Urea - Generic Drug Details
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What are the generic drug sources for urea and what is the scope of freedom to operate?
Urea
is the generic ingredient in eight branded drugs marketed by Hospira, Otsuka America, Metabolic Solutions, Dxs Devices, and Avent, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-three drug master file entries for urea.
Summary for urea
| US Patents: | 0 |
| Tradenames: | 8 |
| Applicants: | 5 |
| NDAs: | 6 |
| Drug Master File Entries: | 33 |
| Raw Ingredient (Bulk) Api Vendors: | 216 |
| Patent Applications: | 6,220 |
| Drug Prices: | Drug price trends for urea |
| DailyMed Link: | urea at DailyMed |
US Patents and Regulatory Information for urea
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dxs Devices | PYLORI-CHEK BREATH TEST | urea c-13 | FOR SOLUTION;ORAL | 020900-001 | Feb 4, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | UREAPHIL | urea | INJECTABLE;INJECTION | 012154-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Otsuka America | BREATHTEK UBT FOR H-PYLORI | urea c-13 | FOR SOLUTION;ORAL | 020586-002 | May 10, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Avent | PYTEST KIT | urea, c-14 | CAPSULE;ORAL | 020617-002 | May 9, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | STERILE UREA | urea | INJECTABLE;INJECTION | 017698-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
