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LEVOLEUCOVORIN CALCIUM

NDA

LEVOLEUCOVORIN CALCIUM | N208723 | ACTAVIS LLC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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.

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

2 letters from Drugs@FDA

Date	Submission	Document
Mar 24, 2017	SUPPL -2	View Letter (PDF)
Oct 3, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 175MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 29, 2016

No patent or exclusivity listings for this strength.