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DOTAREM Drug Profile
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Which patents cover Dotarem, and what generic alternatives are available?
Dotarem is a drug marketed by Guerbet and is included in one NDA.
The generic ingredient in DOTAREM is gadoterate meglumine. Two suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for DOTAREM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 26 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DOTAREM |
| DailyMed Link: | DOTAREM at DailyMed |
Recent Clinical Trials for DOTAREM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Chicago | Early Phase 1 |
| Guerbet | Early Phase 1 |
| GEHC (Sponsor) | Phase 4 |
Pharmacology for DOTAREM
| Drug Class | Gadolinium-based Contrast Agent |
| Mechanism of Action | Magnetic Resonance Contrast Activity |
US Patents and Regulatory Information for DOTAREM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-005 | Mar 31, 2017 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-004 | Mar 20, 2013 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-002 | Mar 20, 2013 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-003 | Mar 20, 2013 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-001 | Mar 20, 2013 | AP | 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 |
