Viewing data from:

FUSILEV

NDA

LEVOLEUCOVORIN CALCIUM | N020140 | ACROTECH BIOPHARMA INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Spectrum Pharmaceuticals, Inc. et al v. Eurohealth International Sarl, et al 2:2014cv00980 1 patentANDA 206263levoleucovorin	NVD	2014-06-18	Terminated 2016-06-09	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Placebo-controlled Trial of Folinic Acid in Children With ASD NCT07642661	Phase 2	Recruiting	Prof. Adi Aran	150	2026-06-23 → 2027-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Fusilev (2023)

Total Spending

$1.1M

Total Claims

3,223

Beneficiaries

522

ASP Price

—

HCPCS: J0641 — Injection, levoleucovorin, not otherwise specified, 0.5 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain1 active DMF

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

GMT FINE CHEMICALS SALEVOLEUCOVORIN CALCIUM

DMF 251982011

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2020	SUPPL -26	View Letter (PDF)
Feb 5, 2020	SUPPL -25	View Letter (PDF)
Jan 9, 2020	SUPPL -24	View Letter (PDF)
May 4, 2011	SUPPL -2	View Letter (PDF)
Jul 15, 2008	SUPPL -1	View Letter (PDF)
Mar 12, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Mar 7, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 29, 2011

#003 — EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 29, 2011