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Serving leading biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
Mallinckrodt
McKinsey
Moodys
McKesson
Queensland Health
QuintilesIMS
Cerilliant
Cantor Fitzgerald

Generated: December 16, 2017

DrugPatentWatch Database Preview

ASACOL HD Drug Profile

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When do Asacol Hd patents expire, and what generic alternatives are available?

Asacol Hd is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in seventeen countries.

The generic ingredient in ASACOL HD is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Drug patent expirations by year for ASACOL HD

Pharmacology for ASACOL HD

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Medical Subject Heading (MeSH) Categories for ASACOL HD

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for ASACOL HD

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Tablets800 mgAsacol HD7/13/2011

International Patent Family for Tradename: ASACOL HD

Country Document Number Estimated Expiration
China1558754► Subscribe
Germany60133319► Subscribe
China1314390► Subscribe
Canada2359812► Subscribe
Australia2002226955► Subscribe
Denmark1453487► Subscribe
Israel161628► Subscribe
New Zealand532564► Subscribe
MexicoPA04004747► Subscribe
Hungary0402230► 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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Serving leading biopharmaceutical companies globally:

Medtronic
Chubb
US Army
Argus Health
Boehringer Ingelheim
Julphar
Chinese Patent Office
Mallinckrodt
Merck
Healthtrust

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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