phenylephrine hydrochloride · Paragon Bioteck · NDA 203510, 203826, 207926
Phenylephrine Hydrochloride
Earliest generic entry, as listed · earliest of 7 marketed strengths
14 Nov 2033
5 of 7 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 8859623. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8859623 | use U-1594 | 14 Nov 2033 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203510 · 001 · RLD | solution/drops, ophthalmic | 2.5% | 14 Nov 2033 |
| 203510 · 002 · RLD | solution/drops, ophthalmic | 10% | 14 Nov 2033 |
| 203826 · 001 · RLD | solution, intravenous | 10MG/ML (10MG/ML) | open |
| 203826 · 002 · RLD | solution, intravenous | 50MG/5ML (10MG/ML) | open |
| 203826 · 003 · RLD | solution, intravenous | 100MG/10ML (10MG/ML) | open |
| 207926 · 001 · RLD | solution/drops, ophthalmic | 2.5% | open |
| 207926 · 002 · RLD | solution/drops, ophthalmic | 10% | open |