Details for New Drug Application (NDA): 207925

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 fourteen 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:	14

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 207925

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.

Pharmacology for NDA: 207925

Mechanism of Action

Chloride Channel Activation Potentiators Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein 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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	50MG/PACKET
Approval Date:	Mar 17, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 22, 2028
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:	Dec 21, 2027
Regulatory Exclusivity Use:	FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
Regulatory Exclusivity Expiration:	Jun 21, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 207925

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-001	Mar 17, 2015
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-005	May 3, 2023
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-004	May 3, 2023
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-003	Apr 29, 2019
Vertex Pharms Inc	KALYDECO	ivacaftor	GRANULE;ORAL	207925-002	Mar 17, 2015

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