Top 10 Drug Patent Losses of 2014


In a way, the coming year isn’t a big one for patent expirations. The total amount of sales jeopardized by patent expirations is $34 billion. That’s more than the $28 billion this year, but far less than the $55 billion that hit in 2012. As for 2015? Forget about it. That year, products worth $66 billion will lose IP protection.

Plus, the drugs facing new competition won’t all take a big hit in 2014. In fact, EvaluatePharma figures that the products newly open to generic competition will only lose $13 billion off their previous totals.

But if you’re one of the companies looking at sudden exposure to would-be copycats, 2014 might be a very big year indeed. Consider Teva Pharmaceutical Industries ($TEVA), best known for its generic drugs. Its top seller is actually a branded medication: Copaxone, a blockbuster multiple sclerosis treatment. Teva has been scrambling to develop a longer-acting follow-up to Copaxone, hoping to woo patients to the new product before the old one loses exclusivity. A U.S. appeals court cut that timeframe short earlier this year, when it invalidated a key patent. Now, Copaxone looks to lose exclusivity in May 2014, rather than November 2015 as previously expected. That’s almost $3 billion in sales in the U.S. at risk.

And then there’s AstraZeneca ($AZN), which faces generic rivals for its famous “purple pill”: Nexium. The acid-reflux treatment goes off patent in May 2014. Of the drug’s $3.994 billion in global sales for 2012, almost $2.3 billion came from the U.S. Naturally, AstraZeneca has been dreading that day for years. In fact, the company has been making one deal after another, aiming to build up a strong enough pipeline to counter the Nexium losses with new sales. The company also loses another patent on Symbicort next year–a method-of-use patent–but the drugs included in the combination inhaler have both already lost exclusivity. So, the inhaled asthma and COPD treatment won’t be quickly copied.

In fact, several companies have more than one drug facing patent loss in 2014. Novartis ($NVS) loses exclusivity on Sandostatin LAR and Exforge, both in the top 10. Then there’s Allergan ($AGN), with Restasis and Lumigan, which didn’t make the top 10. A key patent on Lumigan expires in August, though the company is defending another that doesn’t run out ’til 2027. Finally, there’s Warner Chilcott ($WCRX), which has a trifecta, even if it’s not obvious from the list below. The company’s bone drug Actonel, colitis treatment Asacol HD and contraceptive Loestrin 24 Fe all lose exclusivity next year. Warner has already stopped selling the latter, however, aiming to convert patients to a newer version, and it’s steering Asacol patients toward its newer drug Delzicol.

We ranked these drugs by global sales in 2012; neither Boehringer Ingelheim, a private company, nor Allergan breaks out U.S. sales of its product listed below. We’ve included U.S. numbers for the rest. Sales figures are from the company’s earnings announcements and Securities and Exchange Commission filings. For companies reporting in foreign currencies–Boehringer and Sanofi ($SNY)–we converted sales figures according to the exchange rate on the last day of the relevant period. Any questions or comments? Let us know directly, or start a discussion with FiercePharma’s LinkedIn group. — Tracy Staton (email | Twitter)

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