There are currently no generic Fentora products available. The first patent for Fentora is set to expire in March 2019, which would be the earliest date a generic product could be available. Although the United States Food and Drug Administration has approved a generic version of Fentora to be manufactured by Watson Laboratories, this approval is pending current litigation.
Can I Buy Generic Fentora?
Fentora® (fentanyl buccal tablets) is a prescription narcotic opioid approved to treat breakthrough pain (sudden bursts of pain that "break through" regularly scheduled pain medication) in people with cancer. It comes in the form of a tablet that is dissolved in the mouth between the cheek and gum or under the tongue.
This medication is a Schedule II controlled substance, which means there are strict laws controlling its use. Like all Schedule II controlled medications, Fentora has a high potential for abuse and addiction.
Fentora is sold by Teva Pharmaceuticals USA, Inc. It is currently under the protection of patents that prevent any generic Fentora from being manufactured in the United States.
When Will a Generic Version Be Available?
It is difficult to determine when a generic version of Fentora will be available. The current patents for Fentora are set to expire in March 2019. Normally, this would be the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period of Fentora. This could include such things as lawsuits or other patents for specific Fentora uses.
In January 2011, the United States Food and Drug Administration (FDA) approved the first generic version of Fentora, made by Watson Laboratories, Inc. However, Cephalon, Inc., filed a lawsuit claiming that the generic drug infringes on the current Fentora patents. Watson Laboratories, Inc., cannot launch their generic version until a decision is made on the lawsuit.
Once Fentora goes completely off-patent, there may be several companies that manufacture a generic Fentora drug.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Fentora [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.;2013 February.
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 January 10, 2010.
Watson Laboratories, Inc Press Release. Watson's Generic Fentora Receives FDA Approval. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1514366. Accessed January 11, 2011.
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