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Generated: November 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202811

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NDA 202811 describes LINZESS, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. There are ten 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. Two suppliers are listed for this compound. Additional details are available on the linaclotide profile page.
Summary for 202811
Tradename:LINZESS
Applicant:Allergan Sales Llc
Ingredient:linaclotide
Patents:10
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 202811
Generic Entry Date for 202811*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
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
Patent:➤ Sign UpPatent Expiration:Jan 28, 2024Product Flag?Substance Flag?YDelist Request?

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