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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Generated: August 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211358

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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 seventeen 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:16
Generic Entry Opportunity Date for 211358
Generic Entry Date for 211358*:
Constraining patent/regulatory exclusivity:
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.

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 51167-500 51167-500-02 56 PACKET in 1 CARTON (51167-500-02) > 1 GRANULE in 1 PACKET
ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358 NDA Vertex Pharmaceuticals Incorporated 51167-900 51167-900-01 56 PACKET in 1 CARTON (51167-900-01) > 1 GRANULE in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength125MG/PACKET;100MG/PACKET
Approval Date:Aug 7, 2018TE: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:Jul 2, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 7, 2021
Regulatory Exclusivity Use:NEW PRODUCT

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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 verifification 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.