MORPHINE SULFATE
Morphine sulfate tablets are indicated for the management of: adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1984-09-18
- Patent Cliff
- 2034
- Routes
- ORAL, INJECTION, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- TABLET, EXTENDED RELEASE, SOLUTION, INJECTABLE, TABLET, CAPSULE, EXTENDED RELEASE
Companies
MORPHINE SULFATE Approval History
What MORPHINE SULFATE Treats
55 FDA approvalsOriginally approved for its first indication in 1988 . Covers 55 distinct patient populations.
- Other (55)
Other
(55 approvals)- • Approved indication (May 1988)
- • Approved indication (Sep 1991)
- • Approved indication (Sep 1992)
- • Approved indication (Oct 1992)
- • Approved indication (Jul 1996)
- • Approved indication (Jul 1998)Label Letter
- • Approved indication (Jul 1998)Label Letter
- • Approved indication (Oct 1998)Letter
- • Approved indication (Jan 2000)Letter
- • Approved indication (Jan 2001)Letter
- • Approved indication (Jul 2003)
- • Approved indication (Jul 2003)
- • Approved indication (May 2004)
- • Approved indication (Sep 2007)
- • Approved indication (Mar 2008)Label Letter
- • Approved indication (Jan 2010) PriorityLabel Letter
- • Approved indication (Jun 2011)Label Letter
- • Approved indication (Jul 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Nov 2011)Label Letter
- • Approved indication (Jan 2012)
- • Approved indication (May 2012)
- • Approved indication (Aug 2012)
- • Approved indication (Jan 2013)
- • Approved indication (Jun 2013)
- • Approved indication (Oct 2013)Label Letter
- • Approved indication (Feb 2014)
- • Approved indication (Dec 2014)Letter
- • Approved indication (Apr 2015)Label Letter
- • Approved indication (May 2015)Letter
- • Approved indication (May 2015)Letter
- • Approved indication (Oct 2015)Letter
- • Approved indication (Nov 2015)Label Letter
- • Approved indication (Dec 2015)Letter
- • Approved indication (Apr 2016)
- • Approved indication (May 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Jul 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Jun 2017)Letter
- • Approved indication (Jul 2017)
- • Approved indication (Apr 2018)Letter
- • Approved indication (Jul 2019)Letter
- • Approved indication (Dec 2020)Letter
- • Approved indication (Feb 2021)
- • Approved indication (Apr 2021)
- • Approved indication (Jun 2021)Label Letter
- • Approved indication (Aug 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Feb 2022)
- • Approved indication (Jan 2023)Letter
- • Approved indication (Aug 2023)
MORPHINE SULFATE Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of morphine sulfate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of morphine sulfate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate tablets are essential [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of morphine sulfate tablets, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions ( 5.2 )] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of morphine sulfate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions ( 5.4 )]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant
Clinical Trial Registry
246 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 |
| NCT07551739 | HSK55718-202 | Ph 2 | not yet recruiting | A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Orthopedic Surgery |
| NCT07525986 | 2025R0444-0003 | Ph 4 | recruiting | Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery |
| NCT01681264 | 2013P-001510 1R01DA036564-01 | Ph 4 | terminated | Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance |
| NCT05324358 | NTM-001-CT001 | Ph 3 | suspended | Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy |
| NCT03823534 | 28927 | Ph 3 | recruiting | Post-Op Pain Control for Prophylactic Intramedullary Nailing. |
| NCT07533786 | HSK55718-201 | Ph 2 | recruiting | A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery |
| NCT07246785 | 2025R0444 | Ph 4 | terminated | Anrikefon-based Patient-controlled Intravenous Analgesia After Laparoscopic Surgery |
| NCT07076641 LIDORACHI | 2025-521206-18-00 | Ph 3 | not yet recruiting | Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia |
| NCT06464146 ANTAMIN | APHP211044 2023-506803-25 | Ph 3 | recruiting | Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine |
| NCT07491146 | HSK55718-201 | Ph 2 | not yet recruiting | Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain |
| NCT06784180 | 23-3302 | Ph 4 | withdrawn | Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine |
| NCT04772222 DICE results posted | 136561 | Ph 2 | completed | Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) |
| NCT07445737 MAMI | APHP180610 2025-523349-86-00 | Ph 3 | not yet recruiting | Use of the Methoxyflurane as Pain-killer in the Prehospital Management of Acute Myocardial Infarction |
| NCT07442877 | HSK21542-209 | Ph 2 | completed | A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery |
| NCT07425678 | ERC NUMBER- 2025-9126-34025 | Ph 4 | completed | Comparison of Systemic Opioid (Morphine) and Pre-Incision Bilateral Scalp Nerve Block for Pain Management in Craniotomy Patients |
| NCT04188418 | 2019-0701 NCI-2019-07529, 2019-0701 | Ph 3 | active not recruiting | Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients |
| NCT07412223 | 202601008 | Ph 4 | not yet recruiting | Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery |
| NCT07186426 | HSK21542-305 | Ph 3 | recruiting | A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery |
| NCT05006079 MAP | IRB-21-07-3844 | Ph 2 | recruiting | Opioid/Benzodiazepine Polydrug Abuse: Aim 3 |
| 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 |
| NCT06319859 | N-72-2024 | Ph 3 | completed | Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries |
| NCT03726268 OSPREy results posted | Pro00089977 1R01DA042985-01 | Ph 4 | completed | Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement) |
| NCT07229495 | K7767 | Ph 4 | not yet recruiting | Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery |
| NCT05069012 results posted | 2021P000688 | Ph 4 | completed | Intrathecal Morphine for Cesarean Delivery |
| NCT06479655 | USM/JEPeM/KK/24010062 | Ph 4 | recruiting | Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients |
| NCT06716749 | IRB-24-1831 | Ph 2 | completed | Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty |
| NCT06186141 POPCORN | 91523 | Ph 4 | recruiting | Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone |
| NCT02095366 ALGOFINE-2 | ALGOFINE-2 | Ph 4 | completed | Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting |
| NCT06192589 results posted | SCR-016 | Ph 1 | completed | Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions |
| NCT05017246 results posted | 202105007 | Ph 2 | terminated | Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy |
| NCT07054775 | HE631484 | Ph 4 | recruiting | Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section |
| NCT03396588 No-POPPY results posted | 11-0534-F34 1R01DA043519-01 | Ph 3 | completed | Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain |
| NCT05367336 results posted | EGME#04-2021 | Ph 2 | terminated | Platelet Reactivity With Fentanyl, Morphine, or no Narcotic |
| NCT06344169 | DTCRD112(2)-I-15 | Ph 2, Ph 3 | recruiting | Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section |
| NCT05913284 | 2022.636-T | Ph 3 | active not recruiting | Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients |
| NCT06315920 PASC | AFMS-MREC 009/2021 | Ph 3 | not yet recruiting | Analgesic Effect of Parecoxib Versus Morphine in SCD Patients Presenting to the Emergency Department |
| NCT04214834 results posted | ACTNOW-02 | Ph 3 | active not recruiting | Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) |
| NCT05236647 SIM | 2021/291056(REK) | Ph 3 | completed | Subcutaneous Versus Intravenous Morphine When Switching From Oral to Parenteral Route in Palliative Cancer Patients |
| NCT02473276 results posted | AAAP4755 | Ph 4 | completed | 2 Dose Neuraxial Morphine for Prevention of PDPH |
| NCT06458400 | TGRD-ANAL-PILOT-001 | Ph 4 | completed | To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain |
| NCT04528173 results posted | 19-016618 | Ph 4 | terminated | Opioid-Free Anesthetic for Tonsillectomy |
| NCT06728371 MethadoneRCT | CUHK_PWH | Ph 3 | recruiting | Intravenous Methadone for Sternotomy Pain Control in Cardiac Surgery |
| NCT04764825 METASPINE | 89456049 2020-004826-47 | Ph 4 | terminated | Methadone for Spinal Fusion Surgery. |
| NCT04448561 results posted | 8062-CL-2002 UG3DA051392 | Ph 1 | completed | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants |
| NCT05587998 results posted | D7460C00003 | Ph 1 | completed | A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users. |
| NCT03249558 Duloxetine results posted | 2017P001589 | Ph 4 | completed | Effect of Combined Morphine and Duloxetine on Chronic Pain |
| NCT06680466 | YZJ-4729-2-01 | Ph 2 | active not recruiting | A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery |
| NCT03092011 | 16-144 | Ph 4 | active not recruiting | Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy |
Showing 50 of 246 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
MORPHINE SULFATE FDA Label Details
Indications & Usage
FDA Label (PDF)Morphine sulfate tablets are indicated for the management of: adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, [see Warnings and Precautions ], reserve morphine sulfate tablets for use in patients for whom alternative t...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of morphine sulfate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s ...
MORPHINE SULFATE Patents & Exclusivity
Patents (3 active)
Pro Intelligence Preview
Deep insights for MORPHINE SULFATE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 100 active patents
Trial Analysis
- • 225 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment