Drug facts
MoleculeMethylprednisolone (Medrol)
Generics already compete: 6 makers on the market. 12 A-rated products from 6 makers substitute at the counter.
Medrol was first approved by the FDA before 1982 under NDA 011153; the application holder is Pfizer Inc.
Methylprednisolone Acetate Injection is on the current FDA drug shortage list, first posted 12/15/2021.
Holder Pfizer IncApplication NDA 011153Approved 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 Medrol patent listed in the Orange Book Orange Book
02Competition
- Generics
- 6 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 Methylprednisolone profile.See what is included
03Supply and price
- FDA drug shortage
- ActiveMethylprednisolone Acetate Injection is on the current shortage listsince 12/15/2021, limited availability FDA shortages
- NADAC
- $0.92 per unitMETHYLPREDNISOLONE 8 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/15/2026Class II, Methylprednisolone, Greenstone LLC FDA enforcement
04Product
- Application holder
- Pfizer Inc Orange Book
- Application
- NDA 011153 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- tablet
- Routes
- oral
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.