Syfovre is a drug owned by Apellis Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2023 to 2024 out of which none have expired yet. Syfovre's patents will be open to challenges from 14 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 22, 2037. Details of Syfovre'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. | |||
| US10875893 | 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 |
| US10035822 | 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
(8 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). | |||
| US11903994 | Dosing regimens |
Feb, 2037
(12 years from now) | Active |
| US8168584 | Methods of treating age-related macular degeneration by compstatin and analogs thereof |
Apr, 2027
(2 years from now) | Active |
| US9056076 | Method of treating age-related macular degeneration comprising administering a compstatin analog |
Oct, 2026
(1 year, 10 months 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 Syfovre's patents.
Latest Legal Activities on Syfovre's Patents
Given below is the list of recent legal activities going on the following patents of Syfovre.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eGrant Notification | 20 Feb, 2024 | US11903994 |
| Sequence Moved to Public Database | 20 Feb, 2024 | US11903994 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Feb, 2024 | US11903994 |
| Email Notification Critical | 20 Feb, 2024 | US11903994 |
| Recordation of Patent eGrant | 20 Feb, 2024 | US11903994 |
| Recordation of Patent Grant Mailed Critical | 20 Feb, 2024 | US11903994 |
| Patent eGrant Notification | 20 Feb, 2024 | US11903994 |
| Email Notification Critical | 01 Feb, 2024 | US11903994 |
| Issue Notification Mailed Critical | 31 Jan, 2024 | US11903994 |
| Application Is Considered Ready for Issue Critical | 22 Jan, 2024 | US11903994 |
FDA has granted several exclusivities to Syfovre. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Syfovre, 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 Syfovre.
Exclusivity Information
Syfovre holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Syfovre's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 22, 2026 |
| New Chemical Entity Exclusivity(NCE) | May 14, 2026 |
US patents provide insights into the exclusivity only within the United States, but Syfovre 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 Syfovre's family patents as well as insights into ongoing legal events on those patents.
Syfovre's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Syfovre's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 22, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Syfovre Generics:
There are no approved generic versions for Syfovre as of now.
Alternative Brands for Syfovre
Syfovre which is used for treating geographic atrophy secondary to age-related macular degeneration., 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 Syfovre
Syfovre is a drug owned by Apellis Pharmaceuticals Inc. It is used for treating geographic atrophy secondary to age-related macular degeneration. Syfovre uses Pegcetacoplan as an active ingredient. Syfovre was launched by Apellis Pharms in 2023.
Approval Date:
Syfovre was approved by FDA for market use on 17 February, 2023.
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 Syfovre is 17 February, 2023, its NCE-1 date is estimated to be 14 May, 2025.
Active Ingredient:
Syfovre uses Pegcetacoplan as the active ingredient. Check out other Drugs and Companies using Pegcetacoplan ingredient
Treatment:
Syfovre is used for treating geographic atrophy secondary to age-related macular degeneration.
Dosage:
Syfovre is available in solution form for intravitreal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG/0.1ML (15MG/0.1ML) | SOLUTION | Prescription | INTRAVITREAL |