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 Claims: | see list of patent claims |
Details for Patent 8,562,978
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc. | COTAZYM | pancrelipase | Capsule, Delayed Release | 020580 | December 09, 1996 | ⤷ Sign Up | 2027-02-20 |
Abbvie Inc. | CREON | pancrelipase | Capsule, Delayed Release | 020725 | April 30, 2009 | ⤷ Sign Up | 2027-02-20 |
Abbvie Inc. | CREON | pancrelipase | Capsule, Delayed Release | 020725 | June 10, 2011 | ⤷ Sign Up | 2027-02-20 |
Abbvie Inc. | CREON | pancrelipase | Capsule, Delayed Release | 020725 | March 14, 2013 | ⤷ Sign Up | 2027-02-20 |
Digestive Care, Inc. | PERTZYE | pancrelipase | Capsule, Delayed Release | 022175 | May 17, 2012 | ⤷ Sign Up | 2027-02-20 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
International Patent Family for US Patent 8,562,978
Country | Patent Number | Estimated Expiration |
---|---|---|
Argentina | 065405 | ⤷ Sign Up |
Australia | 2008218595 | ⤷ Sign Up |
Brazil | PI0807718 | ⤷ Sign Up |
Canada | 2677989 | ⤷ Sign Up |
Chile | 2008000517 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |