Data updated: May 26, 2026
EMBEDA (morphine sulfate)
Pain
Approved 2009-08-13
2
Indications
--
Phase 3 Trials
1
Priority Reviews
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-08-13
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
EMBEDA Approval History
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
114 FDA actions from 2009 to 2019 · 1 indication expansions
Nov 2015 SUPPL Priority
Mfg
Jan 2014 SUPPL Priority
Mfg
Jan 2013 SUPPL Priority
Mfg
What EMBEDA Treats
2 FDA approvalsOriginally approved for its first indication in 2009 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04429516 PAciFy Cough results posted | RBH2019/001 2019-003571-19 | Ph 3 | completed | Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough |
| NCT05324358 | NTM-001-CT001 | Ph 3 | suspended | Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy |
| NCT04772222 DICE results posted | 136561 | Ph 2 | completed | Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) |
| NCT05351229 | IRB22-0561 | Ph 4 | recruiting | Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery |
| NCT04110665 Shoulder1 | Local/2017/PC-03 2017-A01316-47 | Ph 4 | completed | Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery |
| NCT05069012 results posted | 2021P000688 | Ph 4 | completed | Intrathecal Morphine for Cesarean Delivery |
| NCT07054775 | HE631484 | Ph 4 | recruiting | Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section |
| NCT03092011 | 16-144 | Ph 4 | active not recruiting | Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy |
| NCT06160778 KETOAPP | 23-0952 | Ph 3 | recruiting | Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain |
| NCT05630222 | 3401308 | Ph 3 | completed | Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen |
| NCT05251376 | LYN-014-C-101 4UH3DA050310-02 | Ph 1 | withdrawn | Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy |
| NCT03088826 results posted | 2017-01-05 | Ph 2 | completed | Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) |
| NCT04688814 | 0304884 | Ph 3 | completed | SEQ Block for Perioperative Analgesia in Acetabular Surgery |
| NCT03483870 | Granisetron in C.S | Ph 2 | completed | Effect of Granisetron on Morphine Induced Pruritus in Cesarean Section |
| NCT04301336 | Novel TTT of pedia VOC/SCA | Ph 2, Ph 3 | completed | Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia |
| NCT03809182 results posted | Dexmedetomidine and glycemia. | Ph 4 | completed | Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. |
| NCT02720822 BEAMS | 030/15 | Ph 3 | completed | Breathlessness Exertion and Morphine Sulphate |
| NCT03429400 | MORP-OS+T-(2-17)-SPK-2 | Ph 3 | completed | Study of Oral Morphine Sulfate Administration in Pediatric Subjects |
| NCT02869321 ANTALGIP | 2014-003352-32 | Ph 4 | completed | Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy |
| NCT01708707 | Banner IRB 01-13-0030 | Ph 2 | completed | Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS) |
| NCT01322360 results posted | MORP-OS+T-(2-17)-SPK-1 | Ph 4 | completed | Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects |
| NCT01871285 results posted | EN3409-204 | Ph 2 | completed | Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film |
| NCT02455362 | 022/13 V.3.2.3 | Ph 3 | withdrawn | Opioids for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease |
| NCT01507220 IMPROVE-Open results posted | MA402S23B301 | Ph 4 | terminated | A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 |
| NCT00901628 results posted | B-0804/056-021 | Ph 4 | completed | Periarticular Multimodal Drug Injections in Total Knee Arthroplasty |
| NCT01016808 | Q8003-008 | Ph 3 | completed | Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients |
| NCT00831051 | Q8003-021 | Ph 2 | completed | Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients |
| NCT01280331 | Q8003-022 | Ph 3 | completed | Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients |
| NCT00678145 results posted | 2012-665 R01DK079974 | Ph 2 | terminated | Mechanisms of Hypoglycemia Associated Autonomic Failure |
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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.
EMBEDA FDA Label Details
View full patent landscape →
7 OB patents · 3 families ·
116 international docs across 24 countries
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Revenue Insights
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Patent Timeline
- • Cliff: 2029
- • 252 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.