Generics Launched for Viagra
December 11, 2017 – Both Teva Pharmaceuticals and Pfizer have launched the first generics for Pfizer’s Viagra® (sildenafil), a phosphodiesterase-5 (PDE-5) inhibitor approved by the U.S. FDA to treat erectile dysfunction (ED).
Although Pfizer’s patent protection for Viagra remains in effect until 2020, a settlement agreement has allowed Teva to launch its generic as of December 11, 2017. Teva has announced a savings card for its generic, as well as assistance for patients in locating pharmacies that carry the product. Individuals who meet the savings card requirements may be able to obtain up to six prescription fills of Teva’s generic sildenafil for as little as $0 out of pocket.
Pfizer’s own generic is priced at an estimated $30 to $35 per pill, compared to an estimated $65 per pill for brand name Viagra. It is manufactured and distributed through Greenstone LLC, a Pfizer subsidiary, and is considered an authorized generic to Viagra. Annual U.S. sales for brand name Viagra were expected to total $1.4 billion in 2017.
Other manufacturers are expected to launch their own generics for Viagra in the United States in mid-2018. Teva also holds settlement agreements that will allow it to launch generics in 2018 for two other ED drugs ahead of patent expiration: Lilly’s Cialis® (tadalafil) and Bayer/GlaxoSmithKline’s Levitra® (vardenafil).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.