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Mesalamine - Generic Drug Details

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

This ingredient has ninety-three patent family members in twenty-seven countries.

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

Summary for Generic Name: mesalamine

Tradenames:10
Patents:15
Applicants:8
NDAs:12
Drug Master File Entries: see list26
Suppliers / Packaging: see list22
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Tentative approvals for MESALAMINE

Applicant Application No. Form Dosage
<disabled><disabled>SUPPOSITORY;RECTAL1000MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo Israel
MESALAMINE
mesalamine
ENEMA;RECTAL076751-001Sep 17, 2004RXNo► subscribe► subscribe
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXNo► subscribe► subscribe
Forest Labs Llc
CANASA
mesalamine
SUPPOSITORY;RECTAL021252-002Nov 5, 2004RXYes8,436,051► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: mesalamine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,170► subscribe
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,496,553► subscribe
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 20085,541,170► 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
8,217,082Reduced irritant enema for the treatment of inflammatory bowel disease (IBD)► subscribe
6,277,412 Pellet-type formulation intended for treating 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
Japan2000297102► subscribe
World Intellectual Property Organization (WIPO)0076481► subscribe
Denmark2107870► 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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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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