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Details for Patent: RE45128

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Patent RE45128 protects SYNRIBO and is included in one NDA.

This patent has twenty-five patent family members in seventeen countries.

Summary for Patent: RE45128

Title:Cephalotaxane derivatives and their processes of preparation and purification
Abstract: The present invention concerns a new general process for asymmetric hemisynthesis of harringtonines and their analogs, that are alkaloids used in chemotherapy. This process comprises direct esterification of a natural cephalotaxine with an acylating compound constituted of a side chain precursor which backbone and functionalization are entirely preformed. The invention also concerns a natural, synthetic or semi-synthetic harringtonines including their tautomeric forms and their salts of the following formula: ##STR00001## wherein n=2 (i.e. harringtonine) or n=3 (i.e. homoharringtonine), in which the total content of impurities, possibly including enantiomeric forms, is lower than 1%, and/or the content of the major impurity is lower than 0.9%, and/or the chromatographic assay exhibits a harringtonines content higher than 97.5%.
Inventor(s): Robin; Jean-Pierre (Geneva, CH), Blanchard; Julie (Puyricard, FR), Marie; Jean-Pierre (Sevres, FR), Radosevic; Nina (Geneva, CH)
Assignee: IVAX International GmbH (Rapperswil, CH)
Application Number:13/661,677
Patent Claim Types:
see list of patent claims
Compound; Composition; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Ivax Intl
SYNRIBO
omacetaxine mepesuccinate
POWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesRE45128► subscribeYY TREATMENT OF LEUKEMIA
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Foreign Priority and PCT Information for Patent: RE45128

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
France98 03492Mar 20, 1998

Non-Orange Book Patents for Patent: RE45128

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
7,842,687Cephalotaxane derivatives and their processes of preparation and purification► subscribe
6,613,900 Cephalotaxane derivatives and process for their preparation► subscribe
6,831,180 Cephalotaxane derivatives and process for their preparation► 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: RE45128

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria289312► subscribe
Australia2002304338► subscribe
Australia3270699► 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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