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DOTAREM Drug Profile
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When do Dotarem patents expire, and when can generic versions of Dotarem launch?
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: | 24 |
| 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 |
|---|---|
| Boston Medical Center | Phase 4 |
| Massachusetts General Hospital | Phase 4 |
| Guerbet | N/A |
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 | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
