Drug facts
BrandAveed (Testosterone Undecanoate)
No generic testosterone undecanoate is approved; the latest Aveed patent or exclusivity in the Orange Book runs to 05/08/2027. 2 staged generic applications passed FDA review and wait on patents or exclusivity.
Aveed was first approved by the FDA on 03/05/2014 under NDA 022219; the application holder is Endo Operations Ltd.
The latest NADAC for TESTOSTERONE 12.5 MG/1.25 GRAM is $0.80 per gram (as of 10/28/2026).
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.
190days until the latest Aveed patent expires
- Latest patent
- 05/08/2027Aveed Orange Book
- Later patents, other products
- Tlando 04/28/2041; Kyzatrex 03/29/2041; Jatenzo 04/12/2039 Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 2 passed FDA review, awaiting market entry FDA
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.80 per gramTESTOSTERONE 12.5 MG/1.25 GRAM, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Endo Operations Ltd Orange Book
- Application
- NDA 022219 Orange Book
- First approved
- 03/05/2014 Orange Book
- Dosage forms
- injectable
- Routes
- intramuscular
- Other brand names
- JatenzoKyzatrexTlando
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.