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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Medtronic
Citi
Cantor Fitzgerald
Queensland Health
Teva
McKesson
Dow
Healthtrust

Generated: July 16, 2018

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 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 207925
Tradename:KALYDECO
Applicant:Vertex Pharms Inc
Ingredient:ivacaftor
Patents:8
Generic Entry Opportunity Date for 207925
Generic Entry Date for 207925*:
Constraining patent/regulatory exclusivity:
Dosage::
GRANULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 N 51167-300-01
KALYDECO ivacaftor GRANULE;ORAL 207925 NDA Vertex Pharmaceuticals Incorporated 51167-400 N 51167-400-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength50MG/PACKET
Approval Date:Mar 17, 2015TE: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:

Merck
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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.