Drug facts
MoleculeAmitriptyline
Generics already compete: 11 makers on the market. 66 A-rated products from 11 makers substitute at the counter.
Elavil was first approved by the FDA before 1982 under NDA 012703; the application holder is Astrazeneca Pharmaceuticals LP. The Orange Book lists NDA 012703 as discontinued.
The latest NADAC for AMITRIPTYLINE HCL 50 MG TAB is $0.10 per unit (as of 10/28/2026).
Holder Astrazeneca Pharmaceuticals LPApplication NDA 012703Approved 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 Elavil patent listed in the Orange Book Orange Book
02Competition
- Generics
- 11 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 Amitriptyline profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.10 per unitAMITRIPTYLINE HCL 50 MG TAB, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Astrazeneca Pharmaceuticals LP Orange Book
- Application
- NDA 012703 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Status
- NDA 012703 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.