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Serving leading biopharmaceutical companies globally:

Queensland Health
McKinsey
Deloitte
Mallinckrodt
Baxter
Citi
Cipla
Moodys
Farmers Insurance
Covington

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,562,978

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Which drugs does patent 8,562,978 protect, and when does it expire?


Patent 8,562,978 protects ZENPEP and is included in one NDA.

This patent has thirty-three patent family members in twenty-three countries.

Summary for Patent: 8,562,978

Title:Stable digestive enzyme compositions
Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.
Inventor(s): Ortenzi; Giovanni (Monza, IT), Marconi; Marco (Cinisello Balsamo, IT), Mapelli; Luigi (Milan, IT)
Assignee: Aptalis Pharma Limited (Wicklow, IE)
Application Number:12/832,596
Patent Claim Types:
see list of patent claims
Composition; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-007Mar 25, 2014RXYesNo► Subscribe► SubscribeY
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-005Jun 15, 2011RXYesNo► Subscribe► SubscribeY
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-002Aug 27, 2009RXYesNo► Subscribe► SubscribeY
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-003Aug 27, 2009RXYesNo► Subscribe► SubscribeY
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-001Aug 27, 2009RXYesNo► Subscribe► SubscribeY
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-004Aug 27, 2009RXYesNo► Subscribe► SubscribeY
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-006Jul 13, 2011RXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 8,562,978

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
8,562,979Stable digestive enzyme compositions► Subscribe
7,658,918Stable digestive enzyme compositions► Subscribe
8,246,950Stable digestive enzyme compositions► Subscribe
8,293,229Methods of producing stable pancreatic enzyme compositions► Subscribe
8,562,980Stable digestive enzyme compositions► Subscribe
8,221,747Stable pancreatic enzyme compositions► Subscribe
8,562,981Stable digestive enzyme compositions► 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: 8,562,978

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina065405► Subscribe
Australia2008218595► Subscribe
BrazilPI0807718► Subscribe
Canada2677989► Subscribe
Chile2008000517► Subscribe
China101686943► Subscribe
China103933555► Subscribe
Colombia6220903► Subscribe
Costa Rica11031► Subscribe
Costa Rica20140422► 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:

Argus Health
Cerilliant
Deloitte
Boehringer Ingelheim
Fish and Richardson
US Army
Colorcon
McKinsey
Express Scripts
Federal Trade Commission

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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