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FDA Orange Book · active-ingredient family

Larotrectinib sulfate

Larotrectinib sulfate: 2 brands, 0 generics; first approved Nov 26, 2018; on patent until Oct 21, 2029.

On patent
Generic status & protection

Protected until Oct 21, 2029 (earliest listed patent expiry).

Earliest patent expiry Oct 21, 2029
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
20
Next patent expiry
Oct 21, 2029
in 3 yr 4 mo
Originator applications

Brand (NDA) products

VITRAKVIRLD
NDA 21086120182 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 25MG BASECAPSULEORALRx—
EQ 100MG BASECAPSULEORALRx—
VITRAKVIRLDRS
NDA 2117102018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 20MG BASE/MLSOLUTIONORALRx—
Protection horizon

Patent & exclusivity timeline

2026202820302032203420362038TodayPatent 10047097 — 2029-10-21Patent 10047097Patent 8865698 — 2029-10-21Patent 8865698Patent 10005783 — 2029-10-21Patent 10005783Patent 9447104 — 2029-10-21Patent 9447104Patent 9676783 — 2029-10-21Patent 9676783Patent 10774085 — 2029-10-21Patent 10774085Patent 9127013 — 2029-10-21Patent 9127013Patent 8513263 — 2029-12-23Patent 8513263Patent 9782414 — 2035-11-16Patent 9782414Patent 10285993 — 2035-11-16Patent 10285993Patent 10813936 — 2035-11-16Patent 10813936Patent 10172861 — 2035-11-16Patent 10172861Patent 10799505 — 2036-08-15Patent 10799505Patent 10045991 — 2037-04-04Patent 10045991Patent 11484535 — 2037-04-04Patent 11484535Patent 11191766 — 2037-04-04Patent 11191766Patent 10668072 — 2037-04-04Patent 10668072Patent 10137127 — 2037-04-04Patent 10137127Patent 11974998 — 2037-05-16Patent 11974998Patent 11337967 — 2037-05-16Patent 11337967
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10047097Oct 21, 2029in 3 yr 4 mo
U-2474
8865698Oct 21, 2029in 3 yr 4 mo
U-2469
10005783Oct 21, 2029in 3 yr 4 mo
U-2472
9447104Oct 21, 2029in 3 yr 4 mo
U-2470
9676783Oct 21, 2029in 3 yr 4 mo
U-2469
10774085Oct 21, 2029in 3 yr 4 mo
U-2470
9127013Oct 21, 2029in 3 yr 4 mo
SubstanceProduct
8513263Dec 23, 2029in 3 yr 6 mo
SubstanceProduct
9782414Nov 16, 2035in 9 yr 6 mo
U-2475
10285993Nov 16, 2035in 9 yr 6 mo
U-2470
10813936Nov 16, 2035in 9 yr 6 mo
U-2987
10172861Nov 16, 2035in 9 yr 6 mo
SubstanceProduct
10799505Aug 15, 2036in 10 yr 3 mo
SubstanceProduct
10045991Apr 04, 2037in 10 yr 11 mo
U-2473
11484535Apr 04, 2037in 10 yr 11 mo
U-2470
11191766Apr 04, 2037in 10 yr 11 mo
U-2471
10668072Apr 04, 2037in 10 yr 11 mo
Product
10137127Apr 04, 2037in 10 yr 11 mo
Product
11974998May 16, 2037in 11 yr
U-4124
11337967May 16, 2037in 11 yr
U-4123
FDA approval span

Approval history

First approval
Nov 26, 2018
7 yr 9 mo ago
Most recent approval
Nov 26, 2018
7 yr 9 mo ago

All 2 applications were approved in 2018.

Brand (NDA) 2100%
Generic (ANDA) 00%

Larotrectinib sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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