phenylephrine hydrochloride · Dr Reddys Labs Sa · NDA 216830
Phenylephrine Hydrochloride In 0.9% Sodium Chloride
Blocked by patent: US 12564561.
FDA has approved 1 generic application (ANDA) for Phenylephrine Hydrochloride In 0.9% Sodium Chloride, though its earliest generic-entry date is 8 Aug 2044 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 · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12564561 | drug product · sets the listed date | 8 Aug 2044 |
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 215268, Nephron · 216830-001Approved 24 Sep 2026Detected 25 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216830 · 001 · RLD | solution, intravenous | 20MG/250ML (0.08MG/ML) | 8 Aug 2044 |