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Last Updated: March 28, 2024

Mesalamine - Generic Drug Details


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What are the generic drug 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
Meda Pharms ROWASA mesalamine SUPPOSITORY;RECTAL 019919-001 Dec 18, 1990 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan MESALAMINE mesalamine SUPPOSITORY;RECTAL 204354-001 Nov 24, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz MESALAMINE mesalamine SUPPOSITORY;RECTAL 202065-001 Jun 12, 2019 AB RX No No ⤷  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
>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

International Patents for mesalamine

Country Patent Number Title Estimated Expiration
Chile 2012001636 Supositorio rectal de mesalamina , en donde las particulas de mesalamina tienen un area de superficie de 0,1 m2/g a 1,3 m2/g, util en el tratamiento de proctitis ulcerosa activa. ⤷  Try a Trial
South Africa 201204422 MESALAMINE SUPPOSITORY ⤷  Try a Trial
Japan 2012504658 ⤷  Try a Trial
Canada 2690450 SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 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.