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FUSILEV Drug Profile
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See Plans and PricingWhen do Fusilev patents expire, and when can generic versions of Fusilev launch?
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. Twelve suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
US ANDA 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 50 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,053 |
| Drug Prices: | Drug price information for FUSILEV |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FUSILEV |
| 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 |
Recent Litigation for FUSILEV
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Spectrum Pharmaceuticals, Inc v. Sandoz Inc. | 2015-03-03 |
| Spectrum Pharmaceuticals, Inc. v. Eurohealth International Sarl | 2014-06-18 |
| Spectrum Pharmaceuticals Inc v. InnoPharma Inc. | 2012-03-02 |
Pharmacology for FUSILEV
| Drug Class | Folate Analog |
Paragraph IV (Patent) Challenges for FUSILEV
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FUSILEV | POWDER;INTRAVENOUS | levoleucovorin calcium | 020140 | 2013-12-19 |
| FUSILEV | SOLUTION;INTRAVENOUS | levoleucovorin calcium | 020140 | 2013-12-19 |
| FUSILEV | SOLUTION;INTRAVENOUS | levoleucovorin calcium | 020140 | 2011-10-26 |
| FUSILEV | POWDER;INTRAVENOUS | levoleucovorin calcium | 020140 | 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 | FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140-001 | Mar 7, 2008 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Acrotech | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-002 | Apr 29, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acrotech | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | Apr 29, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FUSILEV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0266042 | Start Trial |
| Canada | 1339368 | Start Trial |
| European Patent Office | 0608002 | Start Trial |
| South Africa | 8706562 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
