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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Express Scripts
Argus Health
Daiichi Sankyo
Healthtrust
US Army
AstraZeneca
Fuji
Cipla

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203188

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NDA 203188 describes KALYDECO, which is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KALYDECO profile page.

The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
Summary for 203188
Tradename:KALYDECO
Applicant:Vertex Pharms
Ingredient:ivacaftor
Patents:7
Suppliers and Packaging for NDA: 203188
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KALYDECO ivacaftor TABLET;ORAL 203188 NDA Vertex Pharmaceuticals Incorporated 51167-200 N 51167-200-01
KALYDECO ivacaftor TABLET;ORAL 203188 NDA Vertex Pharmaceuticals Incorporated 51167-200 N 51167-200-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 31, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 31, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 31, 2019
Regulatory Exclusivity Use:TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A G551D MUTATION IN THE CFTR GENE.
Patent:➤ Try a Free TrialPatent Expiration:May 20, 2027Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
AstraZeneca
Citi
Cantor Fitzgerald
Farmers Insurance
Healthtrust
Mallinckrodt
Medtronic
Merck

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