Diazepam Patent Expiration
Diazepam was first introduced by Hoffmann La Roche Inc
Diazepam Patents
Given below is the list of patents protecting Diazepam, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Valtoco | US12599611 | Methods And Compositions For Treating Seizure Disorders In Pediatric Patients | Jun 10, 2042 | Neurelis Inc |
| Libervant | US11273131 | Pharmaceutical compositions with enhanced permeation | Jun 18, 2038 | Aquestive |
| Valtoco | US12324852 | Administration of benzodiazepine compositions | Oct 16, 2032 | Neurelis Inc |
| Valtoco | US12337061 | Administration of benzodiazepine compositions | Jun 13, 2032 | Neurelis Inc |
| Valtoco | US11241414 | Administration of benzodiazepine compositions | Mar 27, 2029 | Neurelis Inc |
| Valtoco | US11793786 | Administration of benzodiazepine compositions | Mar 27, 2029 | Neurelis Inc |
| Valtoco | US12268664 | Administration of benzodiazepine compositions | Mar 27, 2029 | Neurelis Inc |
| Valtoco | US12521400 | Administration Of Benzodiazepine Compositions | Mar 27, 2029 | Neurelis Inc |
| Valtoco | US8895546 | Administration of benzodiazepine compositions | Mar 27, 2029 | Neurelis Inc |
| Valtoco | US9763876 | Administration of benzodiazepine compositions | Mar 27, 2029 | Neurelis Inc |
| Valtoco | US8927497 | Absorption enhancers for intranasal administration |
Jul 21, 2025
(Expired) | Neurelis Inc |
| Valtoco | US10265402 | Absorption enhancers for drug administration |
May 11, 2025
(Expired) | Neurelis Inc |
| Valtoco | US9642913 | Pharmaceutical composition including alkyl glycoside and an anti-seizure agent |
May 11, 2025
(Expired) | Neurelis Inc |
| Diastat | US5462740 | Rectally-administered, epileptic-seizure-inhibiting composition |
Sep 17, 2013
(Expired) | Bausch |
| Diastat Acudial | US5462740 | Rectally-administered, epileptic-seizure-inhibiting composition |
Sep 17, 2013
(Expired) | Bausch |
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 Diazepam's patents.
Latest Legal Activities on Diazepam's Patents
Given below is the list recent legal activities going on the following patents of Diazepam.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 27 Oct, 2025 | US9763876 |
| Request for Trial Granted | 16 Sep, 2025 | US11241414 |
| Request for Trial Granted | 16 Sep, 2025 | US8895546 |
| Request for Trial Granted | 16 Sep, 2025 | US11793786 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jul, 2025 | US11241414 |
| Maintenance Fee Reminder Mailed | 12 May, 2025 | US9763876 |
| Petition Requesting Trial | 17 Jan, 2025 | US11241414 |
| Petition Requesting Trial | 17 Jan, 2025 | US11793786 |
| Petition Requesting Trial | 17 Jan, 2025 | US8895546 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Oct, 2024 | US9642913 |
Diazepam's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Diazepam:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| The TTM and ASM Trial | National Taiwan University Hospital | NA |
NOT YET RECRUITING
(Aug 1, 2026)
| PHASE1 |
| MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) | Sixth Affiliated Hospital, Sun Yat-sen University | NA |
NOT YET RECRUITING
(Apr 1, 2026)
| PHASE2, PHASE3 |