Details for New Drug Application (NDA): 203188
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NDA 203188 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 203188
| Tradename: | KALYDECO |
| Applicant: | Vertex Pharms |
| Ingredient: | ivacaftor |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203188
Generic Entry Date for 203188*:
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: 203188
Suppliers and Packaging for NDA: 203188
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KALYDECO | ivacaftor | TABLET;ORAL | 203188 | NDA | Vertex Pharmaceuticals Incorporated | 51167-200 | 51167-200-01 | 4 BLISTER PACK in 1 CARTON (51167-200-01) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
| KALYDECO | ivacaftor | TABLET;ORAL | 203188 | NDA | Vertex Pharmaceuticals Incorporated | 51167-200 | 51167-200-02 | 1 BOTTLE in 1 CARTON (51167-200-02) / 60 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 31, 2012 | 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: | 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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