Aqneursa is a drug owned by Intrabio Inc. It is protected by 3 US drug patents filed in 2025 out of which none have expired yet. Aqneursa's patents will be open to challenges from 24 September, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 19, 2037. Details of Aqneursa'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). | |||
| US11400067 | Pharmaceutical compositions and uses directed to lysosomal storage disorders |
Apr, 2037
(11 years from now) | Active |
| US12433863 | Pharmaceutical Compositions And Uses Directed To Lysosomal Storage Disorders |
Apr, 2037
(11 years from now) | Active |
| US12433862 | Pharmaceutical Compositions And Uses Directed To Lysosomal Storage Disorders |
Apr, 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 Aqneursa's patents.
Latest Legal Activities on Aqneursa's Patents
Given below is the list of recent legal activities going on the following patents of Aqneursa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Application Is Considered Ready for Issue | 13 Aug, 2025 | US12433863 |
| Dispatch to FDC | 13 Aug, 2025 | US12433863 |
| Dispatch to FDC | 07 Aug, 2025 | US12433862 |
| Application Is Considered Ready for Issue | 07 Aug, 2025 | US12433862 |
| Issue Fee Payment Received | 06 Aug, 2025 | US12433863 |
| Issue Fee Payment Verified | 06 Aug, 2025 | US12433862 |
| Issue Fee Payment Received | 06 Aug, 2025 | US12433862 |
| Issue Fee Payment Verified | 06 Aug, 2025 | US12433863 |
| Mail Notice of Allowance | 29 Jul, 2025 | US12433862 |
| Mail Notice of Allowance | 29 Jul, 2025 | US12433863 |
FDA has granted several exclusivities to Aqneursa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Aqneursa, 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
Aqneursa.
Exclusivity Information
Aqneursa holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Aqneursa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 24, 2029 |
| Orphan Drug Exclusivity(ODE-498) | Sep 24, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Aqneursa 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 Aqneursa's family patents as well as insights into
ongoing legal events
on those patents.
Aqneursa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aqneursa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 19, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aqneursa Generics:
There are no approved generic versions for Aqneursa as of now.
About Aqneursa
Aqneursa is a drug owned by Intrabio Inc. Aqneursa uses Levacetylleucine as an active ingredient. Aqneursa was launched by Intrabio in 2024.
Approval Date:
Aqneursa was approved by FDA for market use on 24 September, 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 Aqneursa is 24 September, 2024, its NCE-1 date is estimated to be 24 September, 2028.
Active Ingredient:
Aqneursa uses Levacetylleucine as the active ingredient. Check out other Drugs and Companies using Levacetylleucine ingredient
Dosage:
Aqneursa is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM/PACKET | FOR SUSPENSION | Prescription | ORAL |