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DURAMORPH PF

NDA

MORPHINE SULFATE | N018565 | HIKMA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

12 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)NCT04214834	Phase 3	Active	Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program	189	2020-09-28 → 2026-06-30
Combined SPSP and TTP Blocks for Postoperative Analgesia Post-CABG NCT07658521	N/A	By Invitation	Ain Shams University	88	2026-07-01 → 2027-01-15
Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part B NCT07666009	N/A	Not Yet Recruiting	Centre Hospitalier Universitaire Vaudois	100	2026-06 → 2027-09
tDCS for Reducing the Incidence of OEI After Cesarean Section NCT07569783	N/A	Not Yet Recruiting	Affiliated Hospital of Nantong University	104	2026-06-15 → 2027-02-20
Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part A NCT07666971	N/A	Not Yet Recruiting	Centre Hospitalier Universitaire Vaudois	100	2026-06 → 2027-09
Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department NCT07430345	Phase 1/2	Recruiting	The Cooper Health System	48	2026-05-07 → 2027-01
Satisfactory Analgesia Minimal Emesis in Day Surgeries NCT02223377	N/A	Completed	McMaster University	402	2015-01 → 2019-03
Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors NCT07233096	N/A	Completed	Istinye University	64	2025-12-22 → 2026-06-15
The Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Analgesia in Percutaneous Nephrolithotomy NCT07672600	N/A	Completed	Istanbul University	56	2019-10-01 → 2021-04-30
A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery NCT06680466	Phase 2	Completed	Shanghai Haiyan Pharmaceutical Technology Co., Ltd.	179	2023-12-26 → 2024-08-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Morphine Sulfate ER (2023)

Total Spending

$66.1M

Total Claims

2,003,652

Beneficiaries

255,247

Avg Cost/Unit

$0.54

Spending Trend

$103.4M(2019)→$24.9M(2019)→$91.2M(2020)→$23.8M(2020)→$90.7M(2021)→$20.7M(2021)→$19.7M(2022)→$83.0M(2022)→$66.1M(2023)→$18.6M(2023)

YoY Change:-15.2%

5yr CAGR:-3.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -36	View Letter (PDF)
Dec 29, 2025	SUPPL -35	View Letter (PDF)
Dec 19, 2023	SUPPL -27	View Letter (PDF)
Dec 19, 2023	SUPPL -30	View Letter (PDF)
Dec 19, 2023	SUPPL -28	View Letter (PDF)
Dec 19, 2023	SUPPL -31	View Letter (PDF)
Nov 13, 2023	SUPPL -29	View Letter (PDF)
Oct 9, 2019	SUPPL -24	View Letter (PDF)
Dec 22, 2016	SUPPL -22	View Letter (PDF)
Dec 19, 2016	SUPPL -22	View Letter (PDF)
Oct 5, 2010	SUPPL -20	View Letter (PDF)
Jun 8, 2005	SUPPL -14	View Letter (PDF)
Jun 1, 2004	SUPPL -12	View Letter (PDF)
Jul 6, 2003	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.5MG/ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 18, 1984

No patent or exclusivity listings for this strength.

#002 — 1MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 18, 1984

#003 — 10MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 19, 1991

#004 — 25MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 19, 1991