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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

No clinical trials found on ClinicalTrials.gov for this drug

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)

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