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Last Updated: April 16, 2024

Levoleucovorin calcium - Generic Drug Details


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What are the generic sources for levoleucovorin calcium and what is the scope of freedom to operate?

Levoleucovorin calcium is the generic ingredient in two branded drugs marketed by Acrotech Biopharma, Actavis Llc, Amneal, Hikma, Meitheal, Ailex Pharms Llc, Gland Pharma Ltd, Hainan Poly Pharm, Mylan Teoranta, Novast Labs, and Sandoz, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for levoleucovorin calcium

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

SponsorPhase
Autism SpeaksPhase 2
Phoenix Children's HospitalPhase 2
State University of New York - Downstate Medical CenterPhase 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hainan Poly Pharm LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 217314-001 May 22, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 206516-001 Feb 13, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 207547-001 Feb 13, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 207548-001 Sep 8, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 206263-001 Jun 16, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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