Actonel (risedronate sodium) is currently protected from generic competition by a patent that is set to expire in June 2014. This is the earliest predictable date a generic could become available, although other circumstances (such as lawsuits) could delay this. So-called generic versions may be available on the Internet, but the safety of these drugs is questionable.
Generic Actonel: An Overview
Actonel® (risedronate sodium) is a prescription medication used to treat both Paget's disease and osteoporosis. It is part of a group of medications known as bisphosphonates.
Actonel is made by Warner Chilcott Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Actonel from being manufactured in the United States. Yet if you search the Internet for "generic Actonel," you may find a number of companies selling it. The fact is that these medicines may be fake, substandard, and potentially dangerous. Generic Actonel may be available from another country, but there is really no way of knowing if you are getting genuine Actonel or not. You should not buy any so-called generic Actonel until an approved version is available.
When Will Generic Actonel Be Available?
There have already been a few patent battles in the courts about the possibility of generic Actonel. A U.S. district court has ruled that a particular Actonel patent set to expire in June 2014 is valid and provides protection against generic competition. As a result, June 2014 is the earliest predictable date that a generic version of the drug could become available.
However, other circumstances could come up to extend or shorten the exclusivity period. This includes such things as other patents for specific Actonel uses or lawsuits. Once the patent expires, several companies will likely begin manufacturing generic Actonel.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Actonel [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC;2011 January.
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 March 25, 2013.
Procter & Gamble. Procter & Gamble wins patent infringement lawsuit for osteoporosis therapy Actonel (May 13, 2009). P&G Web site. Available at: http://news.pg.com/press-release/pg-corporate-announcements/procter-gamble-wins-patent-infringement-lawsuit-osteoporosi. Accessed March 25, 2013.
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