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LIALDA Drug Profile
» See Plans and Pricing
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. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-one patent family members in seventeen countries.
The generic ingredient in LIALDA is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
US ANDA Litigation and Generic Entry Outlook for Lialda
A generic version of LIALDA was approved as mesalamine by PERRIGO ISRAEL on September 17th, 2004.
Summary for LIALDA
| International Patents: | 31 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 160 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,032 |
| 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 |
| Shire | Phase 1 |
| Shire Human Genetic Therapies, Inc. | Phase 3 |
Pharmacology for LIALDA
| Drug Class | Aminosalicylate |
Paragraph IV (Patent) Challenges for LIALDA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LIALDA | TABLET, DELAYED RELEASE;ORAL | mesalamine | 022000 | 2009-12-16 |
US Patents and Regulatory Information for LIALDA
| 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 | Start Trial | Start Trial | Y | Start Trial | ||
| Takeda Pharms Usa | LIALDA | mesalamine | TABLET, DELAYED RELEASE;ORAL | 022000-001 | Jan 16, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LIALDA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1085669 | Start Trial |
| Germany | 60001835 | Start Trial |
| Hong Kong | 1046247 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0076481 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
