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Last Updated: March 19, 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
Zydus Pharms MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203286-001 Jul 21, 2017 RX No Yes ⤷  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
Teva Pharms Usa MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 209970-001 May 6, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 214585-001 May 11, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie CANASA mesalamine SUPPOSITORY;RECTAL 021252-001 Jan 5, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 207271-001 Nov 20, 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
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Abbvie DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  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
Canada 2690450 SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY) ⤷  Try a Trial
Eurasian Patent Organization 201100565 КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ КИШЕЧНИКА С ИСПОЛЬЗОВАНИЕМ ГРАНУЛИРОВАННОГО МЕЗАЛАМИНА ⤷  Try a Trial
New Zealand 578674 REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD) ⤷  Try a Trial
Spain 2567068 ⤷  Try a Trial
Mexico 2012006902 SUPOSITORIO DE MESALAMINA. (MESALAMINE SUPPOSITORY.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008094618 ⤷  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.