Viewing data from:

CODEINE SULFATE

NDA

CODEINE SULFATE | N022402 | HIKMA PHARMACEUTICALS USA INC

3 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

51 trials from ClinicalTrials.gov, 43 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery NCT03049878	Phase 4	Completed	University of Roma La Sapienza	32	2013-02-21 → 2016-09-10
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)NCT00694369	Phase 3	Completed	Organon and Co	588	2008-06 → 2009-01
Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study NCT02572375	Phase 1	Completed	Nexgen Pharma, Inc	38	2014-10 → 2015-01
Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions NCT01010139	N/A	Completed	Roxane Laboratories	18	2006-08 → 2006-09
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)NCT02439034	Phase 2	Completed	Centre Oscar Lambret	68	2015-02 → 2016-10
Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain NCT04066426	Phase 4	Completed	Yuzuncu Yil University	200	2018-03-01 → 2019-07-15
Codeine in Sickle Cell Disease NCT00174538	Phase 1/2	Completed	PriCara, Unit of Ortho-McNeil, Inc.	60	2005-03 → 2005-12
A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis NCT00784810	Phase 4	Completed	Napp Pharmaceuticals Limited	247	2009-02 → 2011-06
Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg NCT02902666	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A	46	2016-04 → 2016-05
Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics NCT01845194	Phase 1	Completed	Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH	117	2009-12 → 2013-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$1.24

per ea

Lowest NADAC/Unit

$0.6811

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054024525CODEINE SULFATE 60 MG TABLET	$1.24	EA	Generic	—	2026-08-19
00054024424CODEINE SULFATE 30 MG TABLET	$0.6951	EA	Generic	—	2026-08-19
00054024425CODEINE SULFATE 30 MG TABLET	$0.6951	EA	Generic	—	2026-08-19
00054024324CODEINE SULFATE 15 MG TABLET	$0.6811	EA	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$83.47

Highest Price

$83.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-0245-25CODEINE SO4 60MG TAB	$83.47	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026

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

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SPECGX LLCCODEINE SULFATE USP POWDER

DMF 211172007

MALLINCKRODT INCInactiveCODEINE SULFATE

DMF 52331984

PENICK CORPInactiveCODEINE SULFATE

DMF 93681991

NORAMCO DELAWARE INCInactiveCODEINE SULFATE

DMF 101591993

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 -19	View Letter (PDF)
Dec 31, 2025	SUPPL -17	View Letter (PDF)
Nov 4, 2024	SUPPL -16	View Letter (PDF)
Dec 19, 2023	SUPPL -15	View Letter (PDF)
Mar 8, 2021	SUPPL -14	View Letter (PDF)
Oct 8, 2019	SUPPL -12	View Letter (PDF)
Oct 1, 2018	SUPPL -11	View Letter (PDF)
Oct 1, 2018	SUPPL -10	View Letter (PDF)
Aug 31, 2017	SUPPL -9	View Letter (PDF)
Dec 21, 2016	SUPPL -8	View Letter (PDF)
May 14, 2013	SUPPL -6	View Letter (PDF)
Apr 19, 2012	SUPPL -3	View Letter (PDF)
Jul 22, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 15MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 16, 2009

No patent or exclusivity listings for this strength.

#002 — 30MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 16, 2009

#003 — 60MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 16, 2009