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FUSILEV Drug Profile
When do Fusilev patents expire, and when can generic versions of Fusilev launch?
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.
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. Ten 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: | 33 |
| Clinical Trials: | 5 |
| 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 | ||
| 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 |
|---|---|---|
| European Patent Office | 1275393 | ➤ Sign Up |
| Japan | S63115880 | ➤ Sign Up |
| Australia | 598024 | ➤ Sign Up |
| European Patent Office | 0608002 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
