Why generic Viagra will have to wait

March 14, 2016

While FDA just approved the first generic version of sildenafil citrate (Viagra, Pfizer), the new product won’t be on the market until late 2017.

While FDA just approved the first generic version of sildenafil citrate (Viagra, Pfizer), the new product won’t be on the market until late 2017.

Teva Pharmaceuticals received approval to market generic sildenafil citrate tablets in 25 mg, 50 mg, and 100 mg strengths and has 180-day exclusivity

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However, because Teva has a pay-for-delay settlement with Pfizer, it will not launch the generic Viagra until December, 2017. Generic manufacturer Mylan Pharmaceuticals also signed an agreement with Pfizer to not market its generic Viagra until December, 2017.

Meanwhile, Teva has already been selling its generic Viagra in Europe since 2013.

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At least 9 other generic manufacturers have filed abbreviated new drug applications with FDA seeking approval for their versions of generic Viagra, according to Regulatory Focus.

Meanwhile, FDA said patients taking sildenafil citrate should talk to their doctor or pharmacist if they have heart problems, stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, a severe loss of body water, history of painful/prolonged erection, conditions that may increase the risk of painful/prolonged erection (such as sickle cell anemia, leukemia, multiple myeloma), and eye problems.

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