Syfovre Patent Expiration

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

(9 years from now)

Active
US11292815 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Nov, 2033

(9 years from now)

Active
US10035822 Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Nov, 2033

(9 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
US7989589 Compstatin analogs with improved activity
Dec, 2027

(3 years from now)

Active
US7888323 Potent compstatin analogs
Dec, 2027

(3 years from now)

Active
US9169307 Potent compstatin analogs
Nov, 2027

(3 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

(2 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 Syfovre's patents.

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

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


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

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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

Syfovre has patent protection in a total of 24 countries. It's US patent count contributes only to 29.9% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Syfovre.

Family Patents

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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
Empaveli






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


Syfovre News

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02 Aug, 2024

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