Viewing data from:

NUPRIN

NDA

IBUPROFEN | N019012 | KENVUE BRANDS LLC

4 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Actavis Mid-Atlantic LLC - Citizen Petition FDA-2010-P-0145 · 8 docket documents Actavis Mid-Atlantic LLC filed this citizen petition on March 12, 2010, requesting that the FDA determine that a new dosage form of ibuprofen—Adult Ibuprofen Oral Suspension, 100 mg/5 mL—is suitable for submission as an ANDA using McNeil's Motrin IB Tablets, 200 mg as the reference listed drug under	Other	2010-03-17	Denied	—
Fuisz Technologies Ltd. - Withdrawal FDA-1996-P-0383 · 4 docket documents Fuisz Technologies Ltd. withdrew its citizen petition filed on November 7, 1996, requesting FDA suitability determination under the ANDA pathway for a new oral dosage form of ibuprofen 200 mg, specifically an Oral Spoon Dose Sachet based on the listed drug Nuprin Tablets 200 mg.	Other	2009-12-28	Open	—

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

Clinical Trials

439 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 321 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
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management NCT04059172	Early Phase 1	Recruiting	University of Colorado, Denver	375	2019-12-10 → 2028-06-01
Supracondylar Post-Operative Pain Study NCT03759028	Phase 4	Recruiting	University of California, Los Angeles	90	2019-02-26 → 2027-12-20
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery NCT03858231	Phase 4	Recruiting	Sanford Health	148	2018-10-29 → 2028-01
Optimizing Pain Control in Transurethral Resection of the Prostate NCT04102566	Phase 4	Recruiting	Benaroya Research Institute	50	2017-12-08 → 2019-12-01
Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD NCT03055247	Phase 2	Recruiting	IRCCS San Raffaele	3	2015-11-06 → 2026-07-18
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription NCT03588910	Phase 2	Completed	Montefiore Medical Center	120	2018-08-08 → 2019-08-04
Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars NCT03785756	Phase 3	Completed	Reckitt Benckiser Healthcare (UK) Limited	280	2019-04-29 → 2020-02-28
Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment.NCT02815189	Phase 2	Completed	Universidad Autonoma de Baja California	110	2014-02 → 2016-05
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS NCT03852459	Phase 2	Completed	Aponia Laboratories, Inc.	251	2018-01-12 → 2019-04-11

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

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 D

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

12 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2021	SUPPL -59	View Letter (PDF)
Apr 28, 2021	SUPPL -58	View Letter (PDF)
Mar 20, 2017	SUPPL -57	View Letter (PDF)
Mar 20, 2017	SUPPL -56	View Letter (PDF)
Aug 18, 2016	SUPPL -55	View Letter (PDF)
Oct 26, 2010	SUPPL -46	View Letter (PDF)
May 1, 2009	SUPPL -43	View Letter (PDF)
Nov 26, 2007	SUPPL -40	View Letter (PDF)
Dec 28, 2006	SUPPL -38	View Letter (PDF)
Feb 22, 2006	SUPPL -37	View Letter (PDF)
Oct 31, 2003	SUPPL -34	View Letter (PDF)
Feb 25, 2000	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#003 — 200MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 17, 1990

#004 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 25, 2000

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 18, 1984

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 29, 1987