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Last Updated: October 26, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210491


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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-one 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:21
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 210491
Generic Entry Date for 210491*:
Constraining patent/regulatory exclusivity:
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:RXDosage:TABLET;ORALStrength150MG;150MG, 100MG
Approval Date:Feb 12, 2018TE: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:Feb 12, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 21, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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