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 seven 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:	7

Pharmacology for NDA: 202811

Mechanism of Action	Guanylate 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	0456-1201-07	1 BOTTLE in 1 CARTON (0456-1201-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	145MCG
Approval Date:	Aug 30, 2012	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 4, 2028
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	May 4, 2029
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Jun 12, 2026
Regulatory Exclusivity Use:	TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE

Expired US Patents for NDA 202811

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012	8,080,526	⤷ Start Trial
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017	7,371,727	⤷ Start Trial
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012	7,745,409	⤷ Start Trial
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012	8,080,526	⤷ Start Trial
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012	7,704,947	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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