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The Major Pharmaceuticals Losing Patent Protection in 2016


Click here to see our updated infographic on the pharmaceuticals losing patent protection in 2017.

2016 is going to be a big year. We’ll elect a new president, see our best athletes head to the summer Olympics in Rio de Janeiro and celebrate a leap year. However, 2016 is also a year to watch in the pharmaceutical industry. Several highly profitable drugs are going off-patent in 2016, losing the protection of the company that has held all rights to the drug – and ensuring that it won’t be long until cheaper generic alternatives hit the shelves.

The pharmaceuticals losing patent protection in 2016


What exactly does going off-patent mean? When a pharmaceutical company develops and “brands” a drug, it’s held under patent protection. Only the pharmaceutical company that holds the patent is allowed to manufacture, market and sell the drug. Patents in the United States usually run about 20 years, but patents are applied for well before the clinical trial begins, so the shelf life of a patent in the United States usually is about seven to 12 years.

What Happens When Patents Expire?

Manufacturers desiring to sell the now-generic version of a drug that has gone off-patent do not need to prove the safety and efficacy of the drug since that has already been done. Instead, they submit a New Drug Application (ANDA) to the Food and Drug Administration (FDA) intended to demonstrate that the proposed generic is the same as the previously approved drug. While it is commonly believed that the FDA’s drug approval process is slower than its foreign competitors, it is often faster and more willing to approve certain drugs. Seventy-five percent of the new drugs approved by both the FDA and European Medicines Agency (EMA) between 2006 and 2010 were first approved in the United States, while the FDA approved 32 of 35 prospective cancer drugs from 2003-2010. The EMA approved only 26.

What’s at Stake?

At Dickson, we’re all about data, and when it comes to intellectual property in the pharmaceutical industry, the numbers are staggering.

  • Estimates vary on how much it costs to bring a new drug to market, but a recent study from the Tufts Center for the Study of Drug Development (CSDD) pegs the average total at $2.9 billion. However, 95 percent of medicines fail during development, and only two in 10 recoup their research and development costs.
  • Once drugs lose patent protection, generics siphon off up to 90 percent of sales.
  • The average annual savings from switching to generic medications is estimated to be $420 per consumer.

Because of the high cost of research and development, pharmaceutical companies advocate for strong patent protection. The US is an outlier, however, with patent duration coming under scrutiny during the recent Trans Pacific Partnership (TPP) negotiations.

Who Stands to Lose Out?

AstraZeneca is one company in 2016 that is losing two major drugs from patent protection—Cestor and Seroquel XR—worth a combined annual revenue $7.34 billion. The top five biggest patent losses in 2016 per holder after AstraZeneca are Daiichi Sankyo, Merck, Abbott and ViiV.

Of course, there’s room here for consumers to gain. Four major HIV drugs also are going off-patent in 2016: Epzicom, Trizivir, Norvir and Kaletra, with a current cost-per-pill at $39.57, $11.07, $8.83 and $7.22, respectively. The good news? Costs for generics are 80 to 85% lower on average than those of patented drugs. It’ll make 2016 a big year for consumers who are in need of such medication.

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  • February 3, 2016 at 2:46 pm

    Can you tell me the estimated annual sales of AcipHex Sprinkle; Epzicon; Kaletra; Norvir; and Ambisome? The precise numbers are not included on your graph and I don’t want to extrapolate and be wrong. Thanks!

    • February 9, 2016 at 1:27 pm

      Hi Sheryl,

      I’m glad we were able to connect offline so we could share the information you were looking for. Please let us know if there is anything you’re still in need of!

  • February 6, 2016 at 9:44 pm
    David Lash

    This is a great graph, but I did not see that it included Cubicin, an antibiotic which may go generic in mid-2016, and is possibly a $1 billion drug, bigger than some of those that you did include. Thank you for your comment.

    • February 9, 2016 at 1:30 pm

      Thanks for pointing this out to us. It’s a few years old, but here’s a great article we found from Bloomberg that really goes into detail on Cubicin and why it may be in a class of it’s own.

  • April 23, 2016 at 3:02 pm

    Hi Jeff –

    Great article. Can you connect with me offline — I have some questions. Thanks!

    Chief Content Director, Pharmaceutical Manufacturing

    • April 26, 2016 at 1:56 pm

      Thanks for the support Karen. I look forward to connecting offline!

  • November 4, 2016 at 11:12 am

    Hi, great infograph!

    Do you have a reference for the 90% siphoning of sales by generics?


  • December 30, 2016 at 11:21 am

    Hi Jeff,

    Any word on whether a 2017 infographic will soon be published? Thanks!

    • December 30, 2016 at 11:24 am

      The story has been written and the research has been compiled. We are just awaiting the completion of the infographic, hopefully in the next week or two. Would you like me to send you a link when it’s officially posted?


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