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Details for Patent: 6,500,829

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Patent 6,500,829 protects FUSILEV and is included in one NDA. There have been two Paragraph IV challenges on Fusilev.

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

Summary for Patent: 6,500,829

Title: Substantially pure diastereoisomers of tetrahydrofolate derivatives
Abstract:The present invention related to the preparation of substantially pure diastereoisomers of derivatives of tetrahydrofolate and the use of such diastereoisomers. More particularly the present invention provides a process for the preparation of a desired substantially pure (6R or 6S) diastereoisomer of a derivative of tetrahydrofolic acid or salt or ester. The process comprises the steps of: attaching a chiral auxiliary group at either N-5 or N-10 of a mixture of 6R and 6S diastereoisomers of tetrahydrofolic acid, separating the new diastereoisomers, recovering the desired new diastereoisomer (6R or 6S) corresponding to the desired (6R or 6S) diastereoisomer, and converting the substantially pure new diastereoisomer recovered into the corresponding diastereoisomer.
Inventor(s): Wood; Hamish Christopher Swan (Glasgow, GB), Suckling; Colin James (Glasgow, GB), Rees; Lilias G. (Glasgow, GB)
Assignee: University of Strathclyde (Glasgow, GB)
Application Number:08/426,458
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Spectrum Pharms
FUSILEV
levoleucovorin calcium
POWDER;IV (INFUSION)020140-001Mar 7, 2008RXYes6,500,829► subscribeYY
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-002Apr 29, 2011DISCNNo6,500,829► subscribeYY
Spectrum Pharms
FUSILEV
levoleucovorin calcium
SOLUTION;IV (INFUSION)020140-003Apr 29, 2011DISCNNo6,500,829► subscribeYY
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Foreign Priority and PCT Information for Patent: 6,500,829

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom8621268Sep 03, 1986

Non-Orange Book Patents for Patent: 6,500,829

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 Patent: 6,500,829

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria230746► subscribe
Austria231150► 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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