HYDROXYUREA - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for hydroxyurea and what is the scope of freedom to operate?
Hydroxyurea
is the generic ingredient in five branded drugs marketed by Cheplapharm, Barr, Barr Labs Inc, Endo Operations, Leading, Qilu, Roxane, Nova Labs Ltd, and Theravia, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are ten drug master file entries for hydroxyurea. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for HYDROXYUREA
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 9 |
NDAs: | 10 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 159 |
Clinical Trials: | 288 |
Patent Applications: | 3,970 |
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 |
---|---|
Italfarmaco | Phase 3 |
Merck Sharp & Dohme LLC | Phase 3 |
Novartis | Phase 1/Phase 2 |
Generic filers with tentative approvals for HYDROXYUREA
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Leading | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 213438-001 | Apr 8, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075340-001 | Feb 24, 1999 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Barr | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143-001 | Oct 16, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.