Drug facts
MoleculeZoledronic Acid
Generics already compete: 15 makers on the market. 24 A-rated products from 15 makers substitute at the counter.
Zometa was first approved by the FDA on 08/20/2001 under NDA 021223; the application holder is Novartis Pharmaceuticals Corp. The Orange Book lists NDA 021223 as discontinued.
The latest NADAC for ZOLEDRONIC ACID 5 MG/100 ML is $0.47 per mL (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 021223Approved 08/20/2001
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.
462days until the latest Zometa patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved08/20/2001
Last patent02/05/2028
20022006201020142018202220262030
- Latest patent
- 02/05/2028Zometa Orange Book
- Later patents, other products
- Reclast 08/05/2028 Orange Book
02Competition
- Generics
- 15 generic makers Orange Book
- Staged generics
- 11 passed FDA review, awaiting market entry FDA
- First generic approved
- 03/04/2013 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 Zoledronic Acid profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.47 per mLZOLEDRONIC ACID 5 MG/100 ML, as of 10/28/2026 CMS NADAC
- Latest recall
- 05/23/2024Class II, Zoledronic Acid Injection 5mg/100ml Ster..., Dr. Reddy's Laboratories, Inc. FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 021223 Orange Book
- First approved
- 08/20/2001 Orange Book
- Dosage forms
- injectable
- Routes
- intravenous
- Other brand names
- Reclast
- Status
- NDA 021223 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.