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Serving leading biopharmaceutical companies globally:

Moodys
Chubb
Cerilliant
Citi
Fish and Richardson
Chinese Patent Office
Daiichi Sankyo
Express Scripts
Fuji
Baxter

Generated: December 12, 2017

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Mesalamine - Generic Drug Details

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What are the generic sources for mesalamine and what is the scope of mesalamine freedom to operate?

Mesalamine
is the generic ingredient in ten branded drugs marketed by Apil, Valeant Pharms Intl, Shire, G And W Labs Inc, Perrigo Israel, Mylan Speciality Lp, Forest Labs Llc, Mylan Pharms Inc, Meda Pharms, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. There are fifteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has one hundred and three patent family members in twenty-seven countries.

There are twenty-eight drug master file entries for mesalamine. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Medical Subject Heading (MeSH) Categories for mesalamine

Tentative approvals for MESALAMINE

Applicant Application No. Strength Dosage Form
u► Subscribe1000MGSUPPOSITORY;RECTAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Speciality LpROWASAmesalamineENEMA;RECTAL019618-001Dec 24, 1987ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Perrigo IsraelMESALAMINEmesalamineENEMA;RECTAL076751-001Sep 17, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ShireLIALDAmesalamineTABLET, DELAYED RELEASE;ORAL022000-001Jan 16, 2007ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Forest Labs LlcCANASAmesalamineSUPPOSITORY;RECTAL021252-002Nov 5, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ApilASACOLmesalamineTABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992► Subscribe► Subscribe
ApilDELZICOLmesalamineCAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013► Subscribe► Subscribe
ApilASACOLmesalamineTABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992► Subscribe► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008► Subscribe► Subscribe
Mylan Speciality LpROWASAmesalamineENEMA;RECTAL019618-001Dec 24, 1987► Subscribe► Subscribe
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008► Subscribe► Subscribe
Mylan Speciality LpROWASAmesalamineENEMA;RECTAL019618-001Dec 24, 1987► Subscribe► Subscribe
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
ApilDELZICOLmesalamineCAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: mesalamine

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
6,277,412 Pellet-type formulation intended for treating the intestinal tract► Subscribe
8,217,082Reduced irritant enema for the treatment of inflammatory bowel disease (IBD)► Subscribe
7,547,451Pellet formulation for the treatment of the intestinal tract► Subscribe
7,541,384Mesalamine suppository► 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: mesalamine

Country Document Number Estimated Expiration
Japan4727875► Subscribe
New Zealand578674► Subscribe
Singapore181169► Subscribe
Denmark0977557► Subscribe
Mexico2012006902► Subscribe
Austria235234► Subscribe
Hong Kong1085669► Subscribe
Mexico2011003595► Subscribe
Germany60027608► Subscribe
Canada2739465► 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 plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Novartis
Baxter
McKinsey
Boehringer Ingelheim
Julphar
Chinese Patent Office
UBS
Teva
Colorcon

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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