HYDREA Drug Patent Profile
Which patents cover Hydrea, and what generic alternatives are available?
Hydrea is a drug marketed by Waylis Therap and is included in one NDA.
The generic ingredient in HYDREA is hydroxyurea. There is one drug master file entry 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 Hydrea
A generic version of HYDREA was approved as hydroxyurea by BARR on October 16th, 1998.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for HYDREA?
- What are the global sales for HYDREA?
- What is Average Wholesale Price for HYDREA?
Summary for HYDREA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 26 |
| Patent Applications: | 4,492 |
| Drug Prices: | Drug price information for HYDREA |
| What excipients (inactive ingredients) are in HYDREA? | HYDREA excipients list |
| DailyMed Link: | HYDREA at DailyMed |
Recent Clinical Trials for HYDREA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 2 |
| Vanderbilt University Medical Center | Phase 2 |
| Aminu Kano Teaching Hospital | Phase 2 |
Pharmacology for HYDREA
| Drug Class | Antimetabolite |
US Patents and Regulatory Information for HYDREA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 HYDREA
| 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 | 3,968,249 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |


