Gadoterate meglumine - Generic Drug Details
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What are the generic sources for gadoterate meglumine and what is the scope of freedom to operate?
Gadoterate meglumine
is the generic ingredient in three branded drugs marketed by Ge Healthcare, Guerbet, Hainan Poly, and Hengrui Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.Four suppliers are listed for this compound.
Summary for gadoterate meglumine
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| Clinical Trials: | 15 |
| What excipients (inactive ingredients) are in gadoterate meglumine? | gadoterate meglumine excipients list |
| DailyMed Link: | gadoterate meglumine at DailyMed |
Recent Clinical Trials for gadoterate meglumine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 3 |
| Massachusetts General Hospital | Phase 2 |
| Boehringer Ingelheim | Phase 2 |
Pharmacology for gadoterate meglumine
| Drug Class | Gadolinium-based Contrast Agent |
| Mechanism of Action | Magnetic Resonance Contrast Activity |
US Patents and Regulatory Information for gadoterate meglumine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hengrui Pharma | GADOTERATE MEGLUMINE | gadoterate meglumine | SOLUTION;INTRAVENOUS | 215304-005 | Apr 15, 2022 | AP | RX | No | No | ⤷ 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 | |||
| Hengrui Pharma | GADOTERATE MEGLUMINE | gadoterate meglumine | SOLUTION;INTRAVENOUS | 215304-002 | Apr 11, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ge Healthcare | CLARISCAN | gadoterate meglumine | SOLUTION;INTRAVENOUS | 210016-002 | Nov 1, 2019 | AP | RX | No | No | ⤷ 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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