cliffwatch

erdafitinib · Janssen Biotech · NDA 212018

Balversa

Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Feb 2038

Blocked by patent: US 11077106, US 11077106. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 18 unexpired

PatentClaimsExpires
US 11077106use U-38082 Feb 2038
US 11077106use U-31962 Feb 2038
US 10478494use U-390213 Aug 2036
US 12678498use U-458413 Jun 2036
US 10898482product, use U-30669 Feb 2036
US 10898482product, use U-38079 Feb 2036
US 10898482product, use U-38069 Feb 2036
US 10898482product, use U-38059 Feb 2036
US 10898482product, use U-30659 Feb 2036
US 10898482product, use U-30679 Feb 2036
US 10898482product, use U-25189 Feb 2036
US 11684620use U-38059 Feb 2036
US 11684620use U-38079 Feb 2036
US 11684620use U-38069 Feb 2036
US 12037644use U-397218 Oct 2035
US 9902714product26 Mar 2035
US 8895601substance, product12 Apr 2033
US 9464071use U-380528 Apr 2031

Exclusivities · 1 unexpired

I-930new indication (3 years)19 Jan 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 25 Oct 2026Generic tentatively approved · 212018-001
  • 24 Oct 2026Exclusivity expires within 90 days I-930 · 212018-003
  • 24 Oct 2026Exclusivity expires within 90 days I-930 · 212018-002
  • 24 Oct 2026Exclusivity expires within 90 days I-930 · 212018-001

Products covered · 3

NDA · productFormStrengthListed expiry
212018 · 001 · RLDtablet, oral3MG2 Feb 2038
212018 · 002 · RLDtablet, oral4MG2 Feb 2038
212018 · 003 · RLDtablet, oral5MG2 Feb 2038