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Last Updated: October 20, 2021

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MESALAMINE Drug Patent 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, Alkem Labs Ltd, Mylan, Zydus Pharms, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Actavis Labs Fl, and Sun Pharm. and is included in nineteen NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Mesalamine

A generic version of MESALAMINE was approved as mesalamine by PADAGIS 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ann-Sofie BackmanPhase 2
The Swedish Research CouncilPhase 2
AllerganPhase 1

See all MESALAMINE clinical trials

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 091640-001 Jun 5, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Actavis Mid Atlantic MESALAMINE mesalamine SUPPOSITORY;RECTAL 205654-001 Aug 14, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

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 verification 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.