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, Endo Operations, Leading, 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. Sixteen 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.
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Questions you can ask:
- What is the 5 year forecast for HYDROXYUREA?
- What are the global sales for HYDROXYUREA?
- What is Average Wholesale Price for HYDROXYUREA?
Summary for HYDROXYUREA
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 159 |
| Clinical Trials: | 288 |
| Patent Applications: | 1,706 |
| 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 |
|---|---|
| Italfarmaco | Phase 3 |
| Merck Sharp & Dohme LLC | Phase 3 |
| Novartis | Phase 1/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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Qilu | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 218021-001 | Mar 6, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Barr Labs Inc | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075020-001 | Jul 30, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Roxane | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 074476-001 | Aug 18, 1995 | DISCN | 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 | |||
| Barr Labs Inc | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075020-002 | Jun 26, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leading | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 213438-001 | Apr 8, 2020 | 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 |
