Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Teva Pharmaceutical Industries is launching a generic form of Viagra, a popular drug used for erectile dysfunction (ED). The press release announced that the generic version would be made available on December 11, 2017.
This new generic Viagra, simply referred to as "sildenafil tablets" on Teva's website, will be available in the same doses as Viagra at approximately half the cost. Teva has also mentioned offering additional savings to eligible patients.
Until June 9, 2018, Teva has been granted exclusivity by the FDA over manufacturing of this new generic Viagra. After that point in time, other companies will be allowed to manufacture and market their own generic versions of Viagra.
While Pfizer Inc., the original manufacturer of Viagra, once dominated the ED drug market, their sales have slowly declined as more ED drugs have become available such as Levitra and Cialis, manufactured by GlaxoSmithKline and Eli Lilly and Company, respectively. Teva's generic Viagra further threatens Pfizer's revenue.
In hopes of clinging to as much of the market as possible, Pfizer has also decided to sell an "authorized generic" version of its drug. A recent MedScape article provides more information:
New York–based Pfizer will start selling what's known as an "authorized generic," manufactured by its subsidiary Greenstone LLC, priced at $30 to $35 per pill, a company spokesman told Medscape Medical News. That's roughly half or less of the $65-a-pill cost for Viagra seen on pharmacy websites.
The manufacturer of this authorized generic Viagra, Greenstone, recently released its Product Fact Sheet, which provides information on dose availability and other technical information for the new generic ED drug.
However, generic Viagra isn't the only cost-effective alternative to traditional Viagra treatment of ED. Revatio is another drug manufactured by Pfizer that can be used to treat ED, and it has the same active ingredient as Viagra (sildenafil). The only difference between Revatio and Viagra is the dosage amount: Viagra is available in 25, 50, or 100mg doses, while Revatio is typically available in 5mg or 20mg doses. Revatio has also been available in generic form for several years.
While a cheaper, generic version of Viagra will be good news for those who couldn't afford the brand-name drug, it is important to keep in mind the adverse side effects of these drugs, often referred to as phosphodiesterase type 5 (PDE5) inhibitors.
The drug label for Teva's sildenafil tablets (revised 8/2017, accessed 12/11/17) warns against a type of sudden vision loss called Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). To read more about this side effect, see Attorney Tom Lamb's recent blog post.
Not included, however, is the serious side effect of melanoma skin cancer. Many lawsuits have already been filed concerning patients who have been diagnosed with melanoma after using Viagra and Cialis.
Here are several recent articles written by our firm on the association of ED drugs with melanoma:
- 11/1/17 - 2017 Medical Articles: Association Of Melanoma With Viagra And Cialis
- 5/30/17 - New Study Suggests Erectile Dysfunction Drugs May Not Cause Melanoma
- 10/19/16 - Viagra – Melanoma MDL Might Include Cialis Lawsuits And Levitra Cases
Effects on Lawsuits
While the Supreme Court's ruling in Pliva, Inc., et al. v. Mensing typically protects manufacturers of generic drugs from any "failure to warn" lawsuits, this new generic form of Viagra may not fall under the umbrella of that ruling.
Given that Pfizer is the original manufacturer of Viagra and its subsidiary, Greenstone, will be manufacturing their new authorized generic version of the drug, it may still be vulnerable to lawsuits brought forth by users of the generic Viagra.
However, the same exception may not apply to Teva's generic version of Viagra.
We will continue to monitor the medical literature concerning ED drugs -- also referred to as PDE5 inhibitors -- and an increased risk of melanoma skin cancer and other serious side effects.
In the meantime, we encourage you to visit our website to learn more, and complete a free case evaluation if you or someone you know has been diagnosed with melanoma or sudden vision loss after using Viagra, Cialis, or some other ED drug.
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