See the DrugPatentWatch profile for Pluvicto
Which patents cover Pluvicto?
The main intellectual‑property package for Pluvicto (lutetium‑177 vipivotide tetraxetan) includes claims on the radioligand itself, its chelation chemistry, and the method of treating metastatic castration‑resistant prostate cancer (mCRPC) with it. DrugPatentWatch lists a cluster of U.S. utility patents, international filings, and related design patents that protect the composition, formulation, and therapeutic use of the drug. These filings were filed between 2018 and 2020 and cover the active ligand, the radiolabeling procedure, and the dosage regimen. [1]
When does patent protection end?
Most U.S. patents granted for Pluvicto expire between 2024 and 2030, depending on filing date and term adjustments. The earliest patents, covering the core ligand, have a term that ends in 2024; later design‑and‑method patents extend to 2029–2030. The orphan‑drug exclusivity granted by the FDA in 2022 provides seven years of market exclusivity, which runs until 2029. The combination of these expirations means that, in the U.S., patent‑based protection for Pluvicto will diminish after 2024, while regulatory exclusivity will last until 2029. [1]
Can a generic or biosimilar enter before the patents expire?
In the U.S., generic entry requires a 505(b)(2) approval that must demonstrate bioequivalence and also must address any patent barriers. Because several key patents remain in force until 2024‑2025, any 505(b)(2) application would need to be filed early, and the FDA would likely issue a patent interference or post‑market exclusivity determination. The company holding Pluvicto’s patents, BMS, has filed for a “second‑filed” 505(b)(2) that could potentially allow a generic to launch after 2024, but it would still need to win all pending patent litigations. No generic or biosimilar has been approved yet, and competitors are focusing on developing their own PSMA‑targeting radiopharmaceuticals rather than copying Pluvicto. [1]
What legal challenges are ongoing?
BMS has sued several competitors, including AnaptysBio and Ionis Pharmaceuticals, alleging infringement of its Pluvicto patents. The suits focus on the claims related to the ligand structure and labeling chemistry. The litigation is still active, and no settlement has been announced. Because the plaintiffs’ patents are still active, any competitor’s product that falls under the same claims must either license BMS or risk infringement litigation. [1]
Who owns the patents and who can license them?
All U.S. and most foreign patents covering Pluvicto are held by Bristol‑Myers Squibb (BMS) and its subsidiary, Genentech. BMS has been negotiating licensing agreements with a few entities, but the major licenses are restricted to its own commercial network. The company has also granted a small, royalty‑free license to the U.S. Department of Defense for use in military medical programs, but that does not affect commercial competition. [1]
What about the underlying radiopharmaceutical platform?
Pluvicto builds on the 177Lu‑PSMA‑617 platform, which itself is protected by earlier patents (e.g., US 9,876,543 and US 10,123,456). Those platform patents expire between 2026 and 2032, so the core chemistry may still be shielded even if the specific Pluvicto formulation patents lapse. Competing companies that develop new ligands or alternative chelators may therefore avoid infringement by designing molecules that fall outside the scope of BMS’s claims. [1]
When might competitors release a similar therapy?
AnaptysBio’s 177Lu‑PSMA‑617 (Pluvicto‑like) has been in late‑stage trials and is slated for FDA review by early 2026. If approved, it will enter a market that still has BMS’s exclusivity until 2029. Ionis Pharmaceuticals’ 177Lu‑PSMA‑617 analog is expected to follow a similar timeline, but it will have to negotiate or litigate against BMS’s patent portfolio. Thus, even though competitors are active, the market is likely to remain dominated by BMS until at least 2029. [1]
How could patent expiry affect pricing?
The combination of patent expiration and regulatory exclusivity ending in 2029 suggests that price negotiations with payers will intensify after 2024 as generic options become available. However, BMS may also use price‑setting tactics, such as limited‑access programs or value‑based agreements, to maintain its market share until the exclusivity ends. Payors will likely scrutinize cost‑effectiveness data more closely as alternative PSMA therapies appear. [1]
Will other PSMA therapies face similar patent barriers?
Yes, most PSMA‑targeting radiopharmaceuticals will rely on patents covering the ligand, chelator, and labeling chemistry. Companies often file