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Serving leading biopharmaceutical companies globally:

Merck
Citi
Cantor Fitzgerald
Baxter
Chinese Patent Office
US Department of Justice
Boehringer Ingelheim
Express Scripts
Queensland Health
Covington

Generated: December 17, 2017

DrugPatentWatch Database Preview

SYNRIBO Drug Profile

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Which patents cover Synribo, and what generic alternatives are available?

Synribo is a drug marketed by Teva Pharms Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in nineteen countries.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.

Summary for SYNRIBO

Drug patent expirations by year for SYNRIBO

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms IntlSYNRIBOomacetaxine mepesuccinatePOWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Teva Pharms IntlSYNRIBOomacetaxine mepesuccinatePOWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Teva Pharms IntlSYNRIBOomacetaxine mepesuccinatePOWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes► Subscribe► SubscribeYY► Subscribe
Teva Pharms IntlSYNRIBOomacetaxine mepesuccinatePOWDER;SUBCUTANEOUS203585-001Oct 26, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for SYNRIBO

Drugname Dosage Strength RLD Submissiondate
omacetaxine mepesuccinatefor Injection3.5 mg/vialSynribo10/26/2016

Non-Orange Book Patents for Tradename: SYNRIBO

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
7,842,687Cephalotaxane derivatives and their processes of preparation and purification► Subscribe
7,169,774Cephalotaxane derivatives and their processes of preparation and purification► 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 Tradename: SYNRIBO

Country Document Number Estimated Expiration
Japan4942871► Subscribe
Portugal1064285► Subscribe
Japan2004523586► Subscribe
China1220692► Subscribe
Japan2015117251► Subscribe
Canada2324895► Subscribe
Hong Kong1067562► Subscribe
Germany69923768► Subscribe
Hungary0101375► Subscribe
Portugal1443933► 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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Serving leading biopharmaceutical companies globally:

US Army
Teva
Federal Trade Commission
AstraZeneca
Chubb
Novartis
Cerilliant
Cantor Fitzgerald
Fuji
Cipla

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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