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See the DrugPatentWatch profile for Erleada
Short answer: The primary patents that protect Erleada® (apalutamide) in the United States are set to expire in 2028–2029. Johnson & Johnson does not own the Erleada patents – they are held by Pfizer (and its subsidiaries). Johnson & Johnson has no direct patent rights on Erleada itself, although it might hold or be negotiating licensing agreements for generic or biosimilar versions once those patents expire.
The above list is not exhaustive—there are a handful of secondary patents (e.g., on specific dosing schedules, combination therapies, and analytical methods) that also expire in 2029 or later. The “first‑to‑file” and “first‑to‑use” dates for the U.S. patents are what determine the actual commercial exclusivity period.
Generic or biosimilar interest: Once Pfizer’s core patents lapse, other companies—including Johnson & Johnson (J&J)—could potentially enter the market with a generic version of apalutamide. J&J has a long history of developing generics through its “J&J Pharma” and “Bristol‑Myers Squibb” (via a joint venture) units, so it is common to hear about J&J in discussions of the Erleada pipeline.
Licensing and collaborations: In the U.S., Pfizer has licensed some of its apalutamide patents to other firms for specific uses (e.g., combination therapy with a J&J‑developed androgen‑deprivation agent). These arrangements are licensing agreements, not ownership of the patents themselves.
Potential future patents: J&J might file patents on new formulations (e.g., extended‑release tablets) or delivery devices that use apalutamide after the primary patents expire. Those would be J&J’s own patents, not the original Pfizer patents.
Current exclusivity: Because the patents are still active, Pfizer remains the sole FDA‑approved manufacturer of Erleada. Any use of the drug must come from Pfizer (or its authorized distributors).
Cost & insurance: The drug remains expensive (~$4–5 k/month for a 30‑day supply). Insurance coverage is typically limited to approved indications (non‑metastatic castration‑resistant prostate cancer).
Generic availability: Expect a generic version of apalutamide in the U.S. after 2028–2029 (assuming no extension or secondary patent challenges). Generic pricing could cut the cost by 70–80 %, but it will still need to be covered by insurers, and patients may face a short “exclusivity” period for the generic.
Clinical trials: J&J is not currently sponsoring clinical trials for apalutamide. However, they might be interested in future studies that combine apalutamide with their own agents (e.g., J&J’s androgen‑receptor modulators) once the exclusivity period ends.
If you’re a prescriber or a patient looking for cost‑effective options, keep an eye on FDA approvals of generic apalutamide after the 2028–2029 window. The exact launch date will depend on the FDA’s review of the generic application, but most generics hit the market a few months after the patent expiry.
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