Lanthanum loss of exclusivity?

When did lanthanum carbonate lose its exclusivity?
Lanthanum carbonate (brand name Epsyl) was first approved by the FDA in 2008. Five‑year exclusivity for a new drug application expired in 2014, and the first generic version—lanthanum carbonate 500 mg tablets—was approved that same year, marking the drug’s loss of market exclusivity [1].

Which patents kept the drug exclusive longer?
Eli Lilly retained several key patents: a composition patent (U.S. Pat. No. 5,943,213, expired 2009) and a use patent (U.S. Pat. No. 6,064,236, expired 2014). A separate formulation patent extended protection until 2016, allowing the brand to maintain a monopoly beyond the statutory exclusivity window [2].

Who entered the market after exclusivity ended?
Teva Pharmaceuticals was the first to launch a generic in 2014. Other manufacturers—such as Sandoz, Mylan, and Sun Pharma—followed in 2015 and 2016, offering 500 mg tablets at prices well below the brand cost [3][4].

How has the price changed?
At launch, Epsyl cost roughly $1,600–$2,000 per month for a typical dialysis patient. Generic tablets began at about $1.10–$1.50 each in 2014, translating to a 90 % price drop for monthly supplies [5]. The brand’s price has since fluctuated but remains higher than generics.

What does this mean for dialysis patients?
Generic availability has expanded treatment options and reduced out‑of‑pocket expenses. However, some clinicians note concerns about bioequivalence in patients with severe hyperphosphatemia, so prescribers often monitor phosphate levels after switching [6].

Is the brand drug still on the market?
Yes. Eli Lilly continues to market Epsyl, citing patented excipient formulations that offer faster gastric clearance. The brand remains popular in regions where insurance plans favor brand-name drugs