Data updated: Mar 29, 2026
ZOHYDRO ER
HYDROCODONE BITARTRATE
Approved 2013-10-25
1
Indication
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-10-25
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
ZOHYDRO ER Approval History
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What ZOHYDRO ER Treats
1 FDA approvalsOriginally approved for its first indication in 2013 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZOHYDRO ER FDA Label Details
ProZOHYDRO ER Patents & Exclusivity
Latest Patent: Sep 2034
Patents (576 active)
US9486451
Expires Sep 12, 2034
US9713611
Expires Sep 12, 2034
US10092559
Expires Sep 12, 2034
US9452163
Expires Sep 12, 2034
US9132096
Expires Sep 12, 2034
US9326982
Expires Jul 25, 2033
US9265760
Expires Jul 25, 2033
US9421200
Expires Jul 25, 2033
US9433619
Expires Jul 25, 2033
US9339499
Expires Jul 25, 2033
+ 566 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.