The patent cliff is coming up fast. While some companies won't feel the heat for a few more years -- Pfizer's
Year-over-year comparisons in 2009 won't be pleasant for GlaxoSmithKline
Fortunately, Glaxo is a big company. With more than $41 billion in revenue over the last 12 months, it can afford to lose a few blockbusters without seeing overall revenue drop too much. But then again, as the saying goes, a billion here, a billion there, and pretty soon you're talking real money.
Guilt by association
Boehringer Ingelheim's BPH treatment, Flomax, and UCB's epilepsy drug, Keppra, will both face generic competition next year. Most U.S.-based Fools won't be invested in either company -- neither company's shares are available on the major U.S. exchanges -- but that doesn't mean you should ignore them.
You see, it's quite common for competing drugs to take a hit when one drug goes generic. Doctors tend to favor the generic version when starting new patients with a treatment, and they may even switch patients from a branded drug not facing direct generic competition to the generic form of a competing drug. For instance, Pfizer saw U.S. sales of Lipitor decline when Merck's
Getting back to Flomax and Keppra, and what that might mean for you, sales of both Sanofi-Aventis'
Patents versus exclusivity
While some authors -- guilty as charged -- use the terms interchangeably, these two words really don't have the same meaning. The exclusivity period for selling a drug without generic competition can actually be shorter or longer than the patents.
Generic competition can come before patents expire, when drugmakers settle lawsuits with generic drugmakers to avoid the potential of losing patent-infringement court cases. The drugmakers allow the generic-drug company to launch before the patent runs out, and if they've got the upper hand in negotiations, they'll often take a cut of the generic sales in royalties. As an example, Teva Pharmaceuticals
On the flip side, drugmakers can also extend the exclusivity period by doing research on the drug's use in children. For spending the money, the FDA gives the company a six-month extension before it'll approve generic equivalents. For instance, Johnson & Johnson's
You should care, too
Even if you're not invested in any of the companies about to receive generic competition, the events could affect you, too -- in a good way. If you're taking any of the above drugs, consult your physician about switching to the generic version. If you're on insurance, you'll probably see a drop in the copayment, and if you're winging it without health insurance, or in the Medicare donut, you'll likely see your costs drop substantially.
Authors have been warning about the patent cliff for years, but it's up to investors to get the scoop on when individual drugs face the end of their exclusivity. Do your own homework and try to estimate the revenue of the company after the loss of exclusivity. Some companies, like Pfizer, are looking pretty good, despite their impending loss of revenue.