Libervant is a drug owned by Aquestive Therapeutics Inc. It is protected by 1 US drug patent 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 18, 2038. Details of Libervant's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11273131 | Pharmaceutical compositions with enhanced permeation |
Jun, 2038
(13 years from now) | Active |
FDA has granted several exclusivities to Libervant. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Libervant, 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 Libervant.
Exclusivity Information
Libervant holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Libervant's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 26, 2027 |
US patents provide insights into the exclusivity only within the United States, but Libervant 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 Libervant's family patents as well as insights into ongoing legal events on those patents.
Libervant's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Libervant's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 18, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Libervant Generics:
Diazepam is the generic name for the brand Libervant. 34 different companies have already filed for the generic of Libervant, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Libervant's generic
Libervant Competitors
Understanding your competition is essential for market success. There are several other brand drugs using the same active ingredient (Diazepam) as Libervant. 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 | ||
|---|---|---|---|
| Bausch |
| ||
| Neurelis Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diazepam, Libervant's active ingredient. Check the complete list of approved generic manufacturers for Libervant
About Libervant
Libervant is a drug owned by Aquestive Therapeutics Inc. Libervant uses Diazepam as an active ingredient. Libervant was launched by Aquestive in 2024.
Approval Date:
Libervant was approved by FDA for market use on 26 April, 2024.
Active Ingredient:
Libervant uses Diazepam as the active ingredient. Check out other Drugs and Companies using Diazepam ingredient
Dosage:
Libervant is available in film form for buccal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | FILM | Prescription | BUCCAL |
| 5MG | FILM | Prescription | BUCCAL |
| 7.5MG | FILM | Prescription | BUCCAL |
| 10MG | FILM | Prescription | BUCCAL |
| 12.5MG | FILM | Prescription | BUCCAL |