norepinephrine bitartrate · Baxter Hlthcare Corp · NDA 214313, 214628, 215700
Norepinephrine Bitartrate In 0.9% Sodium Chloride
Other strengths are listed to 26 Apr 2039; 3 of 10 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 10159657, US 10226436, US 10420735, US 10568850, US 11413259, US 11602508, US 12245996.
FDA has approved 1 generic application (ANDA) for Norepinephrine Bitartrate In 0.9% Sodium Chloride, though its earliest generic-entry date is 30 Jan 2038 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 · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10888534 | drug product | 26 Apr 2039 |
| US 10159657 | drug product · sets the listed date | 30 Jan 2038 |
| US 10226436 | drug product, use U-3461 · sets the listed date | 30 Jan 2038 |
| US 10420735 | drug product, use U-3461 · sets the listed date | 30 Jan 2038 |
| US 10568850 | drug product · sets the listed date | 30 Jan 2038 |
| US 11413259 | drug product, use U-3461 · sets the listed date | 30 Jan 2038 |
| US 11602508 | drug product · sets the listed date | 30 Jan 2038 |
| US 12245996 | drug product · sets the listed date | 30 Jan 2038 |
| US RE49422 | drug product | 26 Feb 2035 |
| US RE49443 | drug product | 26 Feb 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
- 25 Oct 2026Generic approved · 215700-00126 Mar 2026
Products covered · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214313 · 004 · RLD | solution, intravenous | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | open |
| 214313 · 005 · RLD | solution, intravenous | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | open |
| 214313 · 006 · RLD | solution, intravenous | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | open |
| 214628 · 001 · RLD | solution, intravenous | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | 30 Jan 2038 |
| 214628 · 002 · RLD | solution, intravenous | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | 30 Jan 2038 |
| 214628 · 003 · RLD | solution, intravenous | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | 30 Jan 2038 |
| 215700 · 001 · RLD | solution, intravenous | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | 26 Apr 2039 |
| 215700 · 002 · RLD | solution, intravenous | EQ 8MG BASE/250ML (EQ 32MCG BASE/ML) | 26 Apr 2039 |
| 215700 · 003 · RLD | solution, intravenous | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | 26 Apr 2039 |
| 215700 · 004 · RLD | solution, intravenous | EQ 32MG BASE/250ML (EQ 128MCG BASE/ML) | 26 Apr 2039 |