ALINIA Drug Patent Profile
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When do Alinia patents expire, 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. Three suppliers are 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.
Summary for ALINIA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 18 |
Patent Applications: | 3,153 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Virginia | Phase 2/Phase 3 |
Bill and Melinda Gates Foundation | Phase 2/Phase 3 |
Haydom Lutheran Hospital | Phase 2/Phase 3 |
Pharmacology for ALINIA
Drug Class | Antiprotozoal |
Anatomical Therapeutic Chemical (ATC) Classes for ALINIA
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 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Romark | ALINIA | nitazoxanide | TABLET;ORAL | 021497-001 | Jul 21, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Romark | ALINIA | nitazoxanide | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Romark | ALINIA | nitazoxanide | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Czech Republic | 298269 | Orální farmaceutický prípravek (Pharmaceutical composition of tizoxanide and/or nitazoxanide) | ⤷ Try a Trial |
Bulgaria | 62932 | ⤷ Try a Trial | |
Australia | 756451 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |