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Last Updated: July 9, 2020

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Patent: 8,562,980

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Summary for Patent: 8,562,980
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:13/019,856
Patent Claims:see list of patent claims

Details for Patent 8,562,980

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Zenpep ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 007 2009-08-27   Start Trial Aptalis Pharma Limited (Wicklow, IE) 2027-02-20 RX company
Zenpep ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 006 2009-08-27   Start Trial Aptalis Pharma Limited (Wicklow, IE) 2027-02-20 RX company
Zenpep ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 005 2009-08-27   Start Trial Aptalis Pharma Limited (Wicklow, IE) 2027-02-20 RX company
Zenpep ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 004 2009-08-27   Start Trial Aptalis Pharma Limited (Wicklow, IE) 2027-02-20 RX company
Zenpep ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 003 2009-08-27   Start Trial Aptalis Pharma Limited (Wicklow, IE) 2027-02-20 RX company
Zenpep ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 002 2009-08-27   Start Trial Aptalis Pharma Limited (Wicklow, IE) 2027-02-20 RX company
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

International Patent Family for US Patent 8,562,980

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