phenylephrine hydrochloride · Dr Reddys Labs Sa · NDA 212909
Biorphen
Earliest generic entry, as listed
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 212909-0013 Apr 2026
- 25 Oct 2026Generic approved · 212909-00124 Sep 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212909 · 001 · RLD | solution, intravenous | 0.5MG/5ML (0.1MG/ML) | open |
| 212909 · 002 · RLD · discontinued | solution, intravenous | 10MG/ML (10MG/ML) | open |