Drug facts
MoleculeMontelukast (Singulair)
Generics already compete: 19 makers on the market. 44 A-rated products from 19 makers substitute at the counter.
Singulair was first approved by the FDA on 02/20/1998 under NDA 020829; the application holder is Organon LLC A Sub of Organon and Co.
The latest NADAC for MONTELUKAST SOD 5 MG TAB CHEW is $0.07 per unit (as of 10/28/2026).
Holder Organon LLC A Sub of Organon and CoApplication NDA 020829Approved 02/20/1998
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 Singulair patent listed in the Orange Book Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- 08/03/2012 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 Montelukast profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.07 per unitMONTELUKAST SOD 5 MG TAB CHEW, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 10/13/2023Class II, Montelukast Sodium, Dr. Reddy's Laboratories, Inc. FDA enforcement
04Product
- Application holder
- Organon LLC A Sub of Organon and Co Orange Book
- Application
- NDA 020829 Orange Book
- First approved
- 02/20/1998 Orange Book
- Dosage forms
- granule; tablet; tablet, chewable
- 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.