CALCIUM GLUCONATE Drug Patent Profile
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Which patents cover Calcium Gluconate, and when can generic versions of Calcium Gluconate launch?
Calcium Gluconate is a drug marketed by B Braun Medical Inc, Fresenius Kabi Usa, Nivagen Pharms Inc, Somerset, Amneal, and Hq Spclt Pharma. and is included in six NDAs. There are two patents protecting this drug.
The generic ingredient in CALCIUM GLUCONATE is calcium gluconate. There are two hundred and eighty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the calcium gluconate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Calcium Gluconate
A generic version of CALCIUM GLUCONATE was approved as calcium gluconate by FRESENIUS KABI USA on June 15th, 2017.
Summary for CALCIUM GLUCONATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 30 |
| Patent Applications: | 4,243 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
CALCIUM GLUCONATE is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting CALCIUM GLUCONATE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Try a Trial
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Braun Medical Inc | CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 216541-001 | Aug 21, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hq Spclt Pharma | CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 210906-002 | Oct 29, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Somerset | CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 217689-001 | Oct 19, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 208418-003 | Jun 15, 2017 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Fresenius Kabi Usa | CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 208418-005 | Jun 17, 2021 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Somerset | CALCIUM GLUCONATE | calcium gluconate | SOLUTION;INTRAVENOUS | 217689-002 | Oct 19, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hq Spclt Pharma | CALCIUM GLUCONATE IN SODIUM CHLORIDE | calcium gluconate | SOLUTION;INTRAVENOUS | 210906-003 | Jun 4, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
