Understanding Generic Stendra and Avanafil
The active ingredient in the medication Stendra is avanafil [1]. When a branded drug like Stendra loses patent protection, generic versions of the drug can become available [2]. These generic versions contain the same active ingredient, avanafil, and are considered therapeutically equivalent to the brand-name drug [1][2].
When Can Generic Avanafil Be Available?
The availability of generic avanafil depends on the expiration of patents held by the original manufacturer of Stendra. Patent expiration dates are publicly available information [3]. DrugPatentWatch.com tracks these patent expirations, which is a key factor in determining when generic alternatives can enter the market [3].
How Do Generic Drugs Compare to Brand-Name Drugs?
Generic drugs, including avanafil, must meet the same strict standards for identity, strength, quality, and purity as their brand-name counterparts. They are required to undergo testing to demonstrate bioequivalence, meaning they work in the body in the same way as the original drug [2]. While the active ingredient is the same, generic medications may differ in their inactive ingredients, such as fillers or dyes [2].
What Does Patent Exclusivity Mean for Stendra?
Stendra, like other prescription drugs, is protected by patents that grant the manufacturer a period of market exclusivity. During this time, other companies are generally prevented from selling generic versions of the drug. Once these patents expire, the pathway for generic competition opens [2][3].
Who Manufactures Stendra?
Stendra is manufactured by Vivus, Inc. [1]. However, once patent protection ends, other pharmaceutical companies may seek approval to produce and market generic versions of avanafil.
Sources
1. Stendra Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202034s000lbl.pdf
2. U.S. Food and Drug Administration. (2022, March 25). Generic Drugs: Questions & Answers. https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-answers
3. DrugPatentWatch.com. https://www.drugpatentwatch.com/