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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
Boehringer Ingelheim
Teva
Dow
Baxter
Medtronic
Johnson and Johnson
Queensland Health
McKinsey

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021830

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NDA 021830 describes ASACOL HD, which is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASACOL HD profile page.

The generic ingredient in ASACOL HD 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 021830
Tradename:ASACOL HD
Applicant:Apil
Ingredient:mesalamine
Patents:3
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021830
Ingredient-typeAminosalicylic Acids
Medical Subject Heading (MeSH) Categories for 021830
Suppliers and Packaging for NDA: 021830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830 NDA Allergan, Inc. 0023-5901 N 0023-5901-18
ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830 NDA Allergan, Inc. 0430-0783 N 0430-0783-95

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength800MG
Approval Date:May 29, 2008TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ULCERATIVE COLITIS
Patent:➤ Sign UpPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021830

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ➤ Sign Up ➤ Sign Up
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Cipla
Julphar
Merck
Medtronic
Mallinckrodt
Accenture
Queensland Health

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.

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