calcium gluconate · Hq Spclt Pharma · NDA 208418, 210906
Calcium Gluconate In Sodium Chloride
Earliest generic entry, as listed · earliest of 3 marketed strengths
25 Jul 2037
Blocked by patent: US 10130646, US 10342813.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10130646 | product | 25 Jul 2037 |
| US 10342813 | product | 25 Jul 2037 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 210906-00128 Aug 2026
- 25 Oct 2026Generic approved · 210906-0014 May 2026
- 25 Oct 2026Generic approved · 210906-00117 Sep 2026
- 25 Oct 2026Generic approved · 210906-00130 Dec 2025
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208418 · 004 · RLD · discontinued | solution, intravenous | 1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 25 Jul 2037 |
| 208418 · 005 · RLD · discontinued | solution, intravenous | 2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 25 Jul 2037 |
| 210906 · 001 · RLD | solution, intravenous | 1GM/50ML (20MG/ML) | 25 Jul 2037 |
| 210906 · 002 · RLD | solution, intravenous | 2GM/100ML (20MG/ML) | 25 Jul 2037 |
| 210906 · 003 · RLD | solution, intravenous | 1GM/100ML (10MG/ML) | 25 Jul 2037 |