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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	D. Nev.	2014-06-18	Terminated 2016-06-09	—

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

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Lachman Consultant Services, Inc. FDA-2014-P-0637 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA Commissioner determine whether FUSILEV (levoleucovorin calcium) Injection, 175 mg/17.5 mL (Spectrum Pharmaceuticals, NDA 020140), approved April 29, 2011, was voluntarily withdrawn from sale for safet	505(q)	2014-05-22	Denied	Lachman Consultant Services, Inc.
Citizen Petition from Lachman Consultant Services Inc. FDA-2014-P-0315 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA Commissioner determine whether FUSILEV (levoleucovorin calcium) Injection, 250 mg/25 mL, approved under NDA 020140 by Spectrum Pharmaceuticals, was voluntarily withdrawn from sale for safety or effect	505(q)	2014-03-28	Denied	Lachman Consultant Services Inc.
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0821 · 4 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed a citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Levoleucovorin Calcium Injection, 10 mg/mL (50 mg/5 mL) suitable for submission as an ANDA. The petition seek	Other	2011-11-22	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30
Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium NCT04060017	Phase 2	Active	Southwest Autism Research & Resource Center	80	2020-09-22 → 2026-07-31
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)NCT04210115	Phase 3	Active	Merck Sharp & Dohme LLC	703	2020-02-28 → 2026-06-26
Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism NCT04060030	Phase 2	Recruiting	Southwest Autism Research & Resource Center	80	2020-10-08 → 2026-07-31
A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment NCT03428958	Phase 1/2	Completed	NuCana plc	111	2018-10-05 → 2024-03-21
Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach NCT01611857	Phase 1/2	Completed	SCRI Development Innovations, LLC	49	2012-07 → 2015-08
Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab NCT03698461	Phase 2	Completed	Asan Medical Center	20	2019-05-15 → 2023-10-24
Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer NCT01895257	Phase 3	UNKNOWN	Universiteit Antwerpen	162	2013-08 → 2018-12
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®NCT01820091	Phase 1	Withdrawn	Acrotech Biopharma Inc.	—	2013-04 → 2015-04
Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC NCT03222089	Phase 2	Withdrawn	Fujian Cancer Hospital	—	2017-07-20 → 2020-07-20

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

Medicare Part B Spending

CMS physician-administered drug spending for Fusilev (2024)

Total Spending

$119K

Total Claims

1,837

Beneficiaries

287

ASP Price

$0.09

Spending Trend

$1.4M(2020)→$424K(2021)→$553K(2022)→$1.1M(2023)→$119K(2024)

YoY Change:-80.6%

5yr CAGR:-16.2%

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

Source: CMS Medicare Part B Spending by Drug (2024). 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