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Last Updated: November 19, 2019

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Details for Patent: 8,221,747

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Summary for Patent: 8,221,747
Title:Stable pancreatic 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:12/034,488
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;

Drugs Protected by US Patent 8,221,747

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vivus Inc PANCREAZE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022523-005 Mar 7, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-007 Mar 25, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-005 Jun 15, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-001 Aug 27, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-002 Aug 27, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-003 Aug 27, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,221,747

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 065405   Start Trial
Australia 2008218595   Start Trial
Brazil PI0807718   Start Trial
Canada 2677989   Start Trial
Chile 2008000517   Start Trial
China 101686943   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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