Modafinil Patent Expiration
Modafinil is Used for treating excessive daytime sleepiness associated with narcolepsy. It was first introduced by Nuvo Pharmaceuticals (Ireland) Dac
Modafinil Patents
Given below is the list of patents protecting Modafinil, 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 |
|---|---|---|---|---|
| Provigil |
US7297346 (Pediatric) | Pharmaceutical formulations of modafinil |
May 29, 2024
(Expired) | Nuvo Pharms |
| Provigil | US7297346 | Pharmaceutical formulations of modafinil |
Nov 29, 2023
(Expired) | Nuvo Pharms |
| Provigil |
USRE37516 (Pediatric) | Acetamide derivative having defined particle size |
Apr 06, 2015
(Expired) | Nuvo Pharms |
| Provigil | USRE37516 | Acetamide derivative having defined particle size |
Oct 06, 2014
(Expired) | Nuvo Pharms |
Modafinil's Family Patents
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Clinical Trials
Recent Clinical Trials on Modafinil:
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 |
|---|---|---|---|---|
 | ||||
| Modafinil to Improve Fatiguability | Ottawa Hospital Research Institute | NA |
RECRUITING
(Jul 1, 2026)
| PHASE1, PHASE2 |
| Cognitive Strategies in Early Psychosis 2 | University of Minnesota | NA |
RECRUITING
(Jul 1, 2026)
| PHASE3 |
| RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) | Duke University | NA |
COMPLETED
(May 1, 2026)
| PHASE2 |
| Psilocybin Therapy for Chronic Low Back Pain | Joshua Woolley, MD, PhD | NA |
ACTIVE NOT RECRUITING
(Apr 1, 2026)
| PHASE1, PHASE2 |
| Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial) | Radboud University Medical Center | NA |
RECRUITING
(Apr 1, 2026)
| PHASE2, PHASE3 |