Lumryz is a drug owned by Avadel Cns Pharmaceuticals Llc. It is protected by 31 US drug patents filed from 2023 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 16, 2042. Details of Lumryz'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). | |||
| US11779557 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Mar, 2042
(16 years from now) | Active |
| US11583510 | Methods of administering gamma hydroxybutyrate formulations after a high-fat meal |
Feb, 2042
(16 years from now) | Active |
| US10925844 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state |
Feb, 2040
(14 years from now) | Active |
| US11400065 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state |
Jul, 2037
(11 years from now) | Active |
| US12128021 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11602512 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US10952986 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11000498 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12109186 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11602513 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11986451 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11826335 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12097176 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11896572 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11839597 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11766418 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11065224 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US10272062 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12226377 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state |
Jul, 2037
(11 years from now) | Active |
| US12115143 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12138239 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12115144 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11504347 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US10973795 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12115142 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12115145 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12097175 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12144793 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US11052061 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US10736866 | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Jul, 2037
(11 years from now) | Active |
| US12303478 | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state |
Jul, 2037
(11 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 Lumryz's patents.
Latest Legal Activities on Lumryz's Patents
Given below is the list of recent legal activities going on the following patents of Lumryz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 May, 2024 | US10973795 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Apr, 2024 | US10952986 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Mar, 2024 | US10925844 |
| Recordation of Patent eGrant | 13 Feb, 2024 | US11896572 |
| Patent Issue Date Used in PTA Calculation
Critical | 13 Feb, 2024 | US11896572 |
| Email Notification
Critical | 13 Feb, 2024 | US11896572 |
| Mail Patent eGrant Notification | 13 Feb, 2024 | US11896572 |
| Patent eGrant Notification | 13 Feb, 2024 | US11896572 |
| Recordation of Patent Grant Mailed
Critical | 13 Feb, 2024 | US11896572 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Feb, 2024 | US10736866 (Litigated) |
FDA has granted several exclusivities to Lumryz. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Lumryz, 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
Lumryz.
Exclusivity Information
Lumryz holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Lumryz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 01, 2026 |
| Orphan Drug Exclusivity(ODE-431) | May 01, 2030 |
| Orphan Drug Exclusivity(ODE-494) | Oct 16, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Lumryz 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 Lumryz's family patents as well as insights into
ongoing legal events
on those patents.
Lumryz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lumryz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 16, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lumryz Generic API suppliers:
Sodium Oxybate is the generic name for the brand Lumryz. 2 different companies have already filed for the generic of Lumryz, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lumryz's generic
Alternative Brands for Lumryz
Lumryz which is used for treating narcolepsy, cataplexy, and excessive daytime sleepiness with a gamma-hydroxybutyrate formulation., has several other brand drugs using the same active ingredient (Sodium Oxybate). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sodium Oxybate, Lumryz's active ingredient. Check the complete list of approved generic manufacturers for Lumryz
About Lumryz
Lumryz is a drug owned by Avadel Cns Pharmaceuticals Llc. It is used for treating narcolepsy, cataplexy, and excessive daytime sleepiness with a gamma-hydroxybutyrate formulation. Lumryz uses Sodium Oxybate as an active ingredient. Lumryz was launched by Avadel Cns in 2023.
Approval Date:
Lumryz was approved by FDA for market use on 01 May, 2023.
Active Ingredient:
Lumryz uses Sodium Oxybate as the active ingredient. Check out other Drugs and Companies using Sodium Oxybate ingredient
Treatment:
Lumryz is used for treating narcolepsy, cataplexy, and excessive daytime sleepiness with a gamma-hydroxybutyrate formulation.
Dosage:
Lumryz is available in for suspension, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4.5GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |
| 9GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |
| 7.5GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |
| 6GM/PACKET | FOR SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |