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Last Updated: August 8, 2020

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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, Mylan, Shire, G And W Labs Inc, Perrigo Israel, Mylan Speciality Lp, Allergan, Amneal Pharms Llc, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Zydus Pharms, Meda Pharms, Actavis Labs Fl, and Sun Pharm, and is included in twenty-five NDAs. There are nine patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has ninety-six patent family members in twenty-eight countries.

There are twenty-eight drug master file entries for mesalamine. Twenty-six suppliers are listed for this compound. There is one tentative approval 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
AllerganPhase 1
Assembly BiosciencesPhase 1
Colitis & Crohn's Foundation (India)Phase 3

See all MESALAMINE clinical trials

Generic filers with tentative approvals for MESALAMINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial375MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MESALAMINE
Drug ClassAminosalicylate
Medical Subject Heading (MeSH) Categories for MESALAMINE
Paragraph IV (Patent) Challenges for MESALAMINE
Tradename Dosage Ingredient NDA Submissiondate
DELZICOL CAPSULE, DELAYED RELEASE;ORAL mesalamine 204412 2014-06-17
CANASA SUPPOSITORY;RECTAL mesalamine 021252 2013-05-24
APRISO CAPSULE, EXTENDED RELEASE;ORAL mesalamine 022301 2012-04-03
ASACOL HD TABLET, DELAYED RELEASE;ORAL mesalamine 021830 2011-07-13
LIALDA TABLET, DELAYED RELEASE;ORAL mesalamine 022000 2009-12-16
ASACOL TABLET, DELAYED RELEASE;ORAL mesalamine 019651 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
Allergan CANASA mesalamine SUPPOSITORY;RECTAL 021252-002 Nov 5, 2004 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amring Pharms MESALAMINE mesalamine SUPPOSITORY;RECTAL 208362-001 Jun 21, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp SFROWASA mesalamine ENEMA;RECTAL 019618-002 Jun 20, 2008 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-002 Jul 8, 2004 RX Yes Yes   Start Trial   Start Trial   Start Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203574-001 Nov 20, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 DISCN No No   Start Trial   Start Trial   Start 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
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992   Start Trial   Start Trial
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987   Start Trial   Start Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008   Start Trial   Start Trial
Shire LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000-001 Jan 16, 2007   Start Trial   Start Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013   Start Trial   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008   Start Trial   Start Trial
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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