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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Nitazoxanide Generic API Manufacturers
Several generic applications have been filed for Nitazoxanide. The first generic version for Nitazoxanide was by Rising Pharma Holdings Inc and was approved on Nov 27, 2020. And the latest generic version is by Annora Pharma Private Ltd and was approved on Apr 15, 2025.
Given below is the list of companies who have filed for Nitazoxanide generic, along with the locations of their manufacturing plants worldwide.
1. ANI PHARMS
Ani Pharmaceuticals Inc has filed for 1 generic for Nitazoxanide. Given below are the details of the strengths of this generic introduced by Ani Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Feb 3, 2025 |
2. ANNORA PHARMA
Annora Pharma Private Ltd has filed for 1 generic for Nitazoxanide. Given below are the details of the strengths of this generic introduced by Annora Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Apr 15, 2025 |
Manufacturing Plant Locations New
Annora Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
3. RISING
Rising Pharma Holdings Inc has filed for 1 generic for Nitazoxanide. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG
(reference standard) | tablet | Prescription | ORAL | AB | Nov 27, 2020 |
Manufacturing Plant Locations New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Mexico |
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| India |
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