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Serving leading biopharmaceutical companies globally:

Accenture
Baxter
McKinsey
UBS
Medtronic
Express Scripts
Queensland Health
US Department of Justice
Mallinckrodt
Farmers Insurance

Generated: November 19, 2017

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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 Forest Labs Inc, Janssen Pharms, Abbvie, Digestive Care 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-one patent family members in twenty-nine countries.

There are six drug master file entries for pancrelipase (amylase;lipase;protease). Nine suppliers are listed for this compound.

Summary 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
Janssen Pharms
PANCREAZE
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022523-004Apr 12, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-003Aug 27, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Organon Usa Inc
COTAZYM
pancrelipase (amylase;lipase;protease)
CAPSULE;ORAL020580-001Dec 9, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Abbvie
CREON
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL020725-002Apr 30, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-002Aug 27, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-007Mar 25, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-006Jul 13, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-006Jul 13, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-006Jul 13, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Forest Labs Inc
ZENPEP
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL022210-003Aug 27, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,293,229Methods of producing stable pancreatic enzyme compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: pancrelipase (amylase;lipase;protease)

Country Document Number Estimated Expiration
Russian Federation2440101► Subscribe
Israel200407► Subscribe
Hong Kong1121037► Subscribe
Costa Rica20140422► Subscribe
Canada2619477► Subscribe
Israel189456► Subscribe
BrazilPI0807718► Subscribe
Portugal1931317► Subscribe
Spain2320174► Subscribe
South Korea20080034515► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Daiichi Sankyo
UBS
AstraZeneca
Boehringer Ingelheim
US Army
Colorcon
Cipla
Dow
US Department of Justice

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.

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