Zilbrysq is a drug owned by Ucb Inc. It is protected by 9 US drug patents filed from 2023 to 2024 out of which none have expired yet. Zilbrysq's patents will be open to challenges from 18 October, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 12, 2035. Details of Zilbrysq'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. | |||
| US11014965 | Modulation of complement activity |
Jun, 2035
(10 years from now) | Active |
| US10435438 | Modulation of complement activity |
Jun, 2035
(10 years from now) | Active |
| US10208089 | Modulation of complement activity |
Jun, 2035
(10 years from now) | Active |
| US10106579 | Modulation of complement activity |
Jun, 2035
(10 years from now) | Active |
| US10562934 | Modulation of complement activity |
Jun, 2035
(10 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). | |||
| US11752190 | Modulators of complement activity |
Jun, 2035
(10 years from now) | Active |
| US11535650 | Modulation of complement activity |
Jun, 2035
(10 years from now) | Active |
| US10835574 | Modulators of complement activity |
Jun, 2035
(10 years from now) | Active |
| US11965040 | Modulation of complement activity |
Jun, 2035
(10 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 Zilbrysq's patents.
Latest Legal Activities on Zilbrysq's Patents
Given below is the list of recent legal activities going on the following patents of Zilbrysq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10562934 |
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10106579 |
| Second letter to regulating agency to determine regulatory review period | 22 May, 2024 | US10208089 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 May, 2024 | US10835574 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US10208089 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US10106579 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US10562934 |
| Letter from FDA or Dept of Agriculture re PTE application | 17 Apr, 2024 | US10835574 |
| Initial letter Re: PTE Application to regulating agency | 11 Jan, 2024 | US10106579 |
| Initial letter Re: PTE Application to regulating agency | 11 Jan, 2024 | US10208089 |
FDA has granted several exclusivities to Zilbrysq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zilbrysq, 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 Zilbrysq.
Exclusivity Information
Zilbrysq holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Zilbrysq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 17, 2028 |
| Orphan Drug Exclusivity(ODE-446) | Oct 17, 2030 |
US patents provide insights into the exclusivity only within the United States, but Zilbrysq 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 Zilbrysq's family patents as well as insights into ongoing legal events on those patents.
Zilbrysq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zilbrysq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 12, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zilbrysq Generics:
There are no approved generic versions for Zilbrysq as of now.
About Zilbrysq
Zilbrysq is a drug owned by Ucb Inc. It is used for treating generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive by subcutaneously administering the C5 complement inhibitor zilucoplan. Zilbrysq uses Zilucoplan Sodium as an active ingredient. Zilbrysq was launched by Ucb Inc in 2023.
Approval Date:
Zilbrysq was approved by FDA for market use on 17 October, 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 Zilbrysq is 17 October, 2023, its NCE-1 date is estimated to be 18 October, 2027.
Active Ingredient:
Zilbrysq uses Zilucoplan Sodium as the active ingredient. Check out other Drugs and Companies using Zilucoplan Sodium ingredient
Treatment:
Zilbrysq is used for treating generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive by subcutaneously administering the C5 complement inhibitor zilucoplan.
Dosage:
Zilbrysq is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | SOLUTION | Prescription | SUBCUTANEOUS |