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Last Updated: June 4, 2020

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Details for Patent: 8,562,978


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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;

Drugs Protected by US Patent 8,562,978

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 8,562,978

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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