Edetate calcium disodium - Generic Drug Details
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What are the generic drug sources for edetate calcium disodium and what is the scope of freedom to operate?
Edetate calcium disodium
is the generic ingredient in two branded drugs marketed by Bausch and Casper Pharma Llc, 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 edetate calcium disodium. Two suppliers are listed for this compound.
Summary for edetate calcium disodium
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 156 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,555 |
| What excipients (inactive ingredients) are in edetate calcium disodium? | edetate calcium disodium excipients list |
| DailyMed Link: | edetate calcium disodium at DailyMed |
Recent Clinical Trials for edetate calcium disodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| M.D. Anderson Cancer Center | Phase 1 |
| Mt. Sinai Medical Center, Miami | Phase 4 |
Pharmacology for edetate calcium disodium
| Drug Class | Anti-coagulant Lead Chelator |
| Mechanism of Action | Calcium Chelating Activity Lead Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
US Patents and Regulatory Information for edetate calcium disodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch | CALCIUM DISODIUM VERSENATE | edetate calcium disodium | INJECTABLE;INJECTION | 008922-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch | CALCIUM DISODIUM VERSENATE | edetate calcium disodium | TABLET;ORAL | 008922-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Casper Pharma Llc | EDETATE CALCIUM DISODIUM | edetate calcium disodium | INJECTABLE;INJECTION | 216435-001 | May 3, 2023 | RX | No | 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 |
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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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