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Last Updated: July 6, 2020

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CHILDREN'S MOTRIN Drug Profile


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Which patents cover Children's Motrin, and when can generic versions of Children's Motrin launch?

Children's Motrin is a drug marketed by J And J Consumer Inc and is included in four NDAs.

The generic ingredient in CHILDREN'S MOTRIN is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Drug patent expirations by year for CHILDREN'S MOTRIN
Recent Clinical Trials for CHILDREN'S MOTRIN

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

SponsorPhase
University of Western Ontario, CanadaPhase 2
Centre hospitalier de l'Université de Montréal (CHUM)Phase 2
University of ManitobaPhase 2

See all CHILDREN'S MOTRIN clinical trials

Paragraph IV (Patent) Challenges for CHILDREN'S MOTRIN
Tradename Dosage Ingredient NDA Submissiondate
CHILDREN'S MOTRIN TABLET, CHEWABLE;ORAL ibuprofen 020601
JUNIOR STRENGTH MOTRIN TABLET, CHEWABLE;ORAL ibuprofen 020601
CHILDREN'S MOTRIN SUSPENSION/DROPS;ORAL ibuprofen 020603

US Patents and Regulatory Information for CHILDREN'S MOTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION/DROPS;ORAL 020603-001 Jun 10, 1996 OTC Yes Yes   Start Trial   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021128-001 Aug 1, 2000 OTC Yes Yes   Start Trial   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516-001 Jun 16, 1995 OTC Yes Yes   Start Trial   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-001 Nov 15, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CHILDREN'S MOTRIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION/DROPS;ORAL 020603-001 Jun 10, 1996   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-001 Nov 15, 1996   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516-001 Jun 16, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
McKinsey
Merck
Baxter
Medtronic

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