Drug facts
MoleculeAcetaminophen and Oxycodone
Generics already compete: 17 makers on the market. 51 A-rated products from 16 makers substitute at the counter.
Xartemis XR was first approved by the FDA on 03/11/2014 under NDA 204031; the application holder is Mallinckrodt Inc. The Orange Book lists NDA 204031 as discontinued.
The latest NADAC for OXYCODONE-ACETAMINOPHEN 7.5-325 MG TABLET is $0.18 per unit (as of 10/28/2026).
Holder Mallinckrodt IncApplication NDA 204031Approved 03/11/2014
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.
2,024days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved03/11/2014
Last patent05/16/2032
2015201820212024202720302033
- Latest patent
- 05/16/2032Xartemis XR Orange Book
02Competition
- Generics
- 17 generic makers Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
- First generic approved
- before 1982 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 Acetaminophen and Oxycodone profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.18 per unitOXYCODONE-ACETAMINOPHEN 7.5-325 MG TABLET, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 12/16/2025Class II, Oxycodone Hydrochloride and Acetaminophen, Specgx, LLC FDA enforcement
04Product
- Application holder
- Mallinckrodt Inc Orange Book
- Application
- NDA 204031 Orange Book
- First approved
- 03/11/2014 Orange Book
- Dosage forms
- solution; tablet
- Routes
- oral
- Other brand names
- OxycetPercocet
- Status
- NDA 204031 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.