Details for New Drug Application (NDA): 217660
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NDA 217660 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-five 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 217660
| Tradename: | TRIKAFTA (COPACKAGED) |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | elexacaftor, ivacaftor, tezacaftor; ivacaftor |
| Patents: | 34 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217660
Generic Entry Date for 217660*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULES;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.
Suppliers and Packaging for NDA: 217660
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660 | NDA | Vertex Pharmaceuticals Incorporated | 51167-445 | 51167-445-01 | 4 PACKAGE in 1 CARTON (51167-445-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-545-07) * 1 GRANULE in 1 PACKET (51167-645-07) |
| TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660 | NDA | Vertex Pharmaceuticals Incorporated | 51167-446 | 51167-446-01 | 4 PACKAGE in 1 CARTON (51167-446-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-746-07) * 1 GRANULE in 1 PACKET (51167-846-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULES;ORAL | Strength | 80MG, 60MG, 40MG;59.5MG | ||||
| Approval Date: | Apr 26, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 20, 2027 | ||||||||
| Regulatory Exclusivity Use: | LABELING CHANGES BASED UPON RESULTS FROM STUDY 124 (TRIAL 5) | ||||||||
| Regulatory Exclusivity Expiration: | Apr 26, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Dec 20, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON CLINICAL AND/OR IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 20,2024 | ||||||||
Expired US Patents for NDA 217660
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660-001 | Apr 26, 2023 | ⤷ Get Started Free | ⤷ Get Started Free |
| Vertex Pharms Inc | TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor; ivacaftor | GRANULES;ORAL | 217660-002 | Apr 26, 2023 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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