DROXIA Drug Patent Profile
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Which patents cover Droxia, and what generic alternatives are available?
Droxia is a drug marketed by Cheplapharm and is included in one NDA.
The generic ingredient in DROXIA is hydroxyurea. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Droxia
A generic version of DROXIA was approved as hydroxyurea by BARR on October 16th, 1998.
Summary for DROXIA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 159 |
Clinical Trials: | 13 |
Patent Applications: | 1,706 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DROXIA |
What excipients (inactive ingredients) are in DROXIA? | DROXIA excipients list |
DailyMed Link: | DROXIA at DailyMed |
Recent Clinical Trials for DROXIA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Phase 1 |
Mayo Clinic | Phase 2 |
St. Jude Children's Research Hospital | Phase 2 |
Pharmacology for DROXIA
Drug Class | Antimetabolite |
US Patents and Regulatory Information for DROXIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cheplapharm | DROXIA | hydroxyurea | CAPSULE;ORAL | 016295-002 | Feb 25, 1998 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cheplapharm | DROXIA | hydroxyurea | CAPSULE;ORAL | 016295-003 | Feb 25, 1998 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cheplapharm | DROXIA | hydroxyurea | CAPSULE;ORAL | 016295-004 | Feb 25, 1998 | RX | Yes | No | ⤷ 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 |