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 J And J Consumer Inc. and is included in six NDAs.

The generic ingredient in MOTRIN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and thirty-eight 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 STRIDES PHARMA on September 24^th, 1986.

Summary for MOTRIN

US Patents:	0
Applicants:	4
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	207
Clinical Trials:	73
Patent Applications:	3,320
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

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
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

Expired US Patents for MOTRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994

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/000549 Treatment 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
Greece	900100481
South Korea	0161969
Greece	1002094	PROCESS FOR THE PREPARATION OF AQUEOUS SUSPENSION FOR SUBSTANTIALLY WATER IN SOWBLE ACTIVES
Hong Kong	127494	Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives
Portugal	94898	PROCESSO PARA A PREPARACAO DE PASTILHAS MEDICAMENTOSAS DE MASCAR ROTOGRANULADAS E COBERTAS POR REVESTIMENTO PARA MASCARAR O SABOR
Ireland	64400	Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives

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