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Last Updated: June 28, 2022

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 and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-one patent family members in nine countries.

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

Summary for FUSILEV
Drug patent expirations by year for FUSILEV
Drug Prices for FUSILEV

See drug prices for FUSILEV

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
University of Southern CaliforniaPhase 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

FUSILEV is protected by one US patents.

Patents protecting FUSILEV

Substantially pure diastereoisomers of tetrahydrofolate derivatives
Patent Number: See Plans and Pricing
Patent Expiration: 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
Acrotech FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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
Acrotech FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y 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 FUSILEV

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 FUSILEV

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

Country Patent Number Title Estimated Expiration
United Kingdom 8621268 See Plans and Pricing
Japan 2844532 See Plans and Pricing
Austria 295173 See Plans and Pricing
Australia 598024 See Plans and Pricing
Austria 231150 See Plans and Pricing
Germany 3752361 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Merck
Moodys
Boehringer Ingelheim
Johnson and Johnson

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.