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Serving leading biopharmaceutical companies globally:

Novartis
Baxter
Fuji
AstraZeneca
Dow
Merck
Covington
Chubb
UBS
Deloitte

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202811

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NDA 202811 describes LINZESS, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from three 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 nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linaclotide profile page.

Summary for NDA: 202811

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:10
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength145MCG
Approval Date:Aug 30, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 30, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Aug 30, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Patent:► SubscribePatent Expiration:Aug 30, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS


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Serving leading biopharmaceutical companies globally:

Dow
Fuji
Covington
Harvard Business School
Chinese Patent Office
Cipla
Teva
QuintilesIMS
Daiichi Sankyo
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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