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epinephrine · Ph Health · NDA 204200, 204640, 215875

Adrenalin

Earliest generic entry, as listed · earliest of 7 marketed strengths
13 Mar 2035

Other strengths are listed to 21 Mar 2039.

Blocked by patent: US 10130592, US 12280024, US 9119876, US 9295657.

Listed patents · 8 unexpired

PatentClaimsExpires
US 10653646product21 Mar 2039
US 11083698use U-356721 Mar 2039
US 11207280product21 Mar 2039
US 12133837product21 Mar 2039
US 10130592product13 Mar 2035
US 12280024product13 Mar 2035
US 9119876product13 Mar 2035
US 9295657use U-182913 Mar 2035

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

  • 26 Oct 2026Generic approved · 204200-001
  • 26 Oct 2026Generic approved · 204200-001
  • 25 Oct 2026Generic approved · 204640-001
  • 25 Oct 2026Generic approved · 204640-001
  • 25 Oct 2026Generic approved · 204640-001
  • 25 Oct 2026Generic approved · 204640-001
  • 25 Oct 2026Generic approved · 204640-001
  • 25 Oct 2026Generic approved · 204640-001

Products covered · 7

NDA · productFormStrengthListed expiry
204200 · 001 · RLDsolution, intramuscular, intravenous, subcutaneousEQ 1MG BASE/ML (EQ 1MG BASE/ML)13 Mar 2035
204640 · 001 · RLDsolution, intramuscular, intravenous, subcutaneousEQ 30MG BASE/30ML (EQ 1MG BASE/ML)13 Mar 2035
215875 · 001 · RLDsolution, intravenous2MG/250ML (8MCG/ML)21 Mar 2039
215875 · 002 · RLDsolution, intravenous4MG/250ML (16MCG/ML)21 Mar 2039
215875 · 003 · RLDsolution, intravenous5MG/250ML (20MCG/ML)21 Mar 2039
215875 · 004 · RLDsolution, intravenous8MG/250ML (32MCG/ML)21 Mar 2039
215875 · 005 · RLDsolution, intravenous10MG/250ML (40MCG/ML)21 Mar 2039