What this means
CALCIUM GLUCONATE is the active ingredient in CALCIUM GLUCONATE / CALCIUM GLUCONATE IN SODIUM CHLORIDE (marketed by FRESENIUS KABI USA LLC and 1 others). Available as solution;intravenous. First approved 2017 — 9 years on market. Currently protected by 2 patents. The earliest market opportunity is 2037-07-24 (11 years out). This drug has FDA Competitive Generic Therapy designation — first-to-file generic earns 180-day exclusivity, FDA expedites approval. 16+ ANDAs already filed — saturated market, thin margins expected. Bottom line: saturated — high competition will compress margins.
Designated 2022-10-14. First CGT approval: Nivagen Pharmaceuticals, Inc, ANDA 213071, approved 2022-10-14
| Patent | Type | Expiry | Verdict |
|---|---|---|---|
| US 10130646 ↗US 10130646 | Product | 2037-07-24 | — |
| US 10342813 ↗US 10342813 | Product | 2037-07-24 | — |
1GM/10ML (100MG/ML) · SOLUTION;INTRAVENOUS · approved 2017-06-14 · FRESENIUS KABI USA LLC
5GM/50ML (100MG/ML) · SOLUTION;INTRAVENOUS · approved 2017-06-14 · FRESENIUS KABI USA LLC
10GM/100ML (100MG/ML) · SOLUTION;INTRAVENOUS · approved 2017-06-14 · FRESENIUS KABI USA LLC
1GM/50ML (20MG/ML) · SOLUTION;INTRAVENOUS · approved 2021-06-16 · FRESENIUS KABI USA LLC
2GM/100ML (20MG/ML) · SOLUTION;INTRAVENOUS · approved 2021-06-16 · FRESENIUS KABI USA LLC
1GM/50ML (20MG/ML) · SOLUTION;INTRAVENOUS · approved 2018-10-28 · HQ SPECIALTY PHARMA CORP
1GM/100ML (10MG/ML) · SOLUTION;INTRAVENOUS · approved 2021-06-03 · HQ SPECIALTY PHARMA CORP
2GM/100ML (20MG/ML) · SOLUTION;INTRAVENOUS · approved 2018-10-28 · HQ SPECIALTY PHARMA CORP
1GM/10ML (100MG/ML) · approved 2024-05-09
5GM/50ML (100MG/ML) · approved 2024-05-09
10GM/100ML (100MG/ML) · approved 2024-05-09
10GM/100ML (100MG/ML) · approved 2023-08-20
1GM/10ML (100MG/ML) · approved 2026-05-03
5GM/50ML (100MG/ML) · approved 2026-05-03
10GM/100ML (100MG/ML) · approved 2026-05-03
1GM/10ML (100MG/ML) · approved 2022-10-13
5GM/50ML (100MG/ML) · approved 2023-10-18
10GM/100ML (100MG/ML) · approved 2024-04-29