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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)

  • Manufacturer: PURDUE PHARMA LP
    Approval date: June 30, 2010
    Strength(s): 5MCG/HR, 10MCG/HR, 20MCG/HR [RLD]
  • Manufacturer: PURDUE PHARMA LP
    Approval date: July 25, 2013
    Strength(s): 15MCG/HR
  • Manufacturer: PURDUE PHARMA LP
    Approval date: June 30, 2014
    Strength(s): 7.5MCG/HR

Has a generic version of Butrans been approved?

No. There is currently no therapeutically equivalent version of Butrans available in the United States.

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: About generic drugs.

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.

  • Transdermal resorption of active substances from supercooled masses of levulic acid
    Patent 6,264,980
    Issued: July 24, 2001
    Inventor(s): Hille; Thomas
    Assignee(s): LTS Lohmann Therapie-Systeme GmbH
    A pharmaceutical product for the release of medicinal agents to the skin having absorption-increasing auxiliary agents is characterized in that the auxiliary material forms subcooled melts.
    Patent expiration dates:
    • December 18, 2015
      ✓ 
      Drug product
  • Transdermal absorption of active substances from subcooled melts
    Patent 6,344,211
    Issued: February 5, 2002
    Inventor(s): Thomas; Hille
    Assignee(s): LTS Lohmann Therapie-Systeme GmbH
    A pharmaceutical product for the release of medicinal agents to the skin having absorption-increasing auxiliary agents is characterized in that the auxiliary material forms subcooled melts.
    Patent expiration dates:
    • December 18, 2015
      ✓ 
      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.
    • December 18, 2015
      ✓ 
      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 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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