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FUSILEV Drug Profile
Which patents cover Fusilev, and what generic alternatives are available?
Fusilev is a drug marketed by Spectrum Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
The generic ingredient in FUSILEV is levoleucovorin calcium. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
Summary for FUSILEV
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 4 |
| Patent Applications: | 96 |
| 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 |
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 | ||
| Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | Apr 29, 2011 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | 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 |
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 |
International Patents for FUSILEV
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Spain | 2189782 | ➤ Sign Up |
| European Patent Office | 1275393 | ➤ Sign Up |
| Japan | H11106342 | ➤ Sign Up |
| Austria | 295173 | ➤ Sign Up |
| Germany | 3752362 | ➤ Sign Up |
| Japan | 2844532 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
