Has the Viagra patent expired?

The importance of patent; Viagra patent history and expiration date

Pharmaceutical companies, like the makers of other types of products or consumables, issue new drugs for patients under patents (forms of intellectual property or non-physical property that are the result of creativity), for a limited period of years.  This ensures that the patent-holding company is the only one allowed to manufacture, market, and profit from the drug, until the patent has expired.

 

In May 1994, the pharmaceutical company, Pfizer Inc filed the first patent to cover the use of sildenafil citrate for the treatment of erectile dysfunction (ED) and in 2002, issued the drug under the brand name, Viagra, following approval by the Food and Drug Administration (FDA) on  March 27, 1998. The patent for Viagra was originally scheduled to expire in March 2012. 

 

Pfizer filed a second patent sometimes referred to as a “method-of-treatment patent”, which will expire in 2019.  This led to a case between Teva Pharmaceuticals and Pfizer. In 2013, the companies reached an agreement to allow Teva to bring a generic version of Viagra or generic Viagra to the US market by the end of 2017.  Teva agreed to pay Pfizer royalties for the use of Pfizer’s product (Viagra active ingredient, sildenafil citrate), until its patent expires in 2020.  Royalties are payments made to an owner of a property for the use of that property; in this case, the Viagra patent.   

 

As of March 2016, at least nine other companies filed applications with the FDA to manufacture a generic version of Viagra.  In December 2017, Pfizer released its own generic version of Viagra, as the “little white pill” at half the price of the original Viagra (the little blue pill).

 

In early 2012, Pfizer was given an additional six months of U.S. patent protection for Viagra, relating to the study of the effect of another one of the company’s products containing the active ingredient, sildenafil citrate in children with high blood pressure that affects the arteries in the lungs and right side of the heart (pulmonary hypertension).  This resulted in the extension of Viagra patent to April 2020. 

 

So, although Teva is allowed to make a generic version of Viagra under an agreement with Pfizer; and other companies have filed applications with the FDA to manufacture a generic Viagra, the U.S. patent for Viagra will expire in 2020, when generic companies will be permitted to market their versions of generic Viagra or Sildenafil in the U.S.  However, the patent for Viagra has expired outside the U.S. For example, the patent ended in Europe in June 2013, allowing generic manufacturers to start producing their own version of the active ingredient in Viagra or generic Sildenafil.  

 

References

  1. Eureka, PatSnap Insights: Pfizer's Viagra Patent Expires, [website] 2017 https://www.patsnap.com/blog/patsnap-insights-pfizers-viagra-patent-expires, (accessed September 20, 2019).
  2. Forbes, Viagra: Get Ready For It To Become Generic, Cheaper, And More Available, [website] 2017, https://www.forbes.com/sites/brucelee/2017/12/06/viagra-get-ready-for-it-to-becomes-generic-cheaper-and-more-available/#69d05dee3200, (accessed September 20, 2019).
  3. Everyday Health, Pfizer Launches Generic Viagra, [website] 2017 https://www.everydayhealth.com/erectile-dysfunction/treatment/pfizer-launches-generic-viagra/, (accessed September 20, 2019).
  4. MedicalXpress, Viagra goes generic: Pfizer to launch own little white pill, [website] 2017, https://medicalxpress.com/news/2017-12-viagra-pfizer-white-pill.html, (accessed September 20,  2019).
  5. IPWATCHDOG, What happens when lifestyle drugs like Viagra and Cialis lose patent protections? [website] 2017, https://www.ipwatchdog.com/2017/04/12/lifestyle-drugs-viagra-cialis-lose-patent-protections/id=81619/, (accessed September 19, 2019).
  6. ipeg, VIAGRA EXTENDED PATENT PROTECTION, GENERIC WAIT UNTIL 2020, [website] 2013, https://www.ipeg.com/viagra-extended-patent-protection-generic-wait-until-2020/, (accessed September 19, 2019).

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