HYDROXYUREA Drug Patent Profile
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Which patents cover Hydroxyurea, and what generic alternatives are available?
Hydroxyurea is a drug marketed by Barr, Barr Labs Inc, Leading, Par Pharm, Qilu, and Roxane. and is included in seven NDAs.
The generic ingredient in HYDROXYUREA 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 Hydroxyurea
A generic version of HYDROXYUREA was approved as hydroxyurea by BARR on October 16th, 1998.
Summary for HYDROXYUREA
US Patents: | 0 |
Applicants: | 6 |
NDAs: | 7 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 159 |
Clinical Trials: | 283 |
Patent Applications: | 1,706 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HYDROXYUREA |
DailyMed Link: | HYDROXYUREA at DailyMed |
Recent Clinical Trials for HYDROXYUREA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Hospital Los Angeles | Phase 1/Phase 2 |
Novartis | Phase 1/Phase 2 |
Institute of Hematology & Blood Diseases Hospital | Phase 2 |
Pharmacology for HYDROXYUREA
Drug Class | Antimetabolite |
Medical Subject Heading (MeSH) Categories for HYDROXYUREA
US Patents and Regulatory Information for HYDROXYUREA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Barr | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143-002 | Sep 21, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Qilu | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 218021-001 | Mar 6, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Barr Labs Inc | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075020-001 | Jul 30, 1998 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Roxane | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 074476-001 | Aug 18, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Barr | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143-001 | Oct 16, 1998 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Barr Labs Inc | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075020-002 | Jun 26, 2000 | DISCN | No | 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 |