.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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

Serving leading biopharmaceutical companies globally:

Julphar
Covington
Cipla
Colorcon
Chubb
Fish and Richardson
Queensland Health
US Army
Fuji
Express Scripts

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021306

« 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 four suppliers. There are four patents protecting this drug and two Paragraph IV challenges. 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. Four suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.

Summary for 021306

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Analgesics
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 Teva Pharmaceuticals USA, Inc. 0093-3600 0093-3600-40 4 POUCH in 1 CARTON (0093-3600-40) > 1 PATCH in 1 POUCH (0093-3600-21) > 168 h in 1 PATCH
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3601 0093-3601-40 4 POUCH in 1 CARTON (0093-3601-40) > 1 PATCH in 1 POUCH (0093-3601-21) > 168 h in 1 PATCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MCG/HR
Approval Date:Jun 30, 2010TE:RLD:Yes
Patent:► SubscribePatent Expiration:Sep 29, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Patent:► SubscribePatent Expiration:Sep 29, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
Patent:► SubscribePatent Expiration:Sep 29, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME

Expired Orange Book Patents for NDA: 021306

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 2013► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010► Subscribe► 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

Serving leading biopharmaceutical companies globally:

Accenture
Medtronic
Cantor Fitzgerald
UBS
Moodys
Queensland Health
Cerilliant
Farmers Insurance
US Department of Justice
Covington

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot