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Generated: May 26, 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 Shire, Valeant Pharms Intl, Apil, Mylan Speciality Lp, Meda Pharms, G And W Labs Inc, Perrigo Israel, Forest Labs Llc, and Mylan Pharms Inc, and is included in twelve NDAs. There are sixteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has ninety-four patent family members in twenty-seven countries.

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

Summary for Generic Name: mesalamine

Tradenames:10
Patents:16
Applicants:9
NDAs:12
Drug Master File Entries: see list27
Suppliers / Packagers: see list21
Bulk Api Vendors: see list112
Clinical Trials: see list26
Patent Applications: see list6,098
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mesalamine at DailyMed

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Tentative approvals for MESALAMINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe1000MGSUPPOSITORY;RECTAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-002Jul 8, 2004RXYesYes► Subscribe► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes8,337,886► SubscribeY ► Subscribe
Forest Labs Llc
CANASA
mesalamine
SUPPOSITORY;RECTAL021252-002Nov 5, 2004ABRXYesYes8,436,051► SubscribeY ► Subscribe
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXYesNo► Subscribe► Subscribe
G And W Labs Inc
MESALAMINE
mesalamine
ENEMA;RECTAL076841-001Sep 30, 2004ABRXNoNo► Subscribe► Subscribe
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