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Last Updated: October 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212273

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NDA 212273 describes TRIKAFTA (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 TRIKAFTA (COPACKAGED) profile page.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.
Summary for 212273
Generic Entry Opportunity Date for 212273
Generic Entry Date for 212273*:
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: 212273
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET, TABLET;ORAL 212273 NDA Vertex Pharmaceuticals Incorporated 51167-331 51167-331-01 4 BLISTER PACK in 1 CARTON (51167-331-01) > 1 KIT in 1 BLISTER PACK * 14 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;ORALStrength100MG,75MG,50MG;N/A,150MG,N/A
Approval Date:Oct 21, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 21, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Regulatory Exclusivity Expiration:Feb 12, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 21, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.