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Last Updated: August 3, 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 patent protection?

Mesalamine is the generic ingredient in ten branded drugs marketed by Apil, Teva Pharms Usa, Valeant Pharms Intl, 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-six 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-eight 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
Ann-Sofie BackmanPhase 2
The Swedish Research CouncilPhase 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
Zydus Pharms MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 091640-001 Jun 5, 2017 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
Meda Pharms ROWASA mesalamine SUPPOSITORY;RECTAL 019919-001 Dec 18, 1990 DISCN Yes 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
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
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:

Boehringer Ingelheim
McKesson
Medtronic
Baxter
Dow
Merck

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