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NDA

IBUPROFEN SODIUM | N201803 | HALEON US HOLDINGS LLC

1 strength0 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

5 trials from ClinicalTrials.gov — 5 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain NCT07225634	Phase 3	Not Yet Recruiting	AFT Pharmaceuticals, Ltd.	60	2026-09 → 2027-04
A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery NCT07225140	Phase 3	Not Yet Recruiting	AFT Pharmaceuticals, Ltd.	180	2026-10 → 2027-10
Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen NCT07672418	—	Not Yet Recruiting	Baylor College of Medicine	200	2026-06-24 → 2027-06-30
Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients NCT07265557	N/A	Recruiting	Massachusetts General Hospital	100	2025-10-06 → 2026-12-31
A Study to Evaluate Ibuprofen (IBU) 62.5 mg and Acetaminophen (APAP) 125 mg/5 ml in an Oral Liquid Suspension Fixed-Dose Combination Product in Children Aged 6 to 11 Years NCT07632274	Phase 1	Recruiting	HALEON	12	2026-06-19 → 2026-09

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

API Supply Chain4 active DMFs1 inactive

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

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN SODIUM DIHYDRATE

DMF 183122005

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN SODIUM DIHYDRATE

DMF 239252010

SHANDONG XINHUA PHARMACEUTICAL CO LTDIBUPROFEN SODIUM

DMF 284032014

SMS PHARMACEUTICALS LTDIBUPROFEN SODIUM DIHYDRATE

DMF 394732024

SI GROUPInactiveIBUPROFEN SODIUM DIHYDRATE

DMF 237552010

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

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 200MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 12, 2012

No patent or exclusivity listings for this strength.