magnesium sulfate; potassium chloride; sodium sulfate · Azurity · NDA 213135

Sutab

Earliest generic entry, as listed
4 Aug 2037

Blocked by patent: US 10143656, US 11033498, US 11382864, US 11638697.

Listed patents · 4 unexpired

PatentClaimsExpires
US 10143656product4 Aug 2037
US 11033498use U-31644 Aug 2037
US 11382864use U-31644 Aug 2037
US 11638697product4 Aug 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 2026First generic approved · 213135-001
  • 25 Oct 2026Generic approved · 213135-001

Products covered · 1

NDA · productFormStrengthListed expiry
213135 · 001 · RLDtablet, oral0.225GM;0.188GM;1.479GM4 Aug 2037