Viewing data from:

CHILDREN'S MOTRIN

NDA

IBUPROFEN | N020516 | KENVUE BRANDS 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5975 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition seeking FDA approval or recognition of a particular manufacturing process, facility condition, or analytical method as suitable for regulatory compliance purposes. The petition requested that the FDA confirm the adequacy of specified proced	Suitability	2026-05-27	DeniedDecision letter not yet read	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

456 trials from ClinicalTrials.gov — 15 recruiting, 3 active, 326 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pentoxifylline and Lumbar Radiculopathy NCT03060434	Phase 4	Active	St Joseph University, Beirut, Lebanon	67	2018-06-01 → 2026-12-01
Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy NCT07768514	Phase 2	Active	Seoul National University Bundang Hospital	90	2025-11-21 → 2026-12-25
RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee NCT05318521	Phase 3	Active	Overseas Pharmaceuticals, Ltd.	500	2021-12-10 → 2026-12-31
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
Effect of Nonsteroidal Anti-Inflammatory Drug Restriction on the Efficacy of Platelet-Rich Plasma in Knee Osteoarthritis NCT07766330	N/A	Not Yet Recruiting	Federal University of São Paulo	90	2026-10-01 → 2028-10
Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery NCT07571252	Phase 4	Not Yet Recruiting	University of Puerto Rico	72	2026-09 → 2027-02
Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management NCT07682558	Phase 3	Not Yet Recruiting	University Hospital, Basel, Switzerland	318	2026-10 → 2029-11
Pain Control During ESWL Using Non-Opioid Analgesics NCT07512297	Phase 4	Not Yet Recruiting	University of Gaziantep	160	2026-10-01 → 2027-03-01
Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia NCT06757075	Phase 4	Recruiting	Boston University	75	2025-04-16 → 2027-03
Supracondylar Post-Operative Pain Study NCT03759028	Phase 4	Recruiting	University of California, Los Angeles	90	2019-02-26 → 2027-12-20

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

API Supply Chain17 active DMFs34 inactive

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

SI GROUPIBUPROFEN

DMF 53811984

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN USP

DMF 70531987

BASF CORPIBUPROFEN

DMF 87091990

ADARE PHARMACEUTICALS INCIBUPROFEN GELATIN/CAP

DMF 101651993

SHANDONG XINHUA PHARMACEUTICAL CO LTDIBUPROFEN

DMF 155112001

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDIBUPROFEN USP

DMF 158392002

ZIBO XINHUA PERRIGO PHARMACEUTICAL CO LTDIBUPROFEN USP DRUG SUBSTANCE

DMF 184132005

BASF CORPIBUPROFEN DC 85

DMF 204212007

DIPHARMA FRANCIS SRLIBUPROFEN LYSINE SALT

DMF 214442008

IOL CHEMICALS AND PHARMACEUTICALS LTDIBUPROFEN USP

DMF 224312009

IPC PROCESS CENTER GMBH AND CO KGIBUPROFEN DC100 (IBUPROFEN PH. EUR., GRANULATED)

DMF 232422009

SMS PHARMACEUTICALS LTDIBUPROFEN USP

DMF 352152020

LUNA CHEMICAL INDUSTRIES PVT LTDIBUPROFEN USP

DMF 369352022

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN ARGININE

DMF 369922022

SHIJIAZHUANG CREADY PHARMACEUTICAL R AND D INCIBUPROFEN GRANULES DC 85%

DMF 388092023

SMS PHARMACEUTICALS LTDIBUPROFEN ARGININE

DMF 418492025

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDIBUPROFEN ARGININE DRUG SUBSTANCE

DMF 418862025

KNOLL PHARMA CHEMICALSInactiveIBUPROFEN

DMF 20781973

ETHYL CORPInactiveIBUPROFEN

DMF 29071977

BLASCHIM SPAInactiveIBUPROFEN

DMF 44401982

INDUSTRIA CHEMICA PRODOTTI FRANCIS SPAInactiveIBUPROFEN USP

DMF 45941982

FOREST LABORATORIES INCInactiveIBUPROFEN 800 MG C.R. TABLETS (IN SYNCHRON VEHICLE)

DMF 46441982

INDUSTRIAS QUIMICAS ESTEVE SAInactiveIBUPROFEN

DMF 51661983

ORION CORPInactiveIBUPROFEN

DMF 52051984

YONEZAWA HAMARI CHEMICALS LTDInactiveIBUPROFEN

DMF 53921984

CIPLA LTDInactiveIBUPROFEN USP AS PROCESSED IN FACTORIES NO.2, NO. 3, NO.4 CITED IN DMF

DMF 54381984

ZAMBON SPAInactiveIBUPROFEN USP XX

DMF 54851984

ORION CORP FARMOS CHEMICAL PLANTInactiveIBUPROFEN,200 MG TABLETS

DMF 55521984

DM GRAHAM LABORATORIES INCInactiveIBUPROFEN TIMED-RELEASE 600 MG. TALBETS

DMF 60371985

ELAN CORP PLCInactiveIBUPROFEN CAPSULES

DMF 61901986

ELAN CORP PLCInactiveIBUPROFEN 300MG. LA CAPSULES

DMF 62101986

ANTIBIOTICOS SPAInactiveIBUPROFEN

DMF 65311986

HEXAGON LABORATORIES INCInactiveIBUPROFEN USP

DMF 65881986

KV PHARMACEUTICAL COInactiveIBUPROFEN DIHYDROCODEINE F.C. TABLETS

DMF 66021986

DR REDDYS LABORATORIES LTDInactiveIBUPROFEN

DMF 66691986

ETHYL CHEMICALS GROUPSInactiveIBUPROFEN

DMF 69271987

MALLINCKRODT CHEMICAL INCInactiveIBUPROFEN DCI-63

DMF 70751987

RALLIS INDIA LTDInactiveIBUPROFEN U.S.P.

DMF 72961987

CHANDRA PHARMACEUTICALS LTDInactiveIBUPROFEN

DMF 77881988

DM GRAHAM LABORATORIES INCInactiveIBUPROFEN S (+) TABLETS

DMF 87271990

SUMITRA PHARMACEUTICALS AND CHEMICALS LTDInactiveIBUPROFEN

DMF 87551990

ARCH PHARMALABS LTDInactiveIBUPROFEN

DMF 91191991

BDH PHARMACEUTICALS LTDInactiveIBUPROFEN BULK DRUG SUBSTANCES

DMF 92381991

CATALENT PHARMA SOLUTIONS LLCInactiveIBUPROFEN SOFTGELS, 200 MG.

DMF 104991993

UNITED BREWERIES LTDInactiveIBUPROFEN USP

DMF 112021994

SHANDONG XIN HUA PHARMACEUTICAL FACTORYInactiveIBUPROFEN BP 88/USP XXII

DMF 112431994

WANBURY LTDInactiveIBUPROFEN BULK DRUG

DMF 126691997

PIRAMAL ENTERPRISES LTDInactiveIBUPROFEN

DMF 143531999

JUHUA GROUP CORP PHARMACEUTICAL FACTORYInactiveIBUPROFEN

DMF 158592002

WANBURY LTDInactiveIBUPROFEN DC GRADE-65%

DMF 199992006

WANBURY LTDInactiveIBUPROFEN DC GRADE-90%

DMF 200432006

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Jul 24, 2026	SUPPL -45	View Letter (PDF)
Jun 16, 2021	SUPPL -38	View Letter (PDF)
Dec 19, 2018	SUPPL -36	View Letter (PDF)
Mar 20, 2017	SUPPL -35	View Letter (PDF)
Jun 21, 2016	SUPPL -33	View Letter (PDF)
Apr 17, 2015	SUPPL -30	View Letter (PDF)
Dec 12, 2014	SUPPL -29	View Letter (PDF)
Dec 8, 2011	SUPPL -24	View Letter (PDF)
Oct 22, 2010	SUPPL -22	View Letter (PDF)
May 6, 2009	SUPPL -21	View Letter (PDF)
Jun 28, 2006	SUPPL -20	View Letter (PDF)
Dec 15, 2005	SUPPL -18	View Letter (PDF)
Feb 9, 2005	SUPPL -16	View Letter (PDF)
Dec 23, 2003	SUPPL -12	View Letter (PDF)
Oct 31, 2003	SUPPL -11	View Letter (PDF)
Sep 13, 1999	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/5ML

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jun 16, 1995

No patent or exclusivity listings for this strength.