cliffwatch

larotrectinib sulfate · Bayer Hlthcare · NDA 210861, 211710

Vitrakvi

Earliest generic entry, as listed · earliest of 3 marketed strengths
16 May 2037

Blocked by patent: US 11337967, US 11974998. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 21 unexpired

PatentClaimsExpires
US 11337967use U-412316 May 2037
US 11974998use U-412416 May 2037
US 10045991use U-24734 Apr 2037
US 10137127product4 Apr 2037
US 10668072product4 Apr 2037
US 11191766use U-24714 Apr 2037
US 11484535use U-24704 Apr 2037
US 10799505substance, product15 Aug 2036
US 10172861substance, product16 Nov 2035
US 10285993use U-247016 Nov 2035
US 10813936use U-298716 Nov 2035
US 9782414use U-247516 Nov 2035
US 9782414use U-247116 Nov 2035
US 8513263substance, product23 Dec 2029
US 10005783use U-247221 Oct 2029
US 10047097use U-247421 Oct 2029
US 10774085use U-247021 Oct 2029
US 8865698use U-246921 Oct 2029
US 9127013substance, product21 Oct 2029
US 9447104use U-247021 Oct 2029
US 9676783use U-246921 Oct 2029

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 3

NDA · productFormStrengthListed expiry
210861 · 001 · RLDcapsule, oralEQ 25MG BASE16 May 2037
210861 · 002 · RLDcapsule, oralEQ 100MG BASE16 May 2037
211710 · 001 · RLDsolution, oralEQ 20MG BASE/ML16 May 2037