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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Moodys
McKinsey
Cerilliant
Harvard Business School
Federal Trade Commission
Cantor Fitzgerald
US Department of Justice
Julphar

Generated: May 22, 2018

DrugPatentWatch Database Preview

Pancrelipase (amylase;lipase;protease) - Generic Drug Details

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What are the generic drug sources for pancrelipase (amylase;lipase;protease) and what is the scope of pancrelipase (amylase;lipase;protease) patent protection?

Pancrelipase (amylase;lipase;protease)
is the generic ingredient in seven branded drugs marketed by Abbvie, Janssen Pharms, Digestive Care Inc, Forest Labs Inc, and Organon Usa Inc, and is included in seven NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pancrelipase (amylase;lipase;protease) has eighty-three patent family members in thirty-one countries.

There are six drug master file entries for pancrelipase (amylase;lipase;protease). Seven suppliers are listed for this compound.
Summary for pancrelipase (amylase;lipase;protease)
International Patents:83
US Patents:8
Tradenames:7
Applicants:5
NDAs:7
Drug Master File Entries: 6
Suppliers / Packagers: 7
Clinical Trials: 800
DailyMed Link:pancrelipase (amylase;lipase;protease) at DailyMed

US Patents and Regulatory Information for pancrelipase (amylase;lipase;protease)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Inc ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210-006 Jul 13, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms PANCREAZE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022523-005 Mar 7, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms PANCREAZE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022523-005 Mar 7, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie CREON pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 020725-005 Mar 14, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for pancrelipase (amylase;lipase;protease)

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
8,293,229 Methods of producing stable pancreatic enzyme compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cipla
Fish and Richardson
Chubb
QuintilesIMS
Johnson and Johnson
Dow
Boehringer Ingelheim
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.