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Last Updated: August 3, 2020

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Levoleucovorin calcium - Generic Drug Details

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What are the generic 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, Meitheal, 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. Seven suppliers are listed for this compound.

Recent Clinical Trials for levoleucovorin calcium

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

SponsorPhase
United States Department of DefensePhase 2
Autism SpeaksPhase 2
New York State Institute for Basic ResearchPhase 2

See all levoleucovorin calcium clinical trials

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
Mylan Teoranta LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 203576-001 Oct 20, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Meitheal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 211002-001 Aug 16, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 203563-001 Mar 9, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 207548-001 Sep 8, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 210892-001 Sep 14, 2018 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
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Baxter

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