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. Three suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dotarem
A generic version of DOTAREM was approved as gadoterate meglumine by HENGRUI PHARMA on April 11th, 2022.
Summary for DOTAREM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 28 |
| 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 |
|---|---|
| Boehringer Ingelheim | Phase 2 |
| Massachusetts General Hospital | Phase 2 |
| Mazandaran University of Medical Sciences | Phase 2 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-004 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-002 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-003 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-001 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
