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Last Updated: July 6, 2020

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MESALAMINE Drug Profile


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When do Mesalamine patents expire, and when can generic versions of Mesalamine launch?

Mesalamine is a drug marketed by Teva Pharms Usa, Mylan, G And W Labs Inc, Perrigo Israel, Amneal Pharms Llc, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Zydus Pharms, Actavis Labs Fl, and Sun Pharm. and is included in sixteen NDAs.

The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

US ANDA Litigation and Generic Entry Outlook for Mesalamine

A generic version of MESALAMINE was approved as mesalamine by PERRIGO ISRAEL on September 17th, 2004.

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Drug patent expirations by year for MESALAMINE
Drug Prices for MESALAMINE

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Drug Sales Revenue Trends for MESALAMINE

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Recent Clinical Trials for MESALAMINE

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SponsorPhase
AllerganPhase 1
Assembly BiosciencesPhase 1
Colitis & Crohn's Foundation (India)Phase 3

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Pharmacology for MESALAMINE
Drug ClassAminosalicylate
Medical Subject Heading (MeSH) Categories for MESALAMINE
Paragraph IV (Patent) Challenges for MESALAMINE
Tradename Dosage Ingredient NDA Submissiondate
DELZICOL CAPSULE, DELAYED RELEASE;ORAL mesalamine 204412 2014-06-17
CANASA SUPPOSITORY;RECTAL mesalamine 021252 2013-05-24
APRISO CAPSULE, EXTENDED RELEASE;ORAL mesalamine 022301 2012-04-03
ASACOL HD TABLET, DELAYED RELEASE;ORAL mesalamine 021830 2011-07-13
LIALDA TABLET, DELAYED RELEASE;ORAL mesalamine 022000 2009-12-16
ASACOL TABLET, DELAYED RELEASE;ORAL mesalamine 019651 2007-06-22

US Patents and Regulatory Information for MESALAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa MESALAMINE mesalamine CAPSULE, DELAYED RELEASE;ORAL 207873-001 May 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Annora Pharma MESALAMINE mesalamine SUPPOSITORY;RECTAL 213377-001 Mar 19, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Perrigo Israel MESALAMINE mesalamine ENEMA;RECTAL 076751-001 Sep 17, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203817-001 Mar 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
AstraZeneca
Johnson and Johnson
Merck
Boehringer Ingelheim

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