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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?

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

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
CAPSULE, EXTENDED RELEASE;ORAL020049-002Jul 8, 2004RXYesYes► Subscribe► Subscribe
Valeant Pharms Intl
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes8,337,886► SubscribeY ► Subscribe
Forest Labs Llc
SUPPOSITORY;RECTAL021252-002Nov 5, 2004ABRXYesYes8,436,051► SubscribeY ► Subscribe
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXYesNo► Subscribe► Subscribe
G And W Labs Inc
ENEMA;RECTAL076841-001Sep 30, 2004ABRXNoNo► Subscribe► Subscribe
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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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