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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
McKinsey
Dow
Federal Trade Commission
Boehringer Ingelheim
Healthtrust
Moodys
Fish and Richardson
Merck
Deloitte

Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207925

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NDA 207925 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 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 NDA: 207925

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

Pharmacology for NDA: 207925

Mechanism of ActionChloride Channel Activation Potentiators
Cytochrome P450 3A4 Inhibitors
Cytochrome P450 2C9 Inhibitors
P-Glycoprotein Inhibitors
Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 207925

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KALYDECO
ivacaftor
 GRANULE;ORAL 207925 NDA Vertex Pharmaceuticals Incorporated 51167-300 51167-300-01 56 GRANULE in 1 CARTON (51167-300-01)
KALYDECO
ivacaftor
 GRANULE;ORAL 207925 NDA Vertex Pharmaceuticals Incorporated 51167-400 51167-400-01 56 GRANULE in 1 CARTON (51167-400-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength50MG/PACKET
Approval Date:Mar 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 21, 2017
Regulatory Exclusivity Use:
Patent:► SubscribePatent Expiration:May 20, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Aug 5, 2027Product Flag?Substance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

Colorcon
Julphar
Harvard Business School
Express Scripts
Moodys
Daiichi Sankyo
Dow
Merck
Argus Health
Cipla

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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