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Sildenafil manufacturers?

See the DrugPatentWatch profile for Sildenafil

Who manufactures sildenafil?

Sildenafil, the active ingredient in Viagra, is primarily manufactured by a few major pharmaceutical companies. Pfizer, the original developer of Viagra, still holds the majority of the global market share for sildenafil [1]. However, other companies, such as Teva Pharmaceutical Industries, Eli Lilly and Company, and Mylan N.V., have also received FDA approval to manufacture and market their own generic versions of sildenafil [2].

Teva's generic sildenafil

In 2017, Teva Pharmaceutical Industries received FDA approval for its generic version of Viagra (sildenafil citrate tablets) [3]. Teva's generic product is available in 25mg, 50mg, and 100mg strengths and is marketed as a less expensive alternative to the branded version.

Other manufacturers and patents

While Pfizer still holds patents on its branded sildenafil product in many countries, other companies are working to develop their own generic versions. For example, Eli Lilly and Company received FDA approval for its generic sildenafil product in 2018 [4]. Mylan N.V. also received FDA approval for its generic version in 2018 [5].

Regulatory considerations

The manufacturing and marketing of generic sildenafil products are regulated by various government agencies, including the U.S. FDA. Companies must meet strict standards for quality, safety, and efficacy before their products can be approved for sale [6].

Sources

[1] Pfizer. (2022). Viagra (sildenafil citrate). Retrieved from https://www.pfizer.com/news/press-release/list/press-release-detail/viagra-sildenafil-citrate/

[2] U.S. Food and Drug Administration. (2022). Approvals for Sildenafil Products. Retrieved from https://www.fda.gov/drugs/information-drug-class/ approvals-sildenafil-products

[3] Teva Pharmaceutical Industries. (2017). Teva Receives Final FDA Approval for Generic Version of Viagra. Retrieved from https://ir.tevapharm.com/news-releases/news-release-details/teva-receives-final-fda-approval-generic-version-viagra

[4] Eli Lilly and Company. (2018). Lilly Receives FDA Approval for Generic Version of Viagra. Retrieved from https://investor.lilly.com/news-events/press-releases/detail/1114

[5] Mylan N.V. (2018). Mylan Receives FDA Approval for Generic Version of Viagra. Retrieved from https://newsroom.mylnx.com/mylan-receives-fda-approval-for-generic-version-of-viagra

[6] U.S. Food and Drug Administration. (2022). Generic Drugs and Biosimilars. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-and-biosimilars

Sources

1. Pfizer. (2022). Viagra (sildenafil citrate).
2. U.S. Food and Drug Administration. (2022). Approvals for Sildenafil Products.
3. Teva Pharmaceutical Industries. (2017). Teva Receives Final FDA Approval for Generic Version of Viagra.
4. Eli Lilly and Company. (2018). Lilly Receives FDA Approval for Generic Version of Viagra.
5. Mylan N.V. (2018). Mylan Receives FDA Approval for Generic Version of Viagra.
6. U.S. Food and Drug Administration. (2022). Generic Drugs and Biosimilars.



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