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Levoleucovorin calcium - Generic Drug Details

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Levoleucovorin calcium is the generic ingredient in two branded drugs marketed by Actavis Llc, Spectrum Pharms, West-ward Pharms Int, Sandoz Inc, and Mylan Teoranta, and is included in five NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-one patent family members in nine countries.

There is one drug master file entry for levoleucovorin calcium. Five suppliers are listed for this compound.

Summary for Generic Name: levoleucovorin calcium

Tradenames:2
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list1
Suppliers / Packaging: see list5
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-003Apr 29, 2011DISCNNo6,500,829► subscribeYY ► subscribe
Spectrum Pharms
FUSILEV
levoleucovorin calcium
POWDER;IV (INFUSION)020140-001Mar 7, 2008RXYes6,500,829► subscribeYY ► subscribe
Sandoz Inc
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
SOLUTION;IV (INFUSION)203563-001Mar 9, 2015RXNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: levoleucovorin calcium

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► subscribe
6,849,628 Optically active compounds► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: levoleucovorin calcium

Country Document Number Estimated Expiration
Germany3752361► subscribe
United Kingdom8621268► subscribe
Austria295173► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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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