 22 Jan, 2024 US11903994


Pegcetacoplan's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pegcetacoplan:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation Apellis Pharmaceuticals, Inc. NA WITHDRAWN
(Aug 1, 2026)
PHASE3
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD Apellis Pharmaceuticals, Inc. NA COMPLETED
(Jun 1, 2026)
PHASE3
A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio Apellis Pharmaceuticals, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy Boehringer Ingelheim NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Safely Quenching Complement in Stroke Survivors Columbia University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN Apellis Pharmaceuticals, Inc. NA COMPLETED
(Mar 1, 2026)
PHASE2
APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion Roswell Park Cancer Institute NA RECRUITING
(Mar 1, 2026)
PHASE2


Pegcetacoplan Generic API Manufacturers

Given below is the list of companies who have filed for Pegcetacoplan generic, along with the locations of their manufacturing plants worldwide.