HYDREA Drug Patent Profile
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Which patents cover Hydrea, and what generic alternatives are available?
Hydrea is a drug marketed by Cheplapharm and is included in one NDA.
The generic ingredient in HYDREA 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 Hydrea
A generic version of HYDREA was approved as hydroxyurea by BARR on October 16th, 1998.
Summary for HYDREA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 159 |
Clinical Trials: | 26 |
Patent Applications: | 1,706 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HYDREA |
What excipients (inactive ingredients) are in HYDREA? | HYDREA excipients list |
DailyMed Link: | HYDREA at DailyMed |
Recent Clinical Trials for HYDREA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mayo Clinic | Phase 2 |
Murtala Muhammad Specialist Hospital | Phase 2 |
Vanderbilt University Medical Center | Phase 2 |
Pharmacology for HYDREA
Drug Class | Antimetabolite |
US Patents and Regulatory Information for HYDREA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cheplapharm | HYDREA | hydroxyurea | CAPSULE;ORAL | 016295-001 | Approved Prior to Jan 1, 1982 | 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 HYDREA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | HYDREA | hydroxyurea | CAPSULE;ORAL | 016295-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |