Gadopentetate dimeglumine - Generic Drug Details
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What are the generic sources for gadopentetate dimeglumine and what is the scope of freedom to operate?
Gadopentetate dimeglumine
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for gadopentetate dimeglumine.
Summary for gadopentetate dimeglumine
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 16 |
What excipients (inactive ingredients) are in gadopentetate dimeglumine? | gadopentetate dimeglumine excipients list |
DailyMed Link: | gadopentetate dimeglumine at DailyMed |
Recent Clinical Trials for gadopentetate dimeglumine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assiut University | Phase 1/Phase 2 |
Emory University | N/A |
M.D. Anderson Cancer Center | N/A |
US Patents and Regulatory Information for gadopentetate dimeglumine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 019596-001 | Jun 2, 1988 | DISCN | Yes | 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 |
Expired US Patents for gadopentetate dimeglumine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 019596-001 | Jun 2, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 019596-001 | Jun 2, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 019596-001 | Jun 2, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | MAGNEVIST | gadopentetate dimeglumine | INJECTABLE;INJECTION | 021037-001 | Mar 10, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |