.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019651

« Back to Dashboard
NDA 019651 describes ASACOL, which is a drug marketed by Apil and is included in two NDAs. It is available from six suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ASACOL profile page.

The generic ingredient in ASACOL is mesalamine. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 019651

Tradename:
ASACOL
Applicant:
Apil
Ingredient:
mesalamine
Patents:0
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019651

Ingredient-typeAminosalicylic Acids

Suppliers and Packaging for NDA: 019651

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL 019651 NDA KAISER FOUNDATION HOSPITALS 0179-0111 0179-0111-70 30 TABLET, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0179-0111-70)
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL 019651 NDA Warner Chilcott (US), LLC 0430-0752 0430-0752-00 67507 TABLET, DELAYED RELEASE in 1 DRUM (0430-0752-00)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength400MG
Approval Date:Jan 31, 1992TE:RLD:No

Expired Orange Book Patents for NDA: 019651

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,170► subscribe
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,171► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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.

`abc