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Generic Butrans Availability

Butrans is a brand name of buprenorphine, approved by the FDA in the following formulation(s):

BUTRANS (buprenorphine - film, extended release;transdermal)

Has a generic version of Butrans been approved?

An Authorized Generic version of Butrans has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.

List of authorized generic versions:

  • Buprenorphine TRANSDERMAL PATCH, EXTENDED RELEASE 5 ug/h
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933600
  • Buprenorphine TRANSDERMAL PATCH, EXTENDED RELEASE 10 ug/h
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933601
  • Buprenorphine TRANSDERMAL PATCH, EXTENDED RELEASE 15 ug/h
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933602
  • Buprenorphine TRANSDERMAL PATCH, EXTENDED RELEASE 20 ug/h
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000933603
  • Buprenorphine TRANSDERMAL PATCH 7.5 ug/h
    Rhodes Pharmaceuticals L.P.
    NDC Code: 428580353
  • Buprenorphine TRANSDERMAL PATCH 10 ug/h
    Rhodes Pharmaceuticals L.P.
    NDC Code: 428580493
  • Buprenorphine TRANSDERMAL PATCH 15 ug/h
    Rhodes Pharmaceuticals L.P.
    NDC Code: 428580586
  • Buprenorphine TRANSDERMAL PATCH 5 ug/h
    Rhodes Pharmaceuticals L.P.
    NDC Code: 428580750
  • Buprenorphine TRANSDERMAL PATCH 20 ug/h
    Rhodes Pharmaceuticals L.P.
    NDC Code: 428580839

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Butrans. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Method of providing sustained analgesia with buprenorphine
    Patent 9,642,850
    Issued: May 9, 2017
    Assignee(s): PURDUE PHARMA L.P.
    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.
    Patent expiration dates:
    • September 29, 2017
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
  • Method of providing sustained analgesia with buprenorpine
    Patent RE41408
    Issued: June 29, 2010
    Inventor(s): Reder; Robert F. & Kaiko; Robert F. & Goldenheim; Paul D.
    Assignee(s): Purdue Pharma L.P.
    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 addition 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.
    Patent expiration dates:
    • September 29, 2017
      ✓ 
      Patent 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
    • September 29, 2017
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
  • Method of providing sustained analgesia with buprenorphine
    Patent RE41489
    Issued: August 10, 2010
    Inventor(s): Reder; Robert F. & Kaiko; Robert F. & Goldenheim; Paul D.
    Assignee(s): Purdue Pharma L.P.
    A method of effectively treating pain in humans is achieved by administering buprenorphinein 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.
    Patent expiration dates:
    • September 29, 2017
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
    • September 29, 2017
      ✓ 
      Patent 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
  • Method of providing sustained analgesia with buprenorphine
    Patent RE41571
    Issued: August 24, 2010
    Inventor(s): Reder; Robert F. & Kaiko; Robert F. & Goldenheim; Paul D.
    Assignee(s): Purdue Pharma L.P.
    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.
    Patent expiration dates:
    • September 29, 2017
      ✓ 
      Patent use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
    • September 29, 2017
      ✓ 
      Patent 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
Glossary
TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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