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Details for New Drug Application (NDA): 206038
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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 206038
Tradename: | ORKAMBI |
Applicant: | Vertex Pharms Inc |
Ingredient: | ivacaftor; lumacaftor |
Patents: | 17 |
Generic Entry Opportunity Date for 206038
Generic Entry Date for 206038*:
Constraining patent/regulatory exclusivity:
Dosage:
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.
Pharmacology for NDA: 206038
Suppliers and Packaging for NDA: 206038
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-700 | 51167-700-02 | 4 CARTON in 1 BOX (51167-700-02) > 7 BLISTER PACK in 1 CARTON > 4 TABLET, FILM COATED in 1 BLISTER PACK |
ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-809 | 51167-809-01 | 4 CARTON in 1 BOX (51167-809-01) > 7 BLISTER PACK in 1 CARTON > 4 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG;200MG | ||||
Approval Date: | Jul 2, 2015 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jan 25, 2021 | ||||||||
Regulatory Exclusivity Use: | ADDITIONAL INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS AGED 6 THROUGH 11 YEARS (TRIAL 4) | ||||||||
Regulatory Exclusivity Expiration: | Jul 2, 2020 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Sep 28, 2023 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE |
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