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. 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. Eight 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 INC on March 9th, 2015.
Summary for FUSILEV
International Patents: | 21 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 5 |
Patent Applications: | 6,401 |
Drug Prices: | Drug price information for FUSILEV |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FUSILEV |
What excipients (inactive ingredients) are in FUSILEV? | FUSILEV excipients list |
DailyMed Link: | FUSILEV at DailyMed |


Recent Clinical Trials for FUSILEV
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Academic and Community Cancer Research United | Phase 1/Phase 2 |
National Cancer Institute (NCI) | Phase 1/Phase 2 |
National Cancer Institute (NCI) | Phase 3 |
Pharmacology for FUSILEV
Drug Class | Folate 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
FUSILEV is protected by one US patents.
Patents protecting FUSILEV
Substantially pure diastereoisomers of tetrahydrofolate derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acrotech Biopharma | FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140-001 | Mar 7, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-002 | Apr 29, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | Apr 29, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 | 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 |
International Patents for FUSILEV
See the table below for patents covering FUSILEV around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 0266042 | Dérivés de ptéridine optiquement actifs (Optically active pteridine derivatives) | ⤷ Try a Trial |
Australia | 7777587 | ⤷ Try a Trial | |
South Africa | 8706562 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |