propranolol hydrochloride · Eton · NDA 205410
Hemangeol
Earliest generic entry, as listed
16 Oct 2028
Blocked by patent: US 8338489, US 8987262. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8338489 | use U-1496 | 16 Oct 2028 |
| US 8987262 | use U-1988 | 16 Oct 2028 |
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 · 205410-00110 Jun 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205410 · 001 · RLD | solution, oral | 4.28MG/ML | 16 Oct 2028 |