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Last Updated: September 21, 2021

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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 freedom to operate?

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

Mesalamine has fifty-eight patent family members in twenty-four countries.

There are twenty-eight drug master file entries for mesalamine. Twenty-nine 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
The Swedish Research CouncilPhase 2
Ann-Sofie BackmanPhase 2
Assembly BiosciencesPhase 1

See all mesalamine clinical trials

Generic filers with tentative approvals for MESALAMINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free375MGCAPSULE, 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
Amneal MESALAMINE mesalamine SUPPOSITORY;RECTAL 210509-001 Jan 2, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alkem Labs Ltd MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 214242-001 Jul 15, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Allergan CANASA mesalamine SUPPOSITORY;RECTAL 021252-001 Jan 5, 2001 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Speciality Lp SFROWASA mesalamine ENEMA;RECTAL 019618-002 Jun 20, 2008 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Sun Pharm MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 211858-001 Jan 25, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ⤷  Try it Free ⤷  Try it Free
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try it Free ⤷  Try it Free
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ⤷  Try it Free ⤷  Try it Free
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try it Free ⤷  Try it Free
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Medtronic
Mallinckrodt
Baxter
McKinsey

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.