HYDROXYUREA - Generic Drug Details
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What are the generic drug sources for hydroxyurea and what is the scope of freedom to operate?
Hydroxyurea
is the generic ingredient in four branded drugs marketed by Cheplapharm, Barr, Barr Labs Inc, Leading, Par Pharm, Qilu, Roxane, and Theravia, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for hydroxyurea. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for HYDROXYUREA
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 8 |
NDAs: | 9 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 159 |
Clinical Trials: | 283 |
Patent Applications: | 3,970 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for HYDROXYUREA |
What excipients (inactive ingredients) are in HYDROXYUREA? | HYDROXYUREA excipients list |
DailyMed Link: | HYDROXYUREA at DailyMed |
Recent Clinical Trials for HYDROXYUREA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Novartis | Phase 1/Phase 2 |
Children's Hospital Los Angeles | Phase 1/Phase 2 |
Institute of Hematology & Blood Diseases Hospital | Phase 2 |
Generic filers with tentative approvals for HYDROXYUREA
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 100MG/ML | SOLUTION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 Labs Inc | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075020-002 | Jun 26, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Barr | HYDROXYUREA | hydroxyurea | TABLET;ORAL | 075734-001 | Aug 29, 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 | |||
Roxane | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 074476-001 | Aug 18, 1995 | 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 |
Expired US Patents for HYDROXYUREA
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 |
Make Better Decisions: Try a trial or see plans & pricing
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