➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Baxter
AstraZeneca
Merck
McKinsey

Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021306


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021306 describes BUTRANS, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from three suppliers. Additional details are available on the BUTRANS profile page.

The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 021306
Tradename:BUTRANS
Applicant:Purdue Pharma Lp
Ingredient:buprenorphine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021306
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 021306
Suppliers and Packaging for NDA: 021306
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals L.P. 42858-353 42858-353-40 4 POUCH in 1 CARTON (42858-353-40) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals L.P. 42858-493 42858-493-40 4 POUCH in 1 CARTON (42858-493-40) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH
Paragraph IV (Patent) Challenges for 021306
Tradename Dosage Ingredient NDA Submissiondate
BUTRANS FILM, EXTENDED RELEASE;TRANSDERMAL buprenorphine 021306 2013-12-16
BUTRANS FILM, EXTENDED RELEASE;TRANSDERMAL buprenorphine 021306 2013-06-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MCG/HR
Approval Date:Jun 30, 2010TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 13, 2020
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MCG/HR
Approval Date:Jun 30, 2010TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 13, 2020
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength20MCG/HR
Approval Date:Jun 30, 2010TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 13, 2020
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1

Expired US Patents for NDA 021306

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010   Start Trial   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010   Start Trial   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Harvard Business School
Johnson and Johnson
Dow
Express Scripts

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 verification 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.