Empaveli is a drug owned by Apellis Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2021 to 2025 out of which none have expired yet. Empaveli's patents have been open to challenges since 14 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 14, 2038. Details of Empaveli's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10035822 | Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods |
Nov, 2033
(8 years from now) | Active |
| US11292815 | Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods |
Nov, 2033
(8 years from now) | Active |
| US10875893 | Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods |
Nov, 2033
(8 years from now) | Active |
| US10125171 | Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof |
Aug, 2033
(8 years from now) | Active |
| US11661441 | Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof |
Jan, 2033
(7 years from now) | Active |
| US7888323 | Potent compstatin analogs |
Dec, 2027
(2 years from now) | Active |
| US7989589 | Compstatin analogs with improved activity |
Dec, 2027
(2 years from now) | Active |
| US9169307 | Potent compstatin analogs |
Nov, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12290566 | Dosing regimens and related compositions and methods |
Dec, 2038
(13 years from now) | Active |
| US11844841 | Dosing regimens and related compositions and methods |
Dec, 2038
(13 years from now) | Active |
| US11040107 | Dosing regimens and related compositions and methods |
Apr, 2038
(12 years from now) | Active |
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 Empaveli's patents.
Latest Legal Activities on Empaveli's Patents
Given below is the list of recent legal activities going on the following patents of Empaveli.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Jul, 2024 | US10875893 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 15 May, 2024 | US10875893 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US10875893 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US10035822 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US10125171 |
| Email Notification Critical | 20 Dec, 2023 | US11844841 |
| Patent Issue Date Used in PTA Calculation Critical | 19 Dec, 2023 | US11844841 |
| Mail Patent eGrant Notification | 19 Dec, 2023 | US11844841 |
| Patent eGrant Notification | 19 Dec, 2023 | US11844841 |
| Recordation of Patent eGrant | 19 Dec, 2023 | US11844841 |
FDA has granted several exclusivities to Empaveli. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Empaveli, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Empaveli.
Exclusivity Information
Empaveli holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Empaveli's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-288) | Feb 08, 2026 |
| New Chemical Entity Exclusivity(NCE) | May 14, 2026 |
| Orphan Drug Exclusivity(ODE-351) | May 14, 2028 |
US patents provide insights into the exclusivity only within the United States, but Empaveli is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Empaveli's family patents as well as insights into ongoing legal events on those patents.
Empaveli's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Empaveli's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 14, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Empaveli Generics:
There are no approved generic versions for Empaveli as of now.
Alternative Brands for Empaveli
Empaveli which is used for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by reducing sensitivity to complement-dependent damage., has several other brand drugs using the same active ingredient (Pegcetacoplan). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Apellis Pharms |
|
About Empaveli
Empaveli is a drug owned by Apellis Pharmaceuticals Inc. It is used for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by reducing sensitivity to complement-dependent damage. Empaveli uses Pegcetacoplan as an active ingredient. Empaveli was launched by Apellis Pharms in 2021.
Approval Date:
Empaveli was approved by FDA for market use on 14 May, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Empaveli is 14 May, 2021, its NCE-1 date is estimated to be 14 May, 2025.
Active Ingredient:
Empaveli uses Pegcetacoplan as the active ingredient. Check out other Drugs and Companies using Pegcetacoplan ingredient
Treatment:
Empaveli is used for treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by reducing sensitivity to complement-dependent damage.
Dosage:
Empaveli is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1080MG/20ML (54MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |