Drug facts
MoleculePaclitaxel
Generics already compete: 13 makers on the market. 13 A-rated products from 13 makers substitute at the counter.
Taxol was first approved by the FDA on 12/29/1992 under NDA 020262; the application holder is Hq Specialty Pharma Corp. The Orange Book lists NDA 020262 as discontinued.
Holder Hq Specialty Pharma CorpApplication NDA 020262Approved 12/29/1992
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 Taxol patent listed in the Orange Book Orange Book
- Later patents, other products
- Abraxane 07/12/2034 Orange Book
02Competition
- Generics
- 13 generic makers Orange Book
- First generic approved
- 01/25/2002 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 Paclitaxel profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Hq Specialty Pharma Corp Orange Book
- Application
- NDA 020262 Orange Book
- First approved
- 12/29/1992 Orange Book
- Dosage forms
- injectable; powder
- Routes
- injection, intravenous
- Other brand names
- Abraxane
- Status
- NDA 020262 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.