Drug facts
MoleculeDexamethasone
Generics already compete: 14 makers on the market. 47 A-rated products from 13 makers substitute at the counter.
Decadron was first approved by the FDA before 1982 under NDA 011664; the application holder is Merck and Co Inc. The Orange Book lists NDA 011664 as discontinued.
Dexamethasone Sodium Phosphate Injection is on the current FDA drug shortage list, first posted 02/08/2019.
Holder Merck and Co IncApplication NDA 011664Approved 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 Decadron patent listed in the Orange Book Orange Book
- Later patents, other products
- Dextenza 04/26/2041; Dexycu Kit 06/23/2039; Hemady 12/18/2037 Orange Book
02Competition
- Generics
- 14 generic makers Orange Book
- 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 Dexamethasone profile.See what is included
03Supply and price
- FDA drug shortage
- ActiveDexamethasone Sodium Phosphate Injection is on the current shortage listsince 02/08/2019, available FDA shortages
- NADAC
- $0.18 per unitDEXAMETHASONE 1.5 MG TABLET, mid-priced of 7 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 12/22/2022Class II, Dexamethasone 16mg/Ml, Pharmacy Innovations FDA enforcement
04Product
- Application holder
- Merck and Co Inc Orange Book
- Application
- NDA 011664 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- concentrate; elixir; implant; insert; solution; suspension/drops
- Routes
- intravitreal, ophthalmic, oral
- Other brand names
- DextenzaHemadyMaxidexOzurdex
- Status
- NDA 011664 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.