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COMBOGESIC IV

NDA

ACETAMINOPHEN; IBUPROFEN SODIUM | N215320 | HIKMA PHARMACEUTICALS USA INC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Jan. 14, 2036

Jul. 17, 2035

Oct. 26, 2031

Oct. 26, 2031

Jul. 17, 2035

Oct. 26, 2031

Oct. 17, 2026

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

26 trials from ClinicalTrials.gov, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Non-opioid Based Pain Control After Thyroidectomy NCT03988075	N/A	Completed	Medstar Health Research Institute	100	2018-07-24 → 2019-09-30
Narcotic vs. Non-narcotic Pain Study Protocol NCT01974609	Phase 4	Completed	Horizon Health Network	347	2016-03 → 2022-02-24
T3AI-Pain After Breast Surgery NCT00299039	Phase 3	Completed	Nova Scotia Health Authority	150	2006-05 → 2008-09
Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients NCT04271917	Phase 3	Completed	University of Tennessee	68	2020-02-24 → 2022-03-31
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain NCT01559259	Phase 2	Completed	Pfizer	394	2012-04-10 → 2012-09-13
Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy NCT03631433	Phase 4	Completed	Ohio State University	102	2016-02-10 → 2017-07-17
Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children NCT01359020	Phase 4	Completed	Mantecorp Industria Quimica e Farmaceutica Ltd.	396	2007-01 → 2008-03
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study NCT01229449	Phase 3	Completed	Reckitt Benckiser LLC	678	2009-01 → 2009-09
A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain NCT02912650	Phase 3	Completed	Pfizer	568	2015-09 → 2016-06
A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers NCT02761980	Phase 3	Completed	Pfizer	290	2016-12-06 → 2017-12-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$50.25

Highest Price

$50.25

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00143-9150-10ACETAMINOPHEN 10MG/ML/IBUPROFEN 3MG/ML INJ,SO	$50.25	Big4	Hikma Pharmaceuticals USA Inc.	08/14/2026
00143-9150-10ACETAMINOPHEN 10MG/ML/IBUPROFEN 3MG/ML INJ,SO	$50.25	FSS	Hikma Pharmaceuticals USA Inc.	08/14/2026

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2024	SUPPL -1	View Letter (PDF)
Oct 18, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)

RLD

6 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Oct 17, 2023

Patents (6) · 8 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11213498	Jan 14, 2036	—	—	Yes	—	—
11389416	Jul 17, 2035	—	—	Yes	—	—
11446266	Oct 26, 2031	—	—	—		—
11896567	Oct 26, 2031	—	—	—		—
12083087	Jul 17, 2035	—	—	—		—
12220392	Oct 26, 2031	—	—	—		—

Exclusivities (1)

Code	Date	Status
NP	Oct 17, 2026	< 1 year