Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Chubb
Dow
Johnson and Johnson
Citi
Farmers Insurance
Merck
McKinsey

Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021513

« Back to Dashboard

NDA 021513 describes ENABLEX, which is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. Additional details are available on the ENABLEX profile page.

The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 021513
Tradename:ENABLEX
Applicant:Apil
Ingredient:darifenacin hydrobromide
Patents:0
Pharmacology for NDA: 021513
Suppliers and Packaging for NDA: 021513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513 NDA Allergan, Inc. 0430-0170 0430-0170-00 337500 TABLET, EXTENDED RELEASE in 1 DRUM (0430-0170-00)
ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513 NDA Allergan, Inc. 0430-0170 0430-0170-15 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0430-0170-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 7.5MG BASE
Approval Date:Dec 22, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Dec 22, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021513

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ➤ Sign Up ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ➤ Sign Up ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ➤ Sign Up ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ➤ 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:

Argus Health
Daiichi Sankyo
Medtronic
Deloitte
Cerilliant
Boehringer Ingelheim
Cantor Fitzgerald
Queensland Health
Johnson and Johnson

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.