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.
Summary for LIALDA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 166 |
| Clinical Trials: | 13 |
| Patent Applications: | 5,435 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LIALDA |
| Drug Sales Revenues: | Drug sales revenues for LIALDA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LIALDA |
| What excipients (inactive ingredients) are in LIALDA? | LIALDA excipients list |
| DailyMed Link: | LIALDA at DailyMed |
Recent Clinical Trials for LIALDA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NorthShore University HealthSystem | Phase 2 |
| Food and Drug Administration (FDA) | N/A |
| University of Michigan | N/A |
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 |
Expired US Patents for LIALDA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | LIALDA | mesalamine | TABLET, DELAYED RELEASE;ORAL | 022000-001 | Jan 16, 2007 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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