CHILDREN'S MOTRIN Drug Patent 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. Fifteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Children's Motrin
A generic version of CHILDREN'S MOTRIN was approved as ibuprofen; pseudoephedrine hydrochloride by PERRIGO on November 5th, 2003.
Summary for CHILDREN'S MOTRIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 185 |
| Clinical Trials: | 6 |
| Patent Applications: | 6,661 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | CHILDREN'S MOTRIN at DailyMed |
Recent Clinical Trials for CHILDREN'S MOTRIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Le Bonheur Children's Hospital | Phase 4 |
| The Campbell Foundation | Phase 4 |
| University of Manitoba | Phase 2 |
Pharmacology for CHILDREN'S MOTRIN
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CHILDREN'S MOTRIN
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| J And J Consumer Inc | CHILDREN'S MOTRIN COLD | ibuprofen; pseudoephedrine hydrochloride | SUSPENSION;ORAL | 021128-001 | Aug 1, 2000 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | SUSPENSION;ORAL | 020516-001 | Jun 16, 1995 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020601-001 | Nov 15, 1996 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | See Plans and Pricing | See Plans and Pricing |
| J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020601-001 | Nov 15, 1996 | See Plans and Pricing | See Plans and Pricing |
| J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | SUSPENSION;ORAL | 020516-001 | Jun 16, 1995 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for CHILDREN'S 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for CHILDREN'S MOTRIN
See the table below for patents covering CHILDREN'S MOTRIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 0161969 | See Plans and Pricing | |
| Ireland | 69042 | Rotogranulations and taste masking coatings for preparation of chewable pharmaceutical tablets | See Plans and Pricing |
| Portugal | 94504 | PROCESSO PARA A PREPARACAO DE COMPOSICOES FARMACEUTICAS AQUOSAS EM SUSPENSAO PARA INGREDIENTES ACTIVOS SUBSTANCIALMENTE INSOLUVEIS EM AGUA | See Plans and Pricing |
| Israel | 94887 | Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives | See Plans and Pricing |
| 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.) | See Plans and Pricing |
| Ireland | 902823 | See Plans and Pricing | |
| Ireland | 902332 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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