hydroxyurea - Profile
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What are the generic sources for hydroxyurea and what is the scope of freedom to operate?
Hydroxyurea
is the generic ingredient in five branded drugs marketed by Waylis Therap, Barr, Barr Labs Inc, Leading, Ph Health, Qilu, Roxane, Nova Labs Ltd, and Theravia, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There is one tentative approval for this compound.
Summary for hydroxyurea
| International Patents: | 9 |
| US Patents: | 1 |
| Tradenames: | 5 |
| Applicants: | 9 |
| NDAs: | 10 |
Generic filers with tentative approvals for HYDROXYUREA
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 1GM | TABLET;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 100MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Waylis Therap | DROXIA | hydroxyurea | CAPSULE;ORAL | 016295-002 | Feb 25, 1998 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Waylis Therap | DROXIA | hydroxyurea | CAPSULE;ORAL | 016295-003 | Feb 25, 1998 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Waylis Therap | DROXIA | hydroxyurea | CAPSULE;ORAL | 016295-004 | Feb 25, 1998 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Waylis Therap | HYDREA | hydroxyurea | CAPSULE;ORAL | 016295-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 |
|---|---|---|---|---|---|---|---|
| Waylis Therap | HYDREA | hydroxyurea | CAPSULE;ORAL | 016295-001 | Approved Prior to Jan 1, 1982 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for hydroxyurea
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2019269123 | A stable aqueous hydroxycarbamide solution | ⤷ Start Trial |
| European Patent Office | 3644967 | SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION) | ⤷ Start Trial |
| European Patent Office | 4434580 | SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION) | ⤷ Start Trial |
| Spain | 2992016 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
