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. Four 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.
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Questions you can ask:
- What is the 5 year forecast for DOTAREM?
- What are the global sales for DOTAREM?
- What is Average Wholesale Price for DOTAREM?
Summary for DOTAREM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 30 |
| Patent Applications: | 1 |
| 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 |
|---|---|
| Johns Hopkins University | Phase 4 |
| Massachusetts General Hospital | Phase 2 |
| Boehringer Ingelheim | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-004 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-002 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-003 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Guerbet | DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781-001 | Mar 20, 2013 | AP | RX | Yes | Yes | ⤷ 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 |
