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FUSILEV Drug Profile
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When do Fusilev patents expire, and when can generic versions of Fusilev launch?
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. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for FUSILEV
| International Patents: | 21 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 4 |
| Patent Applications: | 153 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FUSILEV |
| DailyMed Link: | FUSILEV at DailyMed |
Medical Subject Heading (MeSH) Categories for FUSILEV
Synonyms for FUSILEV
| (S)-5-FORMYL-5,6,7,8-TETRAHYDROFOLIC ACID CALCIUM SALT |
| 1492-18-8 |
| 778XL6VBS8 |
| 80433-71-2 |
| A839909 |
| AB2000681 |
| AC-24017 |
| AKOS025401656 |
| AN-36399 |
| API0001819 |
| calcium (2S)-2-[[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]phenyl]-oxomethyl]amino]pentanedioate |
| calcium (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]pentanedioate |
| calcium (2S)-2-[[4-[[(6S)-2-azanyl-5-methanoyl-4-oxidanylidene-1,6,7,8-tetrahydropteridin-6-yl]methylamino]phenyl]carbonylamino]pentanedioate |
| calcium (6s)-folinate |
| calcium folinate |
| Calcium levofolinate |
| Calcium levofolinate (Calcium Folinate) |
| Calcium levofolinate (INN) |
| Calcium N-(p-((((6S)-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-L-glutamate (1:1) |
| calcium(2+) (2S)-2-{[4-({[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methyl}amino)phenyl]formamido}pentanedioate |
| CC0139 |
| CHEMBL1908361 |
| CL 307,782 |
| CL-307782 |
| CS-2466 |
| D04715 |
| D0Q6LA |
| D0V7RH |
| DTXSID3045564 |
| Elvorine |
| Elvorine|||Isovorin|||Calcium (2S)-2-[[4-[[(6S)-2-amino-5-formyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]pentanedioate |
| Folinic acid l-form calcium salt |
| Fusilev (TN) |
| HY-13667 |
| Isovorin |
| Isovorin (TN) |
| L-Glutamic acid, N-(4-(((2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-, calcium salt (1:1), (S)- |
| L-Leucovorin calcium |
| Levofolinate calcium (JAN) |
| Levoleucovorin (Calcium) |
| LEVOLEUCOVORIN CALCIUM |
| Levoleucovorin calcium (USAN) |
| Levoleucovorin calcium [USAN] |
| Levoleukovorin calcium |
| MFCD08704249 |
| MolPort-020-001-403 |
| SCHEMBL467144 |
| SCHEMBL9340225 |
| UNII-778XL6VBS8 |
| UNII-RPR1R4C0P4 component KVUAALJSMIVURS-QNTKWALQSA-L |
| W-60274 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spectrum Pharms | FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140-001 | Mar 7, 2008 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-002 | Apr 29, 2011 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Spectrum Pharms | FUSILEV | levoleucovorin calcium | POWDER;INTRAVENOUS | 020140-001 | Mar 7, 2008 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-002 | Apr 29, 2011 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for FUSILEV
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 10 mg/mL, 17.5 mL vial and 25 mL vial | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Injection | 50 mg/vial | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for FUSILEV
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 4,959,472 | Process for preparing substantially pure diastereoisomers of tetrahydrofolic derivatives | ➤ Sign Up |
| 6,849,628 | Optically active compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for FUSILEV
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Austria | 295173 | ➤ Sign Up |
| European Patent Office | 1275393 | ➤ Sign Up |
| South Africa | 8706562 | ➤ Sign Up |
| Germany | 3752362 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
