Zepbound is a drug owned by Eli Lilly And Co. It is protected by 3 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2039. Details of Zepbound's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9474780 | GIP and GLP-1 co-agonist compounds |
Jan, 2036
(11 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11357820 | GIP/GLP1 agonist compositions |
Jun, 2039
(14 years from now) | Active |
| US11918623 | GIP/GLP1 agonist compositions |
Jun, 2039
(14 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 Zepbound's patents.
Latest Legal Activities on Zepbound's Patents
Given below is the list of recent legal activities going on the following patents of Zepbound.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 05 Mar, 2024 | US11918623 |
| Email Notification | 05 Mar, 2024 | US11918623 |
| Mail Patent eGrant Notification | 05 Mar, 2024 | US11918623 |
| Recordation of Patent Grant Mailed | 05 Mar, 2024 | US11918623 |
| Patent eGrant Notification | 05 Mar, 2024 | US11918623 |
| Recordation of Patent eGrant | 05 Mar, 2024 | US11918623 |
| Email Notification | 15 Feb, 2024 | US11918623 |
| Issue Notification Mailed | 14 Feb, 2024 | US11918623 |
| Dispatch to FDC | 31 Jan, 2024 | US11918623 |
| Application Is Considered Ready for Issue | 31 Jan, 2024 | US11918623 |
FDA has granted several exclusivities to Zepbound. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zepbound, 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 Zepbound.
Exclusivity Information
Zepbound holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zepbound's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 08, 2026 |
| New Chemical Entity Exclusivity(NCE) | May 13, 2027 |
US patents provide insights into the exclusivity only within the United States, but Zepbound 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 Zepbound's family patents as well as insights into ongoing legal events on those patents.
Zepbound's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response 🥳
Generic Launch
Generic Release Date:
Zepbound's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zepbound Generics:
There are no approved generic versions for Zepbound as of now.
About Zepbound
Zepbound is a drug owned by Eli Lilly And Co. Zepbound uses Tirzepatide as an active ingredient. Zepbound was launched by Eli Lilly And Co in 2024.
Market Authorisation Date:
Zepbound was approved by FDA for market use on 28 March, 2024.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Zepbound is 28 March, 2024, its NCE-1 date is estimated to be 13 May, 2026
Active Ingredient:
Zepbound uses Tirzepatide as the active ingredient. Check out other Drugs and Companies using Tirzepatide ingredient
Dosage:
Zepbound is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 10MG/0.5ML (10MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 7.5MG/0.5ML (7.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 15MG/0.5ML (15MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 5MG/0.5ML (5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 12.5MG/0.5ML (12.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |