Drug facts

Molecule

Alendronate (Fosamax)

Generics already compete: 9 makers on the market. 26 A-rated products from 9 makers substitute at the counter.

Fosamax was first approved by the FDA on 09/29/1995 under NDA 020560; the application holder is Organon LLC A Sub of Organon and Co.

The latest NADAC for ALENDRONATE SODIUM 70 MG TAB is $0.26 per unit (as of 10/28/2026).

Holder Organon LLC A Sub of Organon and CoApplication NDA 020560Approved 09/29/1995

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 Fosamax patent listed in the Orange Book
Orange Book
Later patents, other products
Binosto 12/05/2031
Orange Book

02Competition

Generics
9 generic makers
Orange Book
First generic approved
02/06/2008
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 Alendronate profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.26 per unitALENDRONATE SODIUM 70 MG TAB, mid-priced of 3 strengths, as of 10/28/2026
CMS NADAC
Latest recall
04/07/2026Class II, Alendronate Sodium, Hikma Pharmaceuticals USA Inc
FDA enforcement

04Product

Application holder
Organon LLC A Sub of Organon and Co
Orange Book
Application
NDA 020560
Orange Book
First approved
09/29/1995
Orange Book
Dosage forms
solution; tablet
Routes
oral

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.