U.S. Drug Sales and a Patent Cliff


Pills 3 By e-MagineArt.comDrugs.com, a leading online drug resource, just released second quarter 2012 U.S. prescription sales data for the top 100 drugs.

Proton-pump inhibitors, antipsychotics, asthma therapeutics and statins remain the top-selling categories. Plavix and Seroquel dipped in the second quarter due to loss of patent protection. Other top brands such as Singulair, Actos and Diovan are also due to be affected by year’s end.

  1. Nexium — $1,380,413,000
  2. Abilify — $1,379,149,000
  3. Singulair — $1,287,806,000
  4. Advair Diskus — $1,124,985,000
  5. Crestor — $1,124,702,000
  6. Cymbalta — $1,057,821,000
  7. Humira — $1,015,639,000
  8. Enbrel — $948,119,000
  9. Plavix — $934,731,000
  10. Remicade — $933,255,000

Of particular note, Merck’s top-selling asthma and allergy brand Singulair finished the quarter strong, but competition is on the horizon with the first generic versions of Singulair (montelukast) approved by the FDA in early August.

The big loser in Q2 was AstraZeneca’s Seroquel, which dropped 95 places to #100 on the list of the top 100, coming in at $159,858,000 in sales for the quarter.  Seroquel dipped over $1 billion in sales due to loss of patent protection.

“Medicines appearing at the top of the sales data for the second quarter show a strong brand presence, reinforcing the impact of research and development across multiple disease states,” said Philip Thornton, CEO of Drugs.com. “However, as many top brands face patent expiration over the next few years, a reduction in sales of affected medicines will be inevitable – with each expiration contributing to the phenomenon colloquially referred to as the ‘patent cliff.'”

What is a patent cliff?  Investopedia.com defines it as follows:

A colloquialism to denote the potential sharp decline in revenues upon patent expiry of one or more leading products of a firm. A patent cliff is when a firm’s revenues could “fall off a cliff” when one or more established products go off-patent, since these products can be replicated and sold at much cheaper prices by competitors. While it is applicable to any industry, in recent years the term “patent cliff” has come to be associated almost exclusively with the pharmaceutical industry.

The realities presented by a patent cliff often drive giant pharmaceutical companies to acquire smaller pharmaceutical companies and research and development companies to help stack their own pipeline with potential blockbuster drugs to address the enormous drop in revenues that is the hallmark of a patent cliff.

Ideally (or in theory), a pharmaceutical company will not experience patent cliffs because by the time one blockbuster is losing patent protection another blockbuster is ready to take its place.  This ideal situation, however, is not reality.  The development to commercialization cycle can take many twists and turns through the FDA approval process.  Pharmaceutical research and development is anything but predictable.  This is one of the reasons why pharmaceutical companies need to make as much as possible when they do stumble onto a blockbuster drug.  Blockbuster drugs are few and far between and then cannot be pulled out of a hat at a moment’s notice.  That should be self-evident given there are hopes that virtually any drug could become a blockbuster at the early stages of development.

While Seroquel has lost patent protection, the extended release formulation of — Seroquel XR — remains patent protected until 2017.  Seroquel XR was #55 on the top 100 list coming in at $268,017,000 during Q2 2012.

Written by Gene Quinn of IPWatchdog.com


One Response to “U.S. Drug Sales and a Patent Cliff”

  1. Jan says:

    Thanks for the drugs.com mention :)

    BTW, the link in your article to the top 100 drugs is not working, here’s the correct url for it: http://www.drugs.com/stats/top100/sales

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