Details for New Drug Application (NDA): 210491
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NDA 210491 describes SYMDEKO (COPACKAGED), which is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are twenty-five patents protecting this drug. Additional details are available on the SYMDEKO (COPACKAGED) profile page.
The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.
The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.
Summary for 210491
| Tradename: | SYMDEKO (COPACKAGED) |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | ivacaftor; ivacaftor, tezacaftor |
| Patents: | 25 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210491
*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: 210491
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET;ORAL | 210491 | NDA | Vertex Pharmaceuticals Incorporated | 51167-113 | 51167-113-01 | 1 KIT in 1 CARTON (51167-113-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK |
| SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET;ORAL | 210491 | NDA | Vertex Pharmaceuticals Incorporated | 51167-661 | 51167-661-01 | 1 KIT in 1 CARTON (51167-661-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;150MG, 100MG | ||||
| Approval Date: | Feb 12, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 21, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020 | ||||||||
| Regulatory Exclusivity Expiration: | Feb 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR | ||||||||
| Regulatory Exclusivity Expiration: | Jun 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO | ||||||||
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