fentanyl hydrochloride · The Medicines Co · NDA 021338
Ionsys
Earliest generic entry, as listed
3 Feb 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9095706.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9095706 | drug product · sets the listed date | 3 Feb 2033 |
| US 8428709 | drug product, use U-736 | 11 Jun 2032 |
| US 8428708 | use U-736 | 21 May 2032 |
| US 8781571 | drug product, use U-736 | 31 Mar 2032 |
| US 9731121 | drug product | 17 Oct 2031 |
| US 8301238 | drug product | 30 Sep 2031 |
| US 9364656 | use U-736 | 30 Sep 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021338 · 001 · RLD · discontinued | system, iontophoresis, transdermal | EQ 40MCG BASE/ACTIVATION | 3 Feb 2033 |