BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
US Army

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207925

« Back to Dashboard

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 207925
Applicant:Vertex Pharms Inc
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)

Profile 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:
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 31, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Queensland Health
Boehringer Ingelheim
Chinese Patent Office

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.