Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cerilliant
Federal Trade Commission
Mallinckrodt
Fuji
Express Scripts
McKesson
Healthtrust
US Department of Justice

Generated: November 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022301

« Back to Dashboard

NDA 022301 describes APRISO, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the APRISO profile page.

The generic ingredient in APRISO is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 022301
Tradename:APRISO
Applicant:Valeant Pharms Intl
Ingredient:mesalamine
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 022301
Ingredient-typeAminosalicylic Acids
Medical Subject Heading (MeSH) Categories for 022301
Suppliers and Packaging for NDA: 022301
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-884 43353-884-79 2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79)
APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301 NDA Salix Pharmaceuticals, Inc. 65649-103 65649-103-01 1 BOTTLE in 1 CARTON (65649-103-01) > 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Oct 31, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE AND OLDER
Patent:➤ Sign UpPatent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
Patent:➤ Sign UpPatent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022301

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Sign Up ➤ Sign Up
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Dow
Cerilliant
Harvard Business School
Cantor Fitzgerald
Mallinckrodt
Deloitte
Chubb
Fuji

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 verifification 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.