Calcium gluconate - Generic Drug Details
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What are the generic drug sources for calcium gluconate and what is the scope of freedom to operate?
Calcium gluconate
is the generic ingredient in two branded drugs marketed by Amneal, B Braun Medical Inc, Fresenius Kabi Usa, Nivagen Pharms Inc, Somerset, and Hq Spclt Pharma, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for calcium gluconate. Eleven suppliers are listed for this compound.
Summary for calcium gluconate
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 71 |
Clinical Trials: | 30 |
Patent Applications: | 6,585 |
Drug Prices: | Drug price trends for calcium gluconate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for calcium gluconate |
What excipients (inactive ingredients) are in calcium gluconate? | calcium gluconate excipients list |
DailyMed Link: | calcium gluconate at DailyMed |
Recent Clinical Trials for calcium gluconate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ascension Genesys Hospital | Phase 2 |
Aurora Health Care | Phase 4 |
First Affiliated Hospital Xi'an Jiaotong University | N/A |
Pharmacology for calcium gluconate
Drug Class | Blood Coagulation Factor Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
Physiological Effect | Increased Coagulation Factor Activity |
Anatomical Therapeutic Chemical (ATC) Classes for calcium gluconate
US Patents and Regulatory Information for calcium gluconate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 217174-001 | Sep 5, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal | CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 217174-002 | Sep 5, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 208418-003 | Jun 15, 2017 | 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 |
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