DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 206038
NDA 206038 describes ORKAMBI, which is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are fifteen 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: | 15 |
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 | N | 51167-700-02 |
| ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-809 | N | 51167-809-01 |
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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