Zepzelca is a drug owned by Jazz Pharmaceuticals Ireland Ltd. It is protected by 1 US drug patent filed in 2020 out of which none have expired yet. Zepzelca's patents have been open to challenges since 15 June, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 13, 2029. Details of Zepzelca'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. | |||
| US7763615 | Ecteinascidin analogs for use as antitumour agents |
Dec, 2029
(4 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 Zepzelca's patents.
Latest Legal Activities on Zepzelca's Patents
Given below is the list of recent legal activities going on the following patents of Zepzelca.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 17 Oct, 2023 | US7763615 |
| Electronic Review Critical | 06 Jun, 2023 | US7763615 |
| Notice of Final Determination -Eligible | 15 May, 2023 | US7763615 |
| Notice of Final Determination -Eligible | 25 Jan, 2023 | US7763615 |
| FDA Final Eligibility Letter Critical | 29 Aug, 2022 | US7763615 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jan, 2022 | US7763615 |
| transaction for FDA Determination of Regulatory Review Period | 05 Nov, 2021 | US7763615 |
| Second letter to regulating agency to determine regulatory review period | 20 May, 2021 | US7763615 |
| Letter from FDA or Dept of Agriculture re PTE application | 14 Dec, 2020 | US7763615 |
| Initial letter Re: PTE Application to regulating agency | 17 Nov, 2020 | US7763615 |
FDA has granted several exclusivities to Zepzelca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zepzelca, 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 Zepzelca.
Exclusivity Information
Zepzelca holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zepzelca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 15, 2025 |
| Orphan Drug Exclusivity(ODE-304) | Jun 15, 2027 |
US patents provide insights into the exclusivity only within the United States, but Zepzelca 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 Zepzelca's family patents as well as insights into ongoing legal events on those patents.
Zepzelca's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zepzelca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 13, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zepzelca Generics:
There are no approved generic versions for Zepzelca as of now.
About Zepzelca
Zepzelca is a drug owned by Jazz Pharmaceuticals Ireland Ltd. It is used for treating small cell lung cancer in adult patients who have progressed on or after platinum-based chemotherapy. Zepzelca uses Lurbinectedin as an active ingredient. Zepzelca was launched by Jazz in 2020.
Approval Date:
Zepzelca was approved by FDA for market use on 15 June, 2020.
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 Zepzelca is 15 June, 2020, its NCE-1 date is estimated to be 15 June, 2024.
Active Ingredient:
Zepzelca uses Lurbinectedin as the active ingredient. Check out other Drugs and Companies using Lurbinectedin ingredient
Treatment:
Zepzelca is used for treating small cell lung cancer in adult patients who have progressed on or after platinum-based chemotherapy.
Dosage:
Zepzelca is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG/VIAL | POWDER | Prescription | INTRAVENOUS |