ALINIA Drug Patent Profile
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Which patents cover Alinia, and when can generic versions of Alinia launch?
Alinia is a drug marketed by Romark and is included in two NDAs.
The generic ingredient in ALINIA is nitazoxanide. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nitazoxanide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alinia
A generic version of ALINIA was approved as nitazoxanide by RISING on November 27th, 2020.
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Summary for ALINIA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 18 |
| Patent Applications: | 3,153 |
| Drug Prices: | Drug price information for ALINIA |
| What excipients (inactive ingredients) are in ALINIA? | ALINIA excipients list |
| DailyMed Link: | ALINIA at DailyMed |
Recent Clinical Trials for ALINIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bill and Melinda Gates Foundation | Phase 2/Phase 3 |
| Haydom Lutheran Hospital | Phase 2/Phase 3 |
| University of Virginia | Phase 2/Phase 3 |
Pharmacology for ALINIA
| Drug Class | Antiprotozoal |
US Patents and Regulatory Information for ALINIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Romark | ALINIA | nitazoxanide | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Romark | ALINIA | nitazoxanide | TABLET;ORAL | 021497-001 | Jul 21, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ALINIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Romark | ALINIA | nitazoxanide | TABLET;ORAL | 021497-001 | Jul 21, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Romark | ALINIA | nitazoxanide | TABLET;ORAL | 021497-001 | Jul 21, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Romark | ALINIA | nitazoxanide | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Romark | ALINIA | nitazoxanide | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALINIA
See the table below for patents covering ALINIA around the world.
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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