UREA C-13 - Generic Drug Details
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What are the generic sources for urea c-13 and what is the scope of freedom to operate?
Urea c-13
is the generic ingredient in four branded drugs marketed by Otsuka America, Metabolic Solutions, and Dxs Devices, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.Summary for UREA C-13
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 3 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Patent Applications: | 197 |
| What excipients (inactive ingredients) are in UREA C-13? | UREA C-13 excipients list |
| DailyMed Link: | UREA C-13 at DailyMed |
US Patents and Regulatory Information for UREA C-13
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Metabolic Solutions | HELICOSOL | urea c-13 | FOR SOLUTION;ORAL | 021092-001 | Dec 17, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Otsuka America | MERETEK UBT KIT (W/ PRANACTIN) | urea c-13 | FOR SOLUTION;ORAL | 020586-001 | Sep 17, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | ||||
| 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 | ||||
| >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 UREA C-13
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka America | BREATHTEK UBT FOR H-PYLORI | urea c-13 | FOR SOLUTION;ORAL | 020586-002 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka America | MERETEK UBT KIT (W/ PRANACTIN) | urea c-13 | FOR SOLUTION;ORAL | 020586-001 | Sep 17, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka America | MERETEK UBT KIT (W/ PRANACTIN) | urea c-13 | FOR SOLUTION;ORAL | 020586-001 | Sep 17, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka America | BREATHTEK UBT FOR H-PYLORI | urea c-13 | FOR SOLUTION;ORAL | 020586-002 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
