MOTRIN IB Drug Patent Profile
Which patents cover Motrin Ib, and when can generic versions of Motrin Ib launch?
Motrin Ib is a drug marketed by Kenvue Brands and is included in two NDAs.
The generic ingredient in MOTRIN IB is ibuprofen. There is one drug master file entry for this compound. Two hundred and fifty-two suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Motrin Ib
A generic version of MOTRIN IB was approved as ibuprofen by CONTRACT PHARMACAL on October 15th, 1986.
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Questions you can ask:
- What is the 5 year forecast for MOTRIN IB?
- What are the global sales for MOTRIN IB?
- What is Average Wholesale Price for MOTRIN IB?
Summary for MOTRIN IB
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 74 |
| Patent Applications: | 4,017 |
| What excipients (inactive ingredients) are in MOTRIN IB? | MOTRIN IB excipients list |
| DailyMed Link: | MOTRIN IB at DailyMed |
Recent Clinical Trials for MOTRIN IB
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 |
Pharmacology for MOTRIN IB
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for MOTRIN IB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kenvue Brands | MOTRIN IB | ibuprofen | SUSPENSION;ORAL | 020516-002 | Jul 22, 2026 | OTC | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Kenvue Brands | MOTRIN IB | ibuprofen | TABLET;ORAL | 019012-003 | Dec 17, 1990 | OTC | 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 |
EU/EMA Drug Approvals for MOTRIN IB
| 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for MOTRIN IB
See the table below for patents covering MOTRIN IB around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 110259 | ⤷ Start Trial | |
| Australia | 5792690 | ⤷ Start Trial | |
| Australia | 635283 | ⤷ Start Trial | |
| Canada | 2019863 | SUSPENSION AQUEUSE PHARMACEUTIQUE POUR DES INGREDIENTS ACTIFS PHARMACEUTIQUES PEU HYDROSOLUBLES (AQUEOUS PHARMACEUTICAL SUSPENSION FOR SUBSTANTIALLY WATER INSOLUBLE PHARMACEUTICAL ACTIVES) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOTRIN IB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781277 | PA2024501 | Lithuania | ⤷ Start Trial | PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |

