.

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): 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 three suppliers. There are five 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-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.

Summary for NDA: 021306

Tradename:
BUTRANS
Applicant:
Purdue Pharma Lp
Ingredient:
buprenorphine
Patents:5
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021306

Mechanism of ActionPartial Opioid Agonists

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 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-605 35356-605-04 4 POUCH in 1 CARTON (35356-605-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-606 35356-606-04 4 POUCH in 1 CARTON (35356-606-04) > 1 PATCH in 1 POUCH > 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:No
Patent:6,264,980Patent Expiration:Dec 18, 2015Product Flag?YSubstance Flag?Delist Request?
Patent:6,344,211Patent Expiration:Dec 18, 2015Product 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:RE41408Patent 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.

Expired Orange Book Patents for NDA: 021306

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 20146,264,980► subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 20136,264,980► subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 20146,344,211► 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