Details for New Drug Application (NDA): 207925
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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 thirteen 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: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207925
Generic Entry Date for 207925*:
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: 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: | Dec 21, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020 | ||||||||
| Regulatory Exclusivity Expiration: | May 3, 2030 | ||||||||
| Regulatory Exclusivity Use: | THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 1 MONTH TO LESS THAN 4 MONTHS OF AGE WHO HAVE AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA | ||||||||
| 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 | ||||||||
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