End of an era in antibiotic blockbusters as FDA approves Levaquin generics
This article was originally published in Scrip
The US Food and Drug Administration has approved the first generic versions of Johnson & Johnson’s blockbuster antibacterial drug Levaquin (levofloxacin). Twelve companies, including generic heavyweights Mylan and Teva Pharmaceutical Industries, had applied to market generic versions of the drug in the lucrative US market.
The US Food and Drug Administration (FDA) has granted marketing approval to twelve companies for generic versions of Johnson & Johnson’s “blockbuster” antibacterial drug Levaquin (levofloxacin). The drug yielded sales of $1.3bn in the US in 2010, and is being targeted by some of the world’s largest generics manufacturers, including Mylan, Teva, and Dr. Reddy’s. The FDA decision covers both tablet and injectable solution forms of the drug. Levofloxacin, which is marketed in Japan by Daiichi Sankyo as Cravit and in Europe by Sanofi as Tavanic, is currently the biggest-selling antibacterial drug by some distance.
Levofloxacin is a broad-spectrum fluoroquinolone drug which has activity against a broad range of Gram-positive and Gram-negative bacteria. The popularity of the drug stems from its broad range of approved indications, including very strong coverage of respiratory and genitourinary infections, its availability in an oral formulation (affording use in the community setting), strong brand power, and the sales and marketing power of its marketing companies. Levaquin is just one of J&J’s portfolio of “blockbuster” drugs facing patent expiry and the threat of generic erosion over the next five years is threatening the company’s prospects for growth. J&J is also disproportionately exposed to the US market, in which levels of generic erosion are highest.
Levofloxacin represents one of the last remaining “blockbuster” antibacterial brands. The community sector, in particular, has become increasingly saturated with cheap generic products which have caused steep declines in the sales of previous antibacterial blockbusters, including Pfizer’s Zithromax (azithromycin), Abbott’s Klacid/Clarith/Naxy (clarithromycin), and Bayer’s Cipro/Ciproxin/Ciproxan (ciprofloxacin). This has been the keen driver in the shrinkage and increasing fragmentation of the antibacterials market over the last 5 years, with levels of generic erosion in the lucrative US market being as high as 80-90%. Consequently, the launch of new hospital brands targeting infections caused by methicillin-resistant Staphylococcus aureus (MRSA) remains the principal source of revenue growth in the sector.
Datamonitor believes that, despite the projected loss of a significant proportion of sales, Levaquin will continue to represent a valuable source of revenue for J&J, led by the strong reputation of the brand and physician familiarity with the drug. Despite the threat of generic products, the scale of Levaquin, Cravit, and Tavanic sales will mean that branded levofloxacin will maintain its position as the leading branded antibacterial product in the seven major markets over the next decade, even after the launch of generic competitors in the US, albeit by a narrow margin. While Levaquin sales will no doubt suffer in light of competition from generic products, this drop will be offset by much smaller sales declines in Japan and the five major EU markets, for which levels of generic erosion are much less pronounced. Datamonitor currently forecasts collective sales of Levaquin, Cravit, and Tavanic to decline to $530m in the seven major markets in 2019.