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Levoleucovorin calcium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for levoleucovorin calcium?

Levoleucovorin calcium is the generic ingredient in two branded drugs marketed by Actavis Llc, Spectrum Pharms, Amneal Pharms Co, West-ward Pharms Int, Sandoz Inc, and Mylan Teoranta, and is included in seven 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. Six suppliers are listed for this compound.

Summary for Generic Name: levoleucovorin calcium

Tradenames:2
Patents:2
Applicants:6
NDAs:7
Drug Master File Entries: see list1
Suppliers / Packagers: see list6
Bulk Api Vendors: see list25
Clinical Trials: see list724
Patent Applications: see list2,257
Drug Prices:see low prices
DailyMed Link:levoleucovorin calcium at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-003Apr 29, 2011DISCNYesNo► Subscribe► Subscribe
Actavis Llc
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
POWDER;IV (INFUSION)206516-001Feb 13, 2017RXNoNo► Subscribe► Subscribe
Mylan Teoranta
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
SOLUTION;IV (INFUSION)203576-001Oct 20, 2015RXNoNo► Subscribe► Subscribe
Amneal Pharms Co
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
POWDER;IV (INFUSION)207547-001Feb 13, 2017RXNoNo► Subscribe► Subscribe
West-ward Pharms Int
LEVOLEUCOVORIN CALCIUM
levoleucovorin calcium
POWDER;IV (INFUSION)206263-001Jun 16, 2016RXNoNo► 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
6,849,628 Optically active compounds► Subscribe
4,959,472 Process for preparing substantially pure diastereoisomers of tetrahydrofolic derivatives► 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
Spain2191669► Subscribe
Austria230746► Subscribe
JapanS63115880► Subscribe
European Patent Office0266042► Subscribe
Germany3752362► 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.

Export unavailable in trial.
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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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