cliffwatch

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.

FDA has approved 4 generic applications (ANDAs) for Calcium Gluconate In Sodium Chloride, though its earliest generic-entry date is 25 Jul 2037 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 2 unexpired

PatentClaimsExpires
US 10130646drug product · sets the listed date25 Jul 2037
US 10342813drug product · sets the listed date25 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 · 210906-001
  • 25 Oct 2026Generic approved · 210906-001
  • 25 Oct 2026Generic approved · 210906-001
  • 25 Oct 2026Generic approved · 210906-001

Products covered · 5

NDA · productFormStrengthListed expiry
208418 · 004 · RLD · discontinuedsolution, intravenous1GM/50ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**25 Jul 2037
208418 · 005 · RLD · discontinuedsolution, intravenous2GM/100ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**25 Jul 2037
210906 · 001 · RLDsolution, intravenous1GM/50ML (20MG/ML)25 Jul 2037
210906 · 002 · RLDsolution, intravenous2GM/100ML (20MG/ML)25 Jul 2037
210906 · 003 · RLDsolution, intravenous1GM/100ML (10MG/ML)25 Jul 2037