There are currently no generic Astepro products licensed for sale. The manufacturer of the medication holds the exclusive rights to make and market the drug in the United States, which means that no other companies are allowed to produce any generic versions at this time. The earliest possible date that a generic version of the medicine could become available is June 2028.
Is a Generic Version of Astepro Available?
Astepro™ (azelastine hydrochloride) is a prescription nasal spray used to treat seasonal or year-round nasal allergies (known medically as allergic rhinitis). It belongs to a group of medications known as antihistamines. Astepro is a reformulation of a previous medication (Astelin® nasal spray), containing the same active ingredient in the same strength but in a new formulation that has a less bitter taste and causes less nasal discomfort.
Astepro is manufactured by MEDA Pharmaceuticals. At this time, MEDA Pharmaceuticals holds the exclusive rights to make and market this product in the United States. Therefore, there is no generic Astepro at this time.
When Will Generic Astepro Be Available?
The first patent for Astepro is set to expire in June 2028. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to extend the exclusivity period beyond 2028. This could include such things as other patents for specific Astepro uses or lawsuits. Once the medication goes off-patent, there may be several companies that manufacture a generic Astepro drug.
Is Azelastine a Generic Astepro?
The answer is no. Azelastine is the active ingredient in Astepro (as well as a few other medications) but is not a generic version of the medicine. What can be confusing is that, oftentimes, the active ingredient of any 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
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 9, 2012.
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