Details for New Drug Application (NDA): 214622
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NDA 214622 describes TRUSELTIQ, which is a drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this drug. Additional details are available on the TRUSELTIQ profile page.
The generic ingredient in TRUSELTIQ is infigratinib phosphate. There is one drug master file entry for this compound. Additional details are available on the infigratinib phosphate profile page.
The generic ingredient in TRUSELTIQ is infigratinib phosphate. There is one drug master file entry for this compound. Additional details are available on the infigratinib phosphate profile page.
Summary for 214622
| Tradename: | TRUSELTIQ |
| Applicant: | Helsinn Hlthcare |
| Ingredient: | infigratinib phosphate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214622
Generic Entry Date for 214622*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | May 28, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | May 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 11, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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