Drug facts
MoleculeIbuprofen (Motrin IB)
Generics already compete: 32 makers on the market. 41 A-rated products from 13 makers substitute at the counter.
Motrin was first approved by the FDA before 1982 under NDA 017463; the application holder is Mcneil Consumer Healthcare Div Mcneil Ppc Inc. The Orange Book lists NDA 017463 as discontinued.
The latest NADAC for IBUPROFEN 600 MG TABLET is $0.05 per unit (as of 10/28/2026).
Holder Mcneil Consumer Healthcare Div Mcneil Ppc IncApplication NDA 017463Approved before 1982
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Motrin patent listed in the Orange Book Orange Book
- Later patents, other products
- Caldolor 03/16/2032 Orange Book
02Competition
- Generics
- 32 generic makers Orange Book
- First generic approved
- 02/08/1985 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Ibuprofen profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.05 per unitIBUPROFEN 600 MG TABLET, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 03/02/2026Class II, Ibuprofen, Strides Pharma Inc FDA enforcement
04Product
- Application holder
- Mcneil Consumer Healthcare Div Mcneil Ppc Inc Orange Book
- Application
- NDA 017463 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule; solution; suspension; suspension/drops; tablet; tablet, chewable
- Routes
- intravenous, oral
- Other brand names
- AdvilAdvil Liqui-GelsAdvil Migraine Liqui-GelsCaldolorChildren's AdvilChildren's Advil-Flavored
- Status
- NDA 017463 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.