Drug facts
MoleculeAmoxicillin (Amoxil)
Generics already compete: 7 makers on the market. 43 A-rated products from 7 makers substitute at the counter.
Amoxil was first approved by the FDA before 1982 under NDA 050459; the application holder is Glaxosmithkline. The Orange Book lists NDA 050459 as discontinued.
The latest NADAC for AMOXICILLIN 250 MG/5 ML SUSP is $0.02 per mL (as of 10/28/2026).
Holder GlaxosmithklineApplication NDA 050459Approved 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 Amoxil patent listed in the Orange Book Orange Book
- Later patents, other products
- Moxatag 05/07/2027 Orange Book
02Competition
- Generics
- 7 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 Amoxicillin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.02 per mLAMOXICILLIN 250 MG/5 ML SUSP, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 04/13/2022Class II, Amoxicillin, Mckesson Medical-Surgical Inc. Corporate Office FDA enforcement
04Product
- Application holder
- Glaxosmithkline Orange Book
- Application
- NDA 050459 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule; for suspension; tablet; tablet, chewable
- Routes
- oral
- Other brand names
- Larotid
- Status
- NDA 050459 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.