LIALDA Drug Patent Profile
✉ Email this page to a colleague
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 |