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Generated: May 22, 2017

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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 six patents protecting this drug. Additional details are available on the KALYDECO profile page.

The generic ingredient in KALYDECO is ivacaftor. There are two 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 NDA: 203188


Suppliers and Packaging for NDA: 203188

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 203188 NDA Vertex Pharmaceuticals Incorporated 51167-200 51167-200-01 4 BLISTER PACK in 1 CARTON (51167-200-01) > 14 TABLET, FILM COATED in 1 BLISTER PACK
TABLET;ORAL 203188 NDA Vertex Pharmaceuticals Incorporated 51167-200 51167-200-02 1 BOTTLE in 1 CARTON (51167-200-02) > 60 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 31, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 21, 2017
Regulatory Exclusivity Use:
Patent:7,495,103Patent Expiration:May 20, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,324,242Patent Expiration:Aug 5, 2027Product Flag?Substance Flag?Delist Request?

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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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