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Details for New Drug Application (NDA): 207925
NDA 207925 describes KALYDECO, which is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KALYDECO profile page.
The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
The generic ingredient in KALYDECO is ivacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor profile page.
Summary for 207925
| Tradename: | KALYDECO |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | ivacaftor |
| Patents: | 8 |
Generic Entry Opportunity Date for 207925
*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: 207925
Suppliers and Packaging for NDA: 207925
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-300 | 51167-300-01 | 56 GRANULE in 1 CARTON (51167-300-01) |
| KALYDECO | ivacaftor | GRANULE;ORAL | 207925 | NDA | Vertex Pharmaceuticals Incorporated | 51167-400 | 51167-400-01 | 56 GRANULE in 1 CARTON (51167-400-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 50MG/PACKET | ||||
| Approval Date: | Mar 17, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 31, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 15, 2025 | ||||||||
| Regulatory Exclusivity Use: | THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA | ||||||||
| Regulatory Exclusivity Expiration: | Jul 31, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T | ||||||||
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