Livdelzi is a drug owned by Gilead Sciences Inc. It is protected by 6 US drug patents filed in 2024 out of which none have expired yet. Livdelzi's patents will be open to challenges from 14 August, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 19, 2035. Details of Livdelzi'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. | |||
| US7709682 | Lysine salts of 4-((phenoxyalkyl)thio)-phenoxyacetic acid derivatives |
Sep, 2026
(1 year, 9 months from now) | Active |
| US7301050 | 4-((phenoxyalkyl)thio)-phenoxyacetic acids and analogs |
Aug, 2025
(8 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11596614 | Treatment of intrahepatic cholestatic diseases |
Mar, 2035
(10 years from now) | Active |
| US11406611 | Treatment of intrahepatic cholestatic diseases |
Mar, 2035
(10 years from now) | Active |
| US10272058 | Treatment of intrahepatic cholestatic diseases |
Mar, 2035
(10 years from now) | Active |
| US9486428 | Treatment of intrahepatic cholestatic diseases |
Mar, 2035
(10 years from now) | Active |
FDA has granted several exclusivities to Livdelzi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Livdelzi, 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 Livdelzi.
Exclusivity Information
Livdelzi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Livdelzi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 14, 2029 |
| Orphan Drug Exclusivity(ODE-486) | Aug 14, 2031 |
US patents provide insights into the exclusivity only within the United States, but Livdelzi 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 Livdelzi's family patents as well as insights into ongoing legal events on those patents.
Livdelzi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Livdelzi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 19, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Livdelzi Generics:
There are no approved generic versions for Livdelzi as of now.
Alternative Brands for Livdelzi
There are several other brand drugs in the same treatment category as Livdelzi. 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 | Treatment Area | ||
|---|---|---|---|---|
| Intercept Pharms Inc |
| |||
About Livdelzi
Livdelzi is a drug owned by Gilead Sciences Inc. Livdelzi uses Seladelpar Lysine as an active ingredient. Livdelzi was launched by Gilead Sciences Inc in 2024.
Approval Date:
Livdelzi was approved by FDA for market use on 14 August, 2024.
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 Livdelzi is 14 August, 2024, its NCE-1 date is estimated to be 14 August, 2028.
Active Ingredient:
Livdelzi uses Seladelpar Lysine as the active ingredient. Check out other Drugs and Companies using Seladelpar Lysine ingredient
Dosage:
Livdelzi is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | CAPSULE | Prescription | ORAL |