Butrans is a drug owned by Knoa Pharma Llc. It is protected by 6 US drug patents filed from 2013 to 2017 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 13, 2020. Details of Butrans's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE41571 | Method of providing sustained analgesia with buprenorphine |
Sep, 2017
(9 years ago) |
Expired
|
| USRE41489 | Method of providing sustained analgesia with buprenorphine |
Sep, 2017
(9 years ago) |
Expired
|
| USRE41408 | Method of providing sustained analgesia with buprenorpine |
Sep, 2017
(9 years ago) |
Expired
|
| US9642850 | Method of providing sustained analgesia with buprenorphine |
Sep, 2017
(9 years ago) |
Expired
|
| US6264980 | Transdermal resorption of active substances from supercooled masses of levulic acid |
Dec, 2015
(10 years ago) |
Expired
|
| US6344211 | Transdermal absorption of active substances from subcooled melts |
Dec, 2015
(10 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Butrans's patents.
Latest Legal Activities on Butrans's Patents
Given below is the list of recent legal activities going on the following patents of Butrans.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 14 Jun, 2021 | US9642850 |
| Maintenance Fee Reminder Mailed
Critical | 28 Dec, 2020 | US9642850 |
| Patent Issue Date Used in PTA Calculation
Critical | 09 May, 2017 | US9642850 |
| Recordation of Patent Grant Mailed
Critical | 09 May, 2017 | US9642850 |
| Issue Notification Mailed
Critical | 19 Apr, 2017 | US9642850 |
| Dispatch to FDC | 06 Apr, 2017 | US9642850 |
| Application Is Considered Ready for Issue
Critical | 22 Mar, 2017 | US9642850 |
| Issue Fee Payment Verified
Critical | 20 Mar, 2017 | US9642850 |
| Issue Fee Payment Received
Critical | 20 Mar, 2017 | US9642850 |
| Printer Rush- No mailing | 09 Mar, 2017 | US9642850 |
FDA has granted several exclusivities to Butrans. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Butrans, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Butrans.
Exclusivity Information
Butrans holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Butrans's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 30, 2013 |
| M(M-250) | Oct 13, 2020 |
US patents provide insights into the exclusivity only within the United States, but
Butrans is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Butrans's family patents as well as insights into
ongoing legal events
on those patents.
Butrans's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Butrans:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Butrans's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 13, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Butrans Generic API suppliers:
Buprenorphine is the generic name for the brand Butrans. 5 different companies have already filed for the generic of Butrans, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Butrans's generic
How can I launch a generic of Butrans before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Butrans's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Butrans's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Butrans -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 16 Dec, 2013 | 29 Sep, 2017 | Extinguished | 20 Nov, 2018 | Less | |
| 06 Jun, 2013 | 29 Sep, 2017 | Extinguished | 20 Nov, 2018 | Less |
Alternative Brands for Butrans
Butrans which is used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy., has several other brand drugs in the same treatment category and using the same active ingredient (Buprenorphine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Bdsi |
| |||||
| Collegium Pharm Inc |
| |||||
| Knoa Pharma |
| |||||
| Purdue Pharma Lp |
| |||||
| Zyla |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Buprenorphine. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Bdsi |
| ||
| Braeburn |
| ||
| Edenbridge Pharms |
| ||
| Indivior |
| ||
| Reacx Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine, Butrans's active ingredient. Check the complete list of approved generic manufacturers for Butrans
About Butrans
Butrans is a drug owned by Knoa Pharma Llc. It is used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy. Butrans uses Buprenorphine as an active ingredient. Butrans was launched by Knoa in 2010.
Approval Date:
Butrans was approved by FDA for market use on 30 June, 2010.
Active Ingredient:
Butrans uses Buprenorphine as the active ingredient. Check out other Drugs and Companies using Buprenorphine ingredient
Treatment:
Butrans is used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy.
Dosage:
Butrans is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MCG/HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 15MCG/HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 10MCG/HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 7.5MCG/HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 5MCG/HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |