Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

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 nineteen 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:19
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, 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, 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, TABLET;ORALStrength150MG,N/A;150MG, 100MG
Approval Date:Feb 12, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 12, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 21, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 12, 2025
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR

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