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 twenty-two 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 211358
| Tradename: | ORKAMBI |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | ivacaftor; lumacaftor |
| Patents: | 20 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for NDA: 211358
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 | 51167-122 | 51167-122-01 | 56 PACKET in 1 CARTON (51167-122-01) / 1 GRANULE in 1 PACKET |
| 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 125MG/PACKET;100MG/PACKET | ||||
| Approval Date: | Aug 7, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| 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: | Sep 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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