Drug facts
BrandLinzess (Linaclotide)
No generic linaclotide has an active Orange Book listing (a generic was first approved 02/09/2021); the latest Linzess patent or exclusivity in the Orange Book runs to 02/16/2034.
Linzess was first approved by the FDA on 08/30/2012 under NDA 202811; the application holder is Abbvie Inc.
The latest NADAC for LINZESS 72 MCG CAPSULE is $9.01 per unit (as of 10/28/2026).
Holder Abbvie IncApplication NDA 202811Approved 08/30/2012
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.
2,665days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved08/30/2012
Exclusivity ends05/21/2029
Last patent02/16/2034
201320172021202520292033
- Latest patent
- 02/16/2034Linzess Orange Book
- Exclusivity
- 05/21/2029Linzess Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- First generic approved
- 02/09/2021 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 Linzess profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $9.01 per unitLINZESS 72 MCG CAPSULE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Abbvie Inc Orange Book
- Application
- NDA 202811 Orange Book
- First approved
- 08/30/2012 Orange Book
- Dosage forms
- capsule
- 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.