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Last Updated: December 8, 2019

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Levoleucovorin calcium - Generic Drug Details

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What are the generic drug sources for levoleucovorin calcium and what is the scope of patent protection?

Levoleucovorin calcium is the generic ingredient in two branded drugs marketed by Acrotech, Actavis Llc, Amneal Pharms Co, Nanjing King-friend, West-ward Pharms Int, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Teoranta, and Sandoz Inc, and is included in twelve NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levoleucovorin calcium has twenty-one patent family members in nine countries.

There is one drug master file entry for levoleucovorin calcium. Eleven suppliers are listed for this compound.

Recent Clinical Trials for levoleucovorin calcium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ArizonaPhase 2
State University of New York - Downstate Medical CenterPhase 2
Phoenix Children's HospitalPhase 2

See all levoleucovorin calcium clinical trials

Recent Litigation for levoleucovorin calcium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Spectrum Pharmaceuticals, Inc v. Sandoz Inc.2015-03-03
Spectrum Pharmaceuticals, Inc. v. Eurohealth International Sarl2014-06-18
Spectrum Pharmaceuticals Inc v. InnoPharma Inc.2012-03-02

See all levoleucovorin calcium litigation

Pharmacology for levoleucovorin calcium
Drug ClassFolate Analog
Medical Subject Heading (MeSH) Categories for levoleucovorin calcium
Paragraph IV (Patent) Challenges for LEVOLEUCOVORIN CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
FUSILEV SOLUTION;INTRAVENOUS levoleucovorin calcium 020140 2013-12-19
FUSILEV POWDER;INTRAVENOUS levoleucovorin calcium 020140 2013-12-19
FUSILEV POWDER;INTRAVENOUS levoleucovorin calcium 020140 2011-10-26
FUSILEV SOLUTION;INTRAVENOUS levoleucovorin calcium 020140 2011-10-26

US Patents and Regulatory Information for levoleucovorin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 206263-001 Jun 16, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 206516-001 Feb 13, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Teoranta LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 203576-002 Oct 20, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 208723-001 Sep 29, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Nanjing King-friend LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 211002-002 Aug 16, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 207548-001 Sep 8, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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