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BUTRANS Drug Profile

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Butrans 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.

This drug has seventy-eight patent family members in twenty-one countries.

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 Tradename: BUTRANS

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: BUTRANS

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010RXYesRE41408► subscribe ► subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 2013RXNoRE41408► subscribe ► subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010RXYes6,264,980► subscribeY ► subscribe
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Expired Patents for Tradename: BUTRANS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 20105,240,711► subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 20106,264,980► subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 20105,240,711► subscribe
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Paragraph IV activity for: BUTRANS

Drugname Dosage Strength RLD Submissiondate
buprenorphineTransdermal System15 mcg/hrButrans12/16/2013
buprenorphineTransdermal System5 mcg/hr, 10 mcg/hr, and 20 mcg/hrButrans6/6/2013

Non-Orange Book Patents for Tradename: BUTRANS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,968,547 Method of providing sustained analgesia with buprenorphine► subscribe
6,344,212 Method of providing sustained analgesia with buprenorphine► subscribe
6,231,886 Methods of providing sustained treatment with opioids► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: BUTRANS

Country Document Number Estimated Expiration
Norway322515► subscribe
Slovenia1570823► subscribe
Slovenia0964677► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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