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Omacetaxine mepesuccinate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for omacetaxine mepesuccinate?

Omacetaxine mepesuccinate is the generic ingredient in one branded drug marketed by Ivax Intl and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omacetaxine mepesuccinate has forty-two patent family members in nineteen countries.

There are two drug master file entries for omacetaxine mepesuccinate. One supplier is listed for this compound.

Summary for Generic Name: omacetaxine mepesuccinate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list27
Clinical Trials: see list15
Patent Applications: see list8
Drug Prices:see low prices
DailyMed Link:omacetaxine mepesuccinate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Intl
SYNRIBO
omacetaxine mepesuccinate
POWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes6,987,103► Subscribe ► Subscribe
Ivax Intl
SYNRIBO
omacetaxine mepesuccinate
POWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYesRE45128► SubscribeYY ► Subscribe
Ivax Intl
SYNRIBO
omacetaxine mepesuccinate
POWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes► Subscribe► Subscribe
Ivax Intl
SYNRIBO
omacetaxine mepesuccinate
POWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: omacetaxine mepesuccinate

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
6,613,900 Cephalotaxane derivatives and process for their preparation► Subscribe
6,831,180 Cephalotaxane derivatives and process for their preparation► Subscribe
7,842,687Cephalotaxane derivatives and their processes of preparation and purification► Subscribe
7,169,774Cephalotaxane derivatives and their processes of preparation and purification► 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: omacetaxine mepesuccinate

Country Document Number Estimated Expiration
Portugal1443933► Subscribe
Denmark1064285► Subscribe
Hungary0101375► Subscribe
China1300289► Subscribe
Japan2009132735► 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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