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.
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 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 5 |
| Patent Applications: | 5,926 |
| 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 |
| University of Southern California | Phase 3 |
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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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.
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