Details for New Drug Application (NDA): 210491

NDA 210491 describes SYMDEKO (COPACKAGED), which is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are twenty-six patents protecting this drug. Additional details are available on the SYMDEKO (COPACKAGED) profile page.

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

Summary for 210491

Tradename:	SYMDEKO (COPACKAGED)
Applicant:	Vertex Pharms Inc
Ingredient:	ivacaftor; ivacaftor, tezacaftor
Patents:	26

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210491

Dosage:

TABLET, TABLET;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: 210491

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491	NDA	Vertex Pharmaceuticals Incorporated	51167-113	51167-113-01	1 KIT in 1 CARTON (51167-113-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK
SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491	NDA	Vertex Pharmaceuticals Incorporated	51167-661	51167-661-01	1 KIT in 1 CARTON (51167-661-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG;150MG, 100MG
Approval Date:	Feb 12, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 21, 2027
Regulatory Exclusivity Use:	FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
Regulatory Exclusivity Expiration:	Jun 21, 2026
Regulatory Exclusivity Use:	TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO
Patent:		Patent Expiration:	Apr 9, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR

Expired US Patents for NDA 210491

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018

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