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MORPHINE SULFATE

NDA

MORPHINE SULFATE | N022207 | HIKMA PHARMACEUTICALS USA INC

2 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

452 trials from ClinicalTrials.gov — 2 recruiting, 7 active, 300 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
Cordotomy in Reducing Pain in Patients With Advanced Cancer NCT04119037	N/A	Active	M.D. Anderson Cancer Center	27	2019-09-16 → 2028-12-01
Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain NCT04011163	Phase 2/3	Active	KK Women's and Children's Hospital	40	2021-03-31 → 2025-12-31
Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia NCT02804022	Phase 2	Active	KK Women's and Children's Hospital	20	2016-12-29 → 2025-12-31
Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty NCT03774836	Phase 3	Active	Avenue Therapeutics, Inc.	360	2018-12-14 → 2019-06-30
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients NCT04188418	Phase 3	Active	M.D. Anderson Cancer Center	150	2020-10-23 → 2027-08-31
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy NCT03092011	Phase 4	Active	The Cooper Health System	69	2018-02-21 → 2026-12-01
Spinal Anesthesia For Enhanced Recovery After Liver Surgery NCT03715517	N/A	Recruiting	University of Manitoba	128	2018-10-04 → 2031-12-31
Post-Op Pain Control for Prophylactic Intramedullary Nailing.NCT03823534	Phase 3	Recruiting	St. Louis University	60	2019-02-20 → 2027-03-31
Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine NCT04369950	Phase 4	Completed	The University of Texas Health Science Center, Houston	44	2020-05-11 → 2021-07-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.4148

per ea

Lowest NADAC/Unit

$0.2354

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054023624MORPHINE SULFATE IR 30 MG TAB	$0.4148	EA	Generic	—	2026-06-17
00054023625MORPHINE SULFATE IR 30 MG TAB	$0.4148	EA	Generic	—	2026-06-17
00054023524MORPHINE SULFATE IR 15 MG TAB	$0.2354	EA	Generic	—	2026-06-17
00054023525MORPHINE SULFATE IR 15 MG TAB	$0.2354	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$41.05

Highest Price

$122.23

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-0235-24MORPHINE SO4 15MG TAB,UD	$71.99	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-0236-24MORPHINE SO4 30MG TAB,UD	$122.23	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-0235-25MORPHINE SO4 15MG TAB	$41.05	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-0236-25MORPHINE SO4 30MG TAB	$69.85	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs6 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

NORAMCO LLCMORPHINE SULFATE, USP

DMF 293172015

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

CODY LABORATORIES INCInactiveMORPHINE SULFATE, USP

DMF 280402014

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -16	View Letter (PDF)
Dec 31, 2025	SUPPL -14	View Letter (PDF)
Nov 4, 2024	SUPPL -13	View Letter (PDF)
Dec 19, 2023	SUPPL -11	View Letter (PDF)
Jun 3, 2021	SUPPL -5	View Letter (PDF)
Mar 5, 2021	SUPPL -10	View Letter (PDF)
Oct 8, 2019	SUPPL -9	View Letter (PDF)
Oct 1, 2018	SUPPL -8	View Letter (PDF)
Oct 1, 2018	SUPPL -7	View Letter (PDF)
Dec 20, 2016	SUPPL -6	View Letter (PDF)
Jan 25, 2012	SUPPL -4	View Letter (PDF)
Apr 21, 2010	SUPPL -2	View Letter (PDF)
Mar 19, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 17, 2008

No patent or exclusivity listings for this strength.

#002 — 30MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 17, 2008