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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Covington
Baxter
Farmers Insurance
Chubb
Colorcon
McKesson
Chinese Patent Office
Merck

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022301

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NDA 022301 describes APRISO, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from three 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 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
Therapeutic Class:Inflammatory Bowel Disease Agents
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 N 43353-884-79
APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301 NDA Physicians Total Care, Inc. 54868-6150 E 54868-6150-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Oct 31, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
Patent:➤ Try a Free TrialPatent 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 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Merck
Cerilliant
Fish and Richardson
Cantor Fitzgerald
Julphar
Covington
Colorcon

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