➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Express Scripts
Merck
AstraZeneca
McKinsey

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022000


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 022000 describes LIALDA, which is a drug marketed by Shire and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the LIALDA profile page.

The generic ingredient in LIALDA is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 022000
Tradename:LIALDA
Applicant:Shire
Ingredient:mesalamine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022000
Medical Subject Heading (MeSH) Categories for 022000
Suppliers and Packaging for NDA: 022000
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000 NDA AUTHORIZED GENERIC Shire US Manufacturing Inc. 54092-100 54092-100-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-100-01)
LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000 NDA Shire US Manufacturing Inc. 54092-476 54092-476-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
Paragraph IV (Patent) Challenges for 022000
Tradename Dosage Ingredient NDA Submissiondate
LIALDA TABLET, DELAYED RELEASE;ORAL mesalamine 022000 2009-12-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength1.2GM
Approval Date:Jan 16, 2007TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 8, 2020Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
McKinsey
Johnson and Johnson
AstraZeneca
Boehringer Ingelheim

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.