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Last Updated: March 29, 2024

Mesalamine - Generic Drug Details


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What are the generic sources for mesalamine and what is the scope of patent protection?

Mesalamine is the generic ingredient in ten branded drugs marketed by Abbvie, Teva Pharms Usa, Salix, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Sun Pharm, Zydus Pharms, Takeda Pharms Usa, Encube, G And W Labs Inc, Padagis Israel, Mylan Speciality Lp, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz, Meda Pharms, Apil, Actavis Labs Fl, and Sinotherapeutics Inc, and is included in thirty-six NDAs. There are four patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has thirty-six patent family members in eighteen countries.

There are twenty-eight drug master file entries for mesalamine. Thirty-six suppliers are listed for this compound.

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
AHS Cancer Control AlbertaPhase 2
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta UniversityPhase 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
Encube MESALAMINE mesalamine ENEMA;RECTAL 216941-001 May 30, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000-001 Jan 16, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie CANASA mesalamine SUPPOSITORY;RECTAL 021252-002 Nov 5, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pharm Sourcing MESALAMINE mesalamine SUPPOSITORY;RECTAL 207448-001 Apr 19, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ⤷  Try a Trial ⤷  Try a Trial
Abbvie DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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