Last Updated: September 24, 2026

Details for Patent: 12,037,644


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Which drugs does patent 12,037,644 protect, and when does it expire?

Patent 12,037,644 protects BALVERSA and is included in one NDA.

This patent has sixty patent family members in thirty-nine countries.

Summary for Patent: 12,037,644
Title:Use of FGFR mutant gene panels in identifying cancer patients that will be responsive to treatment with an FGFR inhibitor
Abstract:Disclosed herein are methods of identifying a cancer patient that will be responsive to treatment with a fibroblast growth factor receptor (FGFR) inhibitor and methods of treating cancer patients. The methods involve evaluating a biological sample from the patient for the presence of one or more FGFR mutants from a FGFR mutant gene panel. Kits and primers for identifying the presence of one or more FGFR mutant genes in a biological sample are also disclosed herein.
Inventor(s):Suso Jesus PLATERO, Jayaprakash Karkera
Assignee: Janssen Pharmaceutica NV
Application Number:US16/136,201
Patent Claim Types:
see list of patent claims
Use;

Drugs Protected by US Patent 12,037,644

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-001 Apr 12, 2019 RX Yes No 12,037,644 ⤷  Start Trial TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS (Y373C IDENTIFIED) WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY ⤷  Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No 12,037,644 ⤷  Start Trial TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS (Y373C IDENTIFIED) WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY ⤷  Start Trial
Janssen Biotech BALVERSA erdafitinib TABLET;ORAL 212018-003 Apr 12, 2019 RX Yes Yes 12,037,644 ⤷  Start Trial TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS (Y373C IDENTIFIED) WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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