Viewing data from:

LINZESS

NDA

LINACLOTIDE | N202811 | ABBVIE INC

3 strengths7 unique patents3 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (6)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

Feb. 28, 2027

Apr. 30, 2032

Apr. 30, 2032

Aug. 17, 2031

Feb. 16, 2034

Feb. 11, 2032

Feb. 11, 2032

I-921

May. 4, 2029

NPP

May. 4, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Forest Laboratories, LLC et al v. Mylan Pharmaceuticals Inc. 1:2017cv01728 10 patentsANDA 209564linaclotide	D. Del.	2017-11-30	Terminated 2018-08-30	—
Forest Laboratories, LLC et al v. Teva Pharmaceuticals USA, Inc. 1:2017cv01481 10 patentsANDA 209568linaclotide	D. Del.	2017-10-20	Terminated 2018-05-14	—
Allergan Sales, LLC et al v. Teva Pharmaceuticals USA, Inc. et al 1:2016cv01114 8 patentsANDA 211381linaclotide	D. Del.	2016-11-30	Terminated 2020-01-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer NCT03796884	Phase 2	Active	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	150	2019-10-30 → 2026-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Linzess (2023)

Total Spending

$1.8B

Total Claims

2,263,018

Beneficiaries

565,088

Avg Cost/Unit

$18.14

Spending Trend

$983.9M(2019)→$1.1B(2020)→$1.4B(2021)→$1.6B(2022)→$1.8B(2023)

YoY Change:+5.8%

5yr CAGR:+5.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs2 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

CORDEN PHARMA COLORADO INCLINACLOTIDE

DMF 249922011

POLYPEPTIDE LABORATORIES SWEDEN ABLINACLOTIDE DRUG SUBSTANCE

DMF 250212011

POLYPEPTIDE LABORATORIES INCLINACLOTIDE DRUG SUBSTANCE

DMF 250252011

AURO PEPTIDES LTDLINACLOTIDE

DMF 297082015

SUN PHARMACEUTICAL INDUSTRIES LTDLINACLOTIDE

DMF 302662016

TAPI NL BVLINACLOTIDE

DMF 302742016

MSN LIFE SCIENCES PRIVATE LTDLINACLOTIDE

DMF 313512017

HYBIO PHARMACEUTICAL CO LTDLINACLOTIDE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 323142017

CHENGDU SHENGNUO BIOPHARM CO LTDLINACLOTIDE

DMF 358122021

HYBIO PHARMACEUTICAL CO LTDLINACLOTIDE NON-STERILE DRUG SUBSTANCE

DMF 373702022

HANGZHOU THINHEAL PHARMA-TECH CO LTDLINACLOTIDE

DMF 399012024

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDLINACLOTIDE

DMF 420402025

ZHEJIANG PEPTITES BIOTECH CO LTDLINACLOTIDE

DMF 420492025

SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTDLINACLOTIDE

DMF 426352025

BACHEM AMERICAS INCInactiveLINACLOTIDE (BULK)

DMF 282732014

MSN LIFE SCIENCES PRIVATE LTDInactiveLINACLOTIDE [ROUTE CODE LE]

DMF 304212016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
May 26, 2026	SUPPL -23	View Letter (PDF)
Nov 5, 2025	SUPPL -22	View Letter (PDF)
Jun 13, 2023	SUPPL -21	View Letter (PDF)
Aug 26, 2021	SUPPL -18	View Letter (PDF)
Apr 13, 2021	SUPPL -17	View Letter (PDF)
Sep 23, 2020	SUPPL -16	View Letter (PDF)
Mar 14, 2017	SUPPL -13	View Letter (PDF)
Jan 27, 2017	SUPPL -10	View Letter (PDF)
Aug 31, 2016	SUPPL -11	View Letter (PDF)
Apr 8, 2016	SUPPL -7	View Letter (PDF)
Nov 24, 2015	SUPPL -9	View Letter (PDF)
Jul 10, 2014	SUPPL -4	View Letter (PDF)
Aug 12, 2013	SUPPL -3	View Letter (PDF)
Aug 31, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 145MCG

RLD

5 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Aug 30, 2012

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7304036	Aug 30, 2026PED: Feb 28, 2027	PED	Yes	Yes		—
8748573	Oct 30, 2031PED: Apr 30, 2032	PED	—	—		—
8802628	Oct 30, 2031PED: Apr 30, 2032	PED	—	Yes	—	—
8933030	Feb 17, 2031PED: Aug 17, 2031	PED	—	Yes		—
9708371	Aug 16, 2033PED: Feb 16, 2034	PED	—	Yes		—

Exclusivities (3)

Code	Date	Status
I-921	Jun 12, 2026	Expired
NPP	Nov 4, 2028	Active
PED	May 4, 2029	Active

#002 — 290MCG

RLD

5 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 30, 2012

#003 — 72MCG

RLD

5 patents1 exclusivity▾

CAPSULE;ORAL | Approved: Jan 25, 2017