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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-five drug master file entries for mesalamine. Eighteen 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 list25
Suppliers / Packaging: see list18
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Tentative approvals for MESALAMINE

Applicant Application No. Form Dosage
<disabled><disabled>SUPPOSITORY;RECTAL1000MG

Clinical Trials for: mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes9,089,492<disabled>Y <disabled>
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYes8,911,778<disabled>Y <disabled>
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYes8,940,328<disabled>Y <disabled>
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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
Meda Pharms
ROWASA
mesalamine
ENEMA;RECTAL019618-001Dec 24, 1987RE33239<disabled>
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,171<disabled>
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,171<disabled>
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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<disabled in preview>
8,217,082Reduced irritant enema for the treatment of inflammatory bowel disease (IBD)<disabled in preview>
7,541,384Mesalamine suppository<disabled in preview>
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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
ItalyMI991316<disabled in preview>
Portugal1198226<disabled in preview>
China1314390<disabled in preview>
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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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