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Last Updated: July 22, 2024

Details for New Drug Application (NDA): 202811


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NDA 202811 describes LINZESS, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LINZESS profile page.

The generic ingredient in LINZESS is linaclotide. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linaclotide profile page.
Summary for 202811
Tradename:LINZESS
Applicant:Abbvie
Ingredient:linaclotide
Patents:12
Formulation / Manufacturing:see details
Pharmacology for NDA: 202811
Mechanism of ActionGuanylate Cyclase Activators
Suppliers and Packaging for NDA: 202811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINZESS linaclotide CAPSULE;ORAL 202811 NDA Allergan, Inc. 0456-1201 0456-1201-04 1 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE
LINZESS linaclotide CAPSULE;ORAL 202811 NDA Allergan, Inc. 0456-1201 0456-1201-30 1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength145MCG
Approval Date:Aug 30, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 12, 2026
Regulatory Exclusivity Use:TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
Patent:⤷  Sign UpPatent Expiration:Aug 30, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Patent:⤷  Sign UpPatent Expiration:Aug 30, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS

Expired US Patents for NDA 202811

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 ⤷  Sign Up ⤷  Sign Up
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 ⤷  Sign Up ⤷  Sign Up
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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