MOTRIN Drug Patent Profile

Which patents cover Motrin, and what generic alternatives are available?

Motrin is a drug marketed by Mcneil, Mcneil Consumer, Mcneil Ped, and Kenvue Brands. and is included in seven NDAs.

The generic ingredient in MOTRIN is ibuprofen. There is one drug master file entry for this compound. Two hundred and forty-nine suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Motrin

A generic version of MOTRIN was approved as ibuprofen by CONTRACT PHARMACAL on October 15^th, 1986.

Summary for MOTRIN

US Patents:	0
Applicants:	4
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	74
Patent Applications:	3,982
What excipients (inactive ingredients) are in MOTRIN?	MOTRIN excipients list
DailyMed Link:	MOTRIN at DailyMed

See drug sales revenues for MOTRIN

Recent Clinical Trials for MOTRIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Miami	Phase 2
Guangzhou Kangqi Medical Technology Co., LTD	Phase 1
Weill Medical College of Cornell University	Phase 4

See all MOTRIN clinical trials

Paragraph IV (Patent) Challenges for MOTRIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOTRIN	Intravenous	ibuprofen	1000 mg/50 mL 2000 mg/100 mL	020418	2	2025-08-26

US Patents and Regulatory Information for MOTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mcneil	MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020476-001	May 25, 1995		DISCN	No	No
Mcneil Consumer	MOTRIN	ibuprofen	TABLET;ORAL	017463-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994		DISCN	No	No
Kenvue Brands	MOTRIN MIGRAINE PAIN	ibuprofen	TABLET;ORAL	019012-004	Feb 25, 2000		DISCN	No	No
Mcneil Consumer	MOTRIN	ibuprofen	TABLET;ORAL	017463-005	May 22, 1985		DISCN	Yes	No
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989		DISCN	Yes	No
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994		DISCN	No	No

EU/EMA Drug Approvals for MOTRIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Rare Diseases	Pedea	ibuprofen	EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.	Authorised	no	no	no	2004-07-28

International Patents for MOTRIN

See the table below for patents covering MOTRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	110259
Australia	5792690
Australia	635283
Canada	2019863	SUSPENSION AQUEUSE PHARMACEUTIQUE POUR DES INGREDIENTS ACTIFS PHARMACEUTIQUES PEU HYDROSOLUBLES (AQUEOUS PHARMACEUTICAL SUSPENSION FOR SUBSTANTIALLY WATER INSOLUBLE PHARMACEUTICAL ACTIVES)
Germany	69011766
European Patent Office	0405930	Suspension pharmaceutique aqueuse pour des agents actifs pharmaceutiques essentiellement insolubles dans l'eau. (Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives.)
Spain	2064634

Supplementary Protection Certificates for MOTRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726