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Last Updated: December 7, 2022

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 Apil, Teva Pharms Usa, Valeant Pharms Intl, Alembic Pharms Ltd, Alkem Labs Ltd, Mylan, Sun Pharm, Zydus Pharms, Takeda Pharms Usa, G And W Labs Inc, Padagis Israel, Mylan Speciality Lp, Allergan, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Meda Pharms, and Actavis Labs Fl, and is included in thirty-one 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-seven patent family members in eighteen countries.

There are twenty-eight drug master file entries for mesalamine. Thirty-three 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
Tanta UniversityPhase 2
AbbViePhase 3
Icahn School of Medicine at Mount SinaiPhase 1/Phase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal MESALAMINE mesalamine SUPPOSITORY;RECTAL 210509-001 Jan 2, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
G And W Labs Inc MESALAMINE mesalamine ENEMA;RECTAL 076841-001 Sep 30, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 208954-001 Aug 12, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 214585-001 May 11, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Takeda Pharms Usa PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 See Plans and Pricing See Plans and Pricing
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 See Plans and Pricing See Plans and Pricing
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 See Plans and Pricing See Plans and Pricing
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 See Plans and Pricing See Plans and Pricing
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for mesalamine

Country Patent Number Title Estimated Expiration
Israel 212057 שימוש בתכשירים המכילים מזלאמין מגורען לשימור ההפוגה בקוליטיס כיבית (Use of compositions comprising granulated mesalamine for maintaining the remission of ulcerative colitis) See Plans and Pricing
European Patent Office 2334178 COMPOSITIONS ET PROCÉDÉS PERMETTANT DE TRAITER LES MALADIES INTESTINALES À L AIDE DE MÉSALAMINE GRANULÉE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE) See Plans and Pricing
Mexico 2011003595 COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES INTESTINALES CON MESALAMINA GRANULADA. (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE.) See Plans and Pricing
South Africa 201204422 MESALAMINE SUPPOSITORY See Plans and Pricing
Canada 2739465 COMPOSITIONS ET PROCEDES PERMETTANT DE TRAITER LES MALADIES INTESTINALES A L'AIDE DE MESALAMINE GRANULEE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE) See Plans and Pricing
Japan 2013514979 See Plans and Pricing
>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.