Details for New Drug Application (NDA): 212273
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NDA 212273 describes TRIKAFTA (COPACKAGED), which is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are thirty-two patents protecting this drug. Additional details are available on the TRIKAFTA (COPACKAGED) profile page.
The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.
The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.
Summary for 212273
| Tradename: | TRIKAFTA (COPACKAGED) |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | elexacaftor, ivacaftor, tezacaftor; ivacaftor |
| Patents: | 28 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212273
*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.
Suppliers and Packaging for NDA: 212273
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | TABLET;ORAL | 212273 | NDA | Vertex Pharmaceuticals Incorporated | 51167-106 | 51167-106-02 | 4 BLISTER PACK in 1 CARTON (51167-106-02) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-206-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-306-07) |
| TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | TABLET;ORAL | 212273 | NDA | Vertex Pharmaceuticals Incorporated | 51167-331 | 51167-331-01 | 4 BLISTER PACK in 1 CARTON (51167-331-01) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-431-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-531-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG,75MG,50MG; 150MG | ||||
| Approval Date: | Oct 21, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 8, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA | ||||||||
| Regulatory Exclusivity Expiration: | Oct 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE | ||||||||
| Regulatory Exclusivity Expiration: | Oct 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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