There are currently no generic Butrans (buprenorphine patch) products available in the United States. Although the first patent for Butrans expired in November 2010, it is likely that other patents prevent manufacturers from making a generic version. The next patent is set to expire in December 2015, which would be the earliest date a generic product could become available.
Can I Buy Generic Butrans?
Butrans® (buprenorphine patch) is a long-acting prescription pain medication approved to treat moderate-to-severe, persistent, and chronic pain. It comes in the form of a patch that is applied just once a week.
Butrans is a Schedule III controlled substance because it has the potential for abuse. There are strict laws and regulations controlling its use.
Butrans is manufactured by LTS Lohmann Therapie-Systeme AG for Purdue Pharma, L.P. In the United States, there are no generic versions of Butrans available at this time.
When Will a Generic Version Be Available?
The first listed patent for Butrans expired in November 2010. However, because Butrans was not even commercially available until early 2011, it is likely that other, later expiring patents provide protection against generic competition.
The next listed patent is currently set to expire in December 2015. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Butrans uses. Once this patent expires, there may be several companies that manufacture a generic Butrans drug.
Is Buprenorphine a Generic Butrans?
No -- buprenorphine is the active ingredient in Butrans (as well as in several other drugs), but is not a generic version of it. What can be confusing is that the active ingredient of a drug is often referred to as the "generic name."
The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed February 15, 2011.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click