Exclusivity rights currently prevent any company from making a generic Pertzye product. The earliest predictable date that this could change is March 2017, when the exclusivity rights are set to expire. Although pancrelipase is sometimes called the "generic name" for Pertzye, it is simply the active ingredient in the medication and not a generic version of it.
Can I Buy Generic Pertzye?
Pertzye® (pancrelipase) is a prescription medication approved to treat exocrine pancreatic insufficiency (a deficiency of pancreatic digestive enzymes), such as the type of deficiency that occurs with cystic fibrosis. It comes as delayed-release capsules that are taken by mouth with each meal and snack.
Pertzye is made by Digestive Care, Inc. It is protected from generic competition in the United States by exclusivity rights, which are similar to patents but not exactly the same.
When Will a Generic Version Be Available?
The exclusivity rights for Pertzye are currently set to expire in May 2017. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to delay or shorten this exclusivity period. This could include things such as lawsuits or other patents for new Pertzye uses. Once the exclusivity rights expire, several companies may begin manufacturing a generic Pertzye drug.
Is Pancrelipase a Generic Pertzye?
No -- pancrelipase is the active ingredient in Pertzye, not a generic version of it. What can be confusing is 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.
There are a few other brand-name pancrelipase drugs, but they are not directly interchangeable. Different pancrelipase products have different mixtures of the various enzymes.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Pertzye [package insert]. Bethlehem, PA: Digestive Care, Inc.;2012 May.
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, 2013.
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