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Generated: February 24, 2018

DrugPatentWatch Database Preview

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 Patent Submitted
Janssen Pharms PANCREAZE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022523-005 Mar 7, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-007 Mar 25, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-005 Jun 15, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-001 Aug 27, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-002 Aug 27, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-003 Aug 27, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-004 Aug 27, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-006 Jul 13, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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

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Non-Orange Book US Patents Family Members for Patent 8,562,978

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
7,658,918 Stable digestive enzyme compositions ➤ Try a Free Trial
8,293,229 Methods of producing stable pancreatic enzyme compositions ➤ Try a Free Trial
8,562,979 Stable digestive enzyme compositions ➤ Try a Free Trial
8,562,981 Stable digestive enzyme compositions ➤ Try a Free Trial
8,562,980 Stable digestive enzyme compositions ➤ Try a Free Trial
8,221,747 Stable pancreatic enzyme compositions ➤ Try a Free Trial
8,246,950 Stable digestive enzyme compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,562,978

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Portugal 2079445 ➤ Try a Free Trial
Russian Federation 2009135038 ➤ Try a Free Trial
Taiwan 200843795 ➤ Try a Free Trial
Singapore 186648 ➤ Try a Free Trial
Russian Federation 2445952 ➤ Try a Free Trial
New Zealand 598477 ➤ Try a Free Trial
New Zealand 579047 ➤ Try a Free Trial
Malaysia 163469 ➤ Try a Free Trial
South Korea 20150038322 ➤ Try a Free Trial
Mexico 2009008828 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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Boehringer Ingelheim
Federal Trade Commission
Argus Health
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Harvard Business School

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