Data updated: Mar 10, 2026
ORIAHNN (COPACKAGED)
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE
Approved 2020-05-29
1
Indication
--
Phase 3 Trials
5
Years on Market
Details
- Status
- Prescription
- First Approved
- 2020-05-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
Website: ↗
ORIAHNN (COPACKAGED) Approval History
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What ORIAHNN (COPACKAGED) Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- 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.
ORIAHNN (COPACKAGED) FDA Label Details
ProORIAHNN (COPACKAGED) Patents & Exclusivity
Latest Patent: Aug 2040
Patents (7 active)
US11690845
Expires Aug 27, 2040
US11542239
Expires Jul 23, 2039
US12083227
Expires Aug 20, 2038
US10881659
Expires Mar 14, 2034
US11045470
Expires Mar 14, 2034
US7419983
Expires Jul 6, 2029
US11459305
Expires Nov 7, 2028
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.