At this time, generic Macugen is not available in the United States. Although the first patents for Macugen have expired, no generic versions have come to market. The next patent is set to expire in 2015, after which it is predicted that a generic product could become available.
Generic Macugen: An Overview
Macugen® (pegaptanib sodium) is a prescription medication used to treat age-related macular degeneration. Specifically, it is used to treat "wet" macular degeneration, a less common but more damaging form of the disease (as opposed to "dry" macular degeneration).
Macugen is made jointly by Eyetech, Inc. and Pfizer. It is currently under the protection of a patent that prevents any generic Macugen from being manufactured in the United States.
When Will Generic Macugen Be Available?
The first patents for Macugen expired in June 2010 and October 2013, and there are still no generic versions of this medication. This suggests that other patents, set to expire later, provide significant protection against generic competition.
The next patent for Macugen is currently set to expire in May 2015. This is now the earliest predicted date that a generic version of the drug could become available.
However, other circumstances could come up to extend the exclusivity period beyond 2015. This could include such things as other patents for specific Macugen uses or lawsuits. Once the patent expires, several companies may begin manufacturing generic Macugen.
Is Pegaptanib the Same as Generic Macugen?
No -- pegaptanib is the active ingredient in Macugen, but is not a generic version of it. What can be confusing is that oftentimes, the active ingredient of a drug is 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 of a medicine, 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Macugen [package insert]. New York, NY: Pfizer, Inc.;2006 July.
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 December 3, 2013.
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