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Last Updated: May 27, 2022

LIALDA Drug Patent Profile


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When do Lialda patents expire, and when can generic versions of Lialda launch?

Lialda is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in LIALDA is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lialda

A generic version of LIALDA was approved as mesalamine by PADAGIS ISRAEL on September 17th, 2004.

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Drug patent expirations by year for LIALDA
Drug Prices for LIALDA

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Drug Sales Revenue Trends for LIALDA

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Recent Clinical Trials for LIALDA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NorthShore University HealthSystemPhase 2
Food and Drug Administration (FDA)N/A
University of MichiganN/A

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Paragraph IV (Patent) Challenges for LIALDA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LIALDA Delayed-release Tablets mesalamine 1.2 g 022000 1 2009-12-16

US Patents and Regulatory Information for LIALDA

LIALDA is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting LIALDA

NEW PATIENT POPULATION
Exclusivity Expiration: 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
Takeda Pharms Usa LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000-001 Jan 16, 2007 AB RX Yes Yes 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

International Patents for LIALDA

See the table below for patents covering LIALDA around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1046247 See Plans and Pricing
Hong Kong 1085669 See Plans and Pricing
Japan 5235839 See Plans and Pricing
European Patent Office 1198226 COMPOSITIONS PHARMACEUTIQUES ORALES A LIBERATION REGULEE A BASE DE MESALAZINE (MESALAZINE CONTROLLED RELEASE ORAL PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
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Baxter
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McKinsey

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