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Last Updated: June 28, 2022

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, Hikma, Meitheal, Gland Pharma Ltd, Mylan Teoranta, Novast Labs, Praxgen, and Sandoz Inc, and is included in thirteen 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. Six suppliers are listed for this compound.

Summary for levoleucovorin calcium
Recent Clinical Trials for levoleucovorin calcium

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

SponsorPhase
Autism SpeaksPhase 2
State University of New York - Downstate Medical CenterPhase 2
University of ArizonaPhase 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 Strength NDA ANDAs Submitted Submissiondate
FUSILEV Injection levoleucovorin calcium 50 mg/vial 020140 1 2013-12-19
FUSILEV Injection levoleucovorin calcium 10 mg/mL, 17.5 mL vial and 25 mL vial 020140 1 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
Sandoz Inc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 203563-001 Mar 9, 2015 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novast Labs LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 210623-002 May 3, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 208723-001 Sep 29, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 207547-001 Feb 13, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 206516-001 Feb 13, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for levoleucovorin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acrotech FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 See Plans and Pricing See Plans and Pricing
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 See Plans and Pricing See Plans and Pricing
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
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Moodys
McKesson
Baxter

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