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Details for New Drug Application (NDA): 206038
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NDA 206038 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 nineteen 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.
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: | 19 |
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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