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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,562,981

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Which drugs does patent 8,562,981 protect, and when does it expire?


Patent 8,562,981 protects ZENPEP and is included in one NDA.

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

Summary for Patent: 8,562,981

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:13/019,860
Patent Claim Types:
see list of patent claims
Use; 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 Patent Submitted
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-007Mar 25, 2014RXYesNo► Subscribe► SubscribeTREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS► Subscribe
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-005Jun 15, 2011RXYesNo► Subscribe► SubscribeTREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS► Subscribe
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-002Aug 27, 2009RXYesNo► Subscribe► SubscribeTREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS► Subscribe
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-003Aug 27, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-001Aug 27, 2009RXYesNo► Subscribe► SubscribeTREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS► Subscribe
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-004Aug 27, 2009RXYesNo► Subscribe► SubscribeTREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS► Subscribe
Forest Labs IncZENPEPpancrelipase (amylase;lipase;protease)CAPSULE, DELAYED RELEASE;ORAL022210-006Jul 13, 2011RXYesYes► Subscribe► SubscribeTREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS► Subscribe
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Non-Orange Book Patents for Patent: 8,562,981

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

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Taiwan201422233► Subscribe
TaiwanI421090► Subscribe
Taiwan200843795► Subscribe
Singapore186648► Subscribe
Russian Federation2445952► Subscribe
Russian Federation2009135038► Subscribe
Portugal2079445► Subscribe
New Zealand598477► Subscribe
New Zealand579047► Subscribe
Mexico2009008828► 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:

Cerilliant
Merck
Queensland Health
Chubb
Fish and Richardson
Medtronic
Chinese Patent Office
UBS
AstraZeneca
Deloitte

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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