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Last Updated: June 18, 2024

FUSILEV Drug Patent Profile


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Which patents cover Fusilev, and what generic alternatives are available?

Fusilev is a drug marketed by Acrotech Biopharma and is included in one NDA.

The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fusilev

A generic version of FUSILEV was approved as levoleucovorin calcium by SANDOZ on March 9th, 2015.

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Drug patent expirations by year for FUSILEV
Drug Prices for FUSILEV

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Recent Clinical Trials for FUSILEV

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

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
Academic and Community Cancer Research UnitedPhase 1/Phase 2
National Cancer Institute (NCI)Phase 3

See all FUSILEV clinical trials

Paragraph IV (Patent) Challenges for FUSILEV
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 FUSILEV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech Biopharma FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 FUSILEV

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

International Patents for FUSILEV

See the table below for patents covering FUSILEV around the world.

Country Patent Number Title Estimated Expiration
Japan S63115880 OPTICALLY ACTIVE COMPOUND ⤷  Sign Up
European Patent Office 0608002 Des composés optiquement actifs (Optically active compounds) ⤷  Sign Up
Japan 2000136135 COMPOSITION USING OPTICALLY ACTIVE COMPOUND ⤷  Sign Up
Spain 2189782 ⤷  Sign Up
Spain 2191669 ⤷  Sign Up
Australia 598024 ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.