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. 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.
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Questions you can ask:
- What is the 5 year forecast for ALINIA?
- What are the global sales for ALINIA?
- What is Average Wholesale Price for ALINIA?
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 |
![ALINIA drug patent expirations Drug patent expirations by year for ALINIA](/p/graph/s/t/ALINIA-patent-expirations.png)
![Drug Prices for ALINIA](/p/graph/drug-price/ALINIA.png)
Recent Clinical Trials for ALINIA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Haydom Lutheran Hospital | Phase 2/Phase 3 |
University of Virginia | Phase 2/Phase 3 |
Bill and Melinda Gates Foundation | 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 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Romark | ALINIA | nitazoxanide | TABLET;ORAL | 021497-001 | Jul 21, 2004 | AB | RX | Yes | Yes | ⤷ 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 | FOR SUSPENSION;ORAL | 021498-001 | Nov 22, 2002 | ⤷ Sign Up | ⤷ Sign Up |
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 | 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 |
>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 |
---|---|---|---|
Slovakia | 283947 | ⤷ Sign Up | |
Serbia | 20070379 | ⤷ Sign Up | |
Australia | 689582 | ⤷ Sign Up | |
Slovenia | 20149 | PHARMACEUTICAL COMPOSITIONS OF TIZOXANIDE AND NITAZOXANIDE | ⤷ Sign Up |
South Korea | 100426657 | ⤷ Sign Up | |
New Zealand | 284800 | 2-HYDROXY-N-(5-NITRO-THIAZOL-2-YL)-BENZAMIDE, MEDICAMENTS PARTICULARLY IN CONJUNCTION WITH THE ACETYLATED FORM | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |