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Serving leading biopharmaceutical companies globally:

Medtronic
Queensland Health
Express Scripts
Deloitte
UBS
Chubb
Fish and Richardson
McKesson
Cantor Fitzgerald
Citi

Generated: January 23, 2018

DrugPatentWatch Database Preview

Levoleucovorin calcium - Generic Drug Details

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What are the generic drug sources for levoleucovorin calcium and what is the scope of levoleucovorin calcium patent protection?

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

Levoleucovorin calcium 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 levoleucovorin calcium
Medical Subject Heading (MeSH) Categories for levoleucovorin calcium

US Patents and Regulatory Information for levoleucovorin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Llc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;IV (INFUSION) 208723-001 Sep 29, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium POWDER;IV (INFUSION) 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;IV (INFUSION) 206263-001 Jun 16, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-002 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sandoz Inc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;IV (INFUSION) 203563-001 Mar 9, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Amneal Pharms Co LEVOLEUCOVORIN CALCIUM levoleucovorin calcium POWDER;IV (INFUSION) 207547-001 Feb 13, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz Inc LEVOLEUCOVORIN CALCIUM levoleucovorin calcium SOLUTION;IV (INFUSION) 203563-002 Mar 9, 2015 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-003 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium SOLUTION;IV (INFUSION) 020140-002 Apr 29, 2011 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms FUSILEV levoleucovorin calcium POWDER;IV (INFUSION) 020140-001 Mar 7, 2008 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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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Non-Orange Book US Patents for 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
Patent No. Title Estimated Patent Expiration

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International Patents for levoleucovorin calcium

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Serving leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Chinese Patent Office
Fish and Richardson
Novartis
Harvard Business School
Deloitte
Fuji
QuintilesIMS

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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