Drug facts
MoleculeOxycodone Hydrochloride (Oxycontin)
Generics already compete: 18 makers on the market. 67 A-rated products from 18 makers substitute at the counter.
Roxicodone was first approved by the FDA on 10/26/1998 under NDA 020932; the application holder is Roxane Laboratories Inc. The Orange Book lists NDA 020932 as discontinued.
The latest NADAC for OXYCODONE HCL (IR) 15 MG TAB is $0.20 per unit (as of 10/28/2026).
Holder Roxane Laboratories IncApplication NDA 020932Approved 10/26/1998
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 Roxicodone patent listed in the Orange Book Orange Book
- Later patents, other products
- Oxycontin 03/29/2030; Roxybond 08/12/2028 Orange Book
02Competition
- Generics
- 18 generic makers Orange Book
- First generic approved
- 02/06/2004 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 Oxycodone Hydrochloride profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.20 per unitOXYCODONE HCL (IR) 15 MG TAB, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/14/2026Class II, Oxycodone Hydrochloride, Amerisource Health Services LLC FDA enforcement
04Product
- Application holder
- Roxane Laboratories Inc Orange Book
- Application
- NDA 020932 Orange Book
- First approved
- 10/26/1998 Orange Book
- Dosage forms
- capsule; solution; tablet; tablet, extended release
- Routes
- oral
- Other brand names
- RoxicodoneRoxybond
- Status
- NDA 020932 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.