Drug facts
MoleculeCephalexin
Generics already compete: 8 makers on the market. 32 A-rated products from 8 makers substitute at the counter.
Keflet was first approved by the FDA before 1982 under NDA 050440; the application holder is Eli Lilly and Co. The Orange Book lists NDA 050440 as discontinued.
The latest NADAC for CEPHALEXIN 500 MG CAPSULE is $0.12 per unit (as of 10/28/2026).
Holder Eli Lilly and CoApplication NDA 050440Approved 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 Keflet patent listed in the Orange Book Orange Book
02Competition
- Generics
- 8 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 Cephalexin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.12 per unitCEPHALEXIN 500 MG CAPSULE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 05/23/2025Class II, Cephalexin for Oral Suspension, Ascend Laboratories, LLC FDA enforcement
04Product
- Application holder
- Eli Lilly and Co Orange Book
- Application
- NDA 050440 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule; for suspension; tablet
- Routes
- oral
- Status
- NDA 050440 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.