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Last Updated: November 2, 2024

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, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc. and is included in twenty-nine NDAs.

The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Forty 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
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Drug Sales Revenue Trends for MESALAMINE

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Recent Clinical Trials for MESALAMINE

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SponsorPhase
Tanta UniversityN/A
AHS Cancer Control AlbertaPhase 2
Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta UniversityPhase 2

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 Strength NDA ANDAs Submitted Submissiondate
DELZICOL Delayed-release Capsules mesalamine 400 mg 204412 1 2014-06-17
CANASA Suppository mesalamine 1000 mg 021252 1 2013-05-24
APRISO Extended-release Capsules mesalamine 0.375 g 022301 1 2012-04-03
ASACOL HD Delayed-release Tablets mesalamine 800 mg 021830 1 2011-07-13
LIALDA Delayed-release Tablets mesalamine 1.2 g 022000 1 2009-12-16
ASACOL Delayed-release Tablets mesalamine 400 mg 019651 1 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
Zydus Pharms MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 091640-001 Jun 5, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203286-001 Jul 21, 2017 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa MESALAMINE mesalamine CAPSULE, DELAYED RELEASE;ORAL 207873-001 May 9, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan MESALAMINE mesalamine SUPPOSITORY;RECTAL 204354-001 Nov 24, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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