Case	Court	Filed	Status	Judge
BOW RIVER LLC v. ZYDUS LIFESCIENCES GLOBAL FZE et al 2:2026cv05216 2 patentsANDA 220875larotrectinib	D.N.J.	2026-05-08	Active	—
Array BioPharma Inc. et al v. Zydus Lifesciences Ltd. et al 1:2026cv00541 5 patentsANDA 220875larotrectinib sulfate	D. Del.	2026-05-08	Active	—
Bow River LLC v. Zydus Lifesciences Global FZE et al 1:2026cv00535 2 patentsANDA 220875larotrectinib	D. Del.	2026-05-07	Active	—
Array BioPharma Inc. et al v. Alembic Pharmaceuticals Limited et al 1:2025cv01016 5 patentsANDA 220639larotrectinib sulfate	D. Del.	2025-08-13	Active	—
Bow River LLC v. Alembic Pharmaceuticals Limited et al 1:2025cv01017 2 patentsANDA 220639larotrectinib	D. Del.	2025-08-13	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Vitrakvi (2023)

Total Spending

$29.5M

Total Claims

804

Beneficiaries

144

Avg Cost/Unit

$548.12

Spending Trend

$7.4M(2020)→$17.4M(2021)→$22.0M(2022)→$29.5M(2023)

YoY Change:+13.2%

5yr CAGR:-0.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALEMBIC PHARMACEUTICALS LTDLAROTRECTINIB SULFATE

DMF 367852022

OLON SPALAROTRECTINIB SULFATE

DMF 370662022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG BASE

RLD

15 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 26, 2018

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8513263	Dec 23, 2029	—	Yes	Yes	—	—
8865698	Oct 21, 2029	—	—	—		—
9127013	Oct 21, 2029	—	Yes	Yes	—	—
9447104	Oct 21, 2029	—	—	—		—
9676783	Oct 21, 2029	—	—	—		—
9782414	Nov 16, 2035	—	—	—		—
10005783	Oct 21, 2029	—	—	—		—
10047097	Oct 21, 2029	—	—	—		—
10172861	Nov 16, 2035	—	Yes	Yes	—	—
10285993	Nov 16, 2035	—	—	—		—
10774085	Oct 21, 2029	—	—	—		—
10799505	Aug 15, 2036	—	Yes	Yes	—	—
10813936	Nov 16, 2035	—	—	—		—
11337967	May 16, 2037	—	—	—		—
11974998	May 16, 2037	—	—	—		—

#002 — EQ 100MG BASE

RLD

15 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 26, 2018