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Last Updated: June 25, 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
New York State Institute for Basic ResearchPhase 2
United States Department of DefensePhase 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
Novast Labs LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 210623-001 May 3, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Praxgen LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 213797-001 Nov 2, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gland Pharma Ltd LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 210892-002 Sep 14, 2018 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 207548-001 Sep 8, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
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
>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

International Patents for LEVOLEUCOVORIN CALCIUM

Country Patent Number Title Estimated Expiration
European Patent Office 0608002 Des composés optiquement actifs (Optically active compounds) See Plans and Pricing
European Patent Office 1275393 Composition pharmaceutique contenant un dérivé de ptéridine (Pharmaceutical formulation containing pteridine derivative) See Plans and Pricing
United Kingdom 8621268 See Plans and Pricing
Japan H11106342 COMPOSITION OBTAINED BY USING OPTICALLY ACTIVE COMPOUND See Plans and Pricing
Germany 3752384 See Plans and Pricing
Germany 3752362 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
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Harvard Business School
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McKesson

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