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Last Updated: March 28, 2024

FUSILEV Drug Patent Profile


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When do Fusilev patents expire, 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. Ten suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

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

See all FUSILEV clinical trials

Pharmacology for FUSILEV
Drug ClassFolate Analog
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 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 DISCN Yes 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 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 ⤷  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

International Patents for FUSILEV

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

Country Patent Number Title Estimated Expiration
Japan H11106342 COMPOSITION OBTAINED BY USING OPTICALLY ACTIVE COMPOUND ⤷  Try a Trial
South Africa 8706562 ⤷  Try a Trial
Spain 2189782 ⤷  Try a Trial
United Kingdom 8621268 ⤷  Try a Trial
Canada 1339368 COMPOSES OPTIQUEMENT ACTIFS (OPTICALLY ACTIVE COMPOUNDS) ⤷  Try a Trial
>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.