ephedrine sulfate · Ph Health · NDA 208609, 213994
Ephedrine Sulfate
Earliest generic entry, as listed · earliest of 2 marketed strengths
22 Jan 2040
Blocked by patent: US 10869845, US 12029710.
FDA has approved 3 generic applications (ANDAs) for Ephedrine Sulfate, though its earliest generic-entry date is 22 Jan 2040 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
| Patent | Claims | Expires |
|---|---|---|
| US 10869845 | drug product · sets the listed date | 22 Jan 2040 |
| US 12029710 | use U-3963 · sets the listed date | 22 Jan 2040 |
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
- Generic approved · ANDA 219991, Fresenius Kabi Usa · 213994-001Approved 19 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216740, Baxter Hlthcare Corp · 213994-001Approved 8 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 215593, Civica · 213994-001Approved 23 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208609 · 001 · discontinued | solution, intravenous | 50MG/ML (50MG/ML) | open |
| 213994 · 001 · RLD | solution, intravenous | 50MG/10ML (5MG/ML) | 22 Jan 2040 |
| 213994 · 002 · RLD | solution, intravenous | 25MG/5ML (5MG/ML) | 22 Jan 2040 |