Generated: December 15, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203188
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, 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 seven 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
Pharmacology for NDA: 203188
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Summary for product number 001
|Approval Date:||Jan 31, 2012||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Feb 21, 2017
|Regulatory Exclusivity Use:|
|Regulatory Exclusivity Expiration:||Jan 31, 2017
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Jul 31, 2020
|Regulatory Exclusivity Use:||NEW PATIENT POPULATION|
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