hydrocodone bitartrate · Recro Gainesville · NDA 202880
Zohydro Er
Earliest generic entry, as listed · earliest of 6 marketed strengths
12 Sep 2034
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10092559, US 9132096, US 9452163, US 9486451, US 9713611.
Listed patents · 16 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10092559 | use U-55 | 12 Sep 2034 |
| US 9132096 | product | 12 Sep 2034 |
| US 9452163 | use U-55 | 12 Sep 2034 |
| US 9486451 | use U-55 | 12 Sep 2034 |
| US 9713611 | product, use U-55 | 12 Sep 2034 |
| US 10028946 | use U-1810 | 25 Jul 2033 |
| US 10322120 | product | 25 Jul 2033 |
| US 10456393 | use U-1810 | 25 Jul 2033 |
| US 10722511 | use U-1810 | 25 Jul 2033 |
| US 9265760 | use U-1810 | 25 Jul 2033 |
| US 9326982 | use U-1810 | 25 Jul 2033 |
| US 9333201 | use U-1810 | 25 Jul 2033 |
| US 9339499 | use U-1810 | 25 Jul 2033 |
| US 9421200 | use U-1810 | 25 Jul 2033 |
| US 9433619 | use U-1810 | 25 Jul 2033 |
| US 9610286 | use U-1810 | 25 Jul 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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202880 · 001 · RLD · discontinued | capsule, extended release, oral | 10MG | 12 Sep 2034 |
| 202880 · 002 · RLD · discontinued | capsule, extended release, oral | 15MG | 12 Sep 2034 |
| 202880 · 003 · RLD · discontinued | capsule, extended release, oral | 20MG | 12 Sep 2034 |
| 202880 · 004 · RLD · discontinued | capsule, extended release, oral | 30MG | 12 Sep 2034 |
| 202880 · 005 · RLD · discontinued | capsule, extended release, oral | 40MG | 12 Sep 2034 |
| 202880 · 006 · RLD · discontinued | capsule, extended release, oral | 50MG | 12 Sep 2034 |