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Last Updated: March 28, 2024

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 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
United States Department of DefensePhase 2
Phoenix Children's HospitalPhase 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 210623-002 May 3, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 211003-001 Aug 22, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;INTRAVENOUS 203563-001 Mar 9, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;INTRAVENOUS 208723-001 Sep 29, 2016 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 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
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.