Details for New Drug Application (NDA): 211358

NDA 211358 describes ORKAMBI, which is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the ORKAMBI profile page.

The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.

Summary for 211358

Tradename:	ORKAMBI
Applicant:	Vertex Pharms Inc
Ingredient:	ivacaftor; lumacaftor
Patents:	20

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211358

Constraining patent/regulatory exclusivity:

8,993,600

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: 211358

Mechanism of Action

Chloride Channel Activation Potentiators Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors P-Glycoprotein Inducers P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 211358

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358	NDA	Vertex Pharmaceuticals Incorporated	51167-122	51167-122-01	56 PACKET in 1 CARTON (51167-122-01) / 1 GRANULE in 1 PACKET
ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358	NDA	Vertex Pharmaceuticals Incorporated	51167-500	51167-500-02	56 PACKET in 1 CARTON (51167-500-02) / 1 GRANULE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	125MG/PACKET;100MG/PACKET
Approval Date:	Aug 7, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 7, 2025
Regulatory Exclusivity Use:	FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
Regulatory Exclusivity Expiration:	Sep 2, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Sep 2, 2029
Regulatory Exclusivity Use:	TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE

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