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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for Patent: RE41571

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Which drugs does patent RE41571 protect, and when does it expire?


Patent RE41571 protects BUTRANS and is included in one NDA. There have been two Paragraph IV challenges on Butrans.

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

Summary for Patent: RE41571

Title:Method of providing sustained analgesia with buprenorphine
Abstract:A method of effectively treating pain in humans is achieved by administering buprenorphine in accordance with first order kinetics over an initial three-day dosing interval, such that a maximum plasma concentration from about 20 pg/ml to about 1052 pg/ml is attained, and thereafter maintaining the administration of buprenorphine for at least an additional two-day dosing interval in accordance with substantially zero order kinetics, such that the patients experience analgesia throughout the at least two-day additional dosing interval.
Inventor(s): Reder; Robert F. (Greenwich, CT), Kaiko; Robert F. (Weston, CT), Goldenheim; Paul D. (Wilson, CT)
Assignee: Purdue Pharma L.P. (Stamford, CT)
Application Number:11/799,610
Patent Claim Types:
see list of patent claims
Use; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010RXYesNo► Subscribe► SubscribeTHE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-001Jun 30, 2010RXYesNo► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014RXYesNo► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-005Jun 30, 2014RXYesNo► Subscribe► SubscribeTHE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 2010RXYesNo► Subscribe► SubscribeTHE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 2010RXYesNo► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 2013RXYesNo► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-004Jul 25, 2013RXYesNo► Subscribe► SubscribeTHE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010RXYesYes► Subscribe► SubscribeMANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.► Subscribe
Purdue Pharma LpBUTRANSbuprenorphineFILM, EXTENDED RELEASE;TRANSDERMAL021306-003Jun 30, 2010RXYesYes► Subscribe► SubscribeTHE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME► Subscribe
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Non-Orange Book Patents for Patent: RE41571

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
RE41489Method of providing sustained analgesia with buprenorphine► Subscribe
9,642,850Method of providing sustained analgesia with buprenorphine► Subscribe
RE41408Method of providing sustained analgesia with buprenorpine► 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 Patent: RE41571

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria336212► Subscribe
Austria538765► Subscribe
Austria556682► Subscribe
Australia2004218685► Subscribe
Australia2008261134► Subscribe
Australia2012244363► Subscribe
Australia2013204227► Subscribe
Australia2925402► Subscribe
Australia6184198► Subscribe
Australia743071► 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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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Accenture
Colorcon
Harvard Business School
Dow
AstraZeneca
Cipla
McKesson
Chinese Patent Office
Mallinckrodt

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