Nitazoxanide Patent Expiration
Nitazoxanide is Used for treating parasitic infections, including Cryptosporidium parvum, in immunocompromised mammals. It was first introduced by Romark Laboratories
Nitazoxanide Patents
Given below is the list of patents protecting Nitazoxanide, 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 |
|---|---|---|---|---|
| Alinia | US5965590 | Method for treatment of opportunistic infections with pharmaceutical compositions of tizoxanide and nitazoxanide |
Jul 03, 2017
(Expired) | Romark |
| Alinia | US5968961 | Pharmaceutical compositions of tizoxanide and nitazoxanide |
May 07, 2017
(Expired) | Romark |
| Alinia | US6117894 | Acid stabilized pharmaceutical compositions of tizoxanide and nitazoxanide |
May 07, 2017
(Expired) | Romark |
| Alinia | US6020353 | 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide |
Sep 18, 2014
(Expired) | Romark |
| Alinia | US5578621 | Benzamide derivatives |
Sep 08, 2014
(Expired) | Romark |
| Alinia | US6020353 | 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide |
Sep 08, 2014
(Expired) | Romark |
| Alinia | US5578621 | Benzamide derivatives |
Nov 26, 2013
(Expired) | Romark |
Nitazoxanide's Family Patents
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Clinical Trials
Recent Clinical Trials on Nitazoxanide:
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 |
|---|---|---|---|---|
| ||||
| Nitazoxanide in Spontaneous Bacterial Peritonitis | Tanta University | NA |
NOT YET RECRUITING
(Sep 1, 2026)
| PHASE1, PHASE2 |
| Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis | Tanta University | NA |
NOT YET RECRUITING
(Sep 1, 2026)
| PHASE2, PHASE3 |
| Nitazoxanide for Treatment of Cryptosporidium in Children | Johns Hopkins Bloomberg School of Public Health | NA |
NOT YET RECRUITING
(Jul 1, 2026)
| PHASE3 |
| A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD | University of Calgary | NA |
NOT YET RECRUITING
(Jul 1, 2026)
| PHASE2 |