propranolol hydrochloride · Eton · NDA 205410
Hemangeol
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.
FDA has approved 1 generic application (ANDA) for Hemangeol, though its earliest generic-entry date is 16 Oct 2028 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 · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8338489 | use U-1496 · sets the listed date | 16 Oct 2028 |
| US 8987262 | use U-1988 · sets the listed date | 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
- Generic approved · ANDA 219165, Pai Holdings · 205410-001Approved 10 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205410 · 001 · RLD | solution, oral | 4.28MG/ML | 16 Oct 2028 |