DOTAREM Drug Patent 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 27 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DOTAREM |
| What excipients (inactive ingredients) are in DOTAREM? | DOTAREM excipients list |
| DailyMed Link: | DOTAREM at DailyMed |
Recent Clinical Trials for DOTAREM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mazandaran University of Medical Sciences | Phase 2 |
| Bayer AG (Sponsor) | Phase 4 |
| GEHC (Sponsor) | Phase 4 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-004 | Mar 20, 2013 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-002 | Mar 20, 2013 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
