Details for New Drug Application (NDA): 214622
✉ Email this page to a colleague
The generic ingredient in TRUSELTIQ is infigratinib phosphate. 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: | ⤷ Sign Up | Patent Expiration: | Dec 11, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? |
Complete Access Available with Subscription