AMGN · 10-Q · 2026Q2 · Full report
Regulatory Risk
AMGEN INC · 2026-08-05 · Importance 37 · Surprise 42 · In source text
The OECD issued administrative guidance on January 5, 2026, that, when fully enacted, would exempt U.S. companies from extraterritorial minimum taxes effective January 1, 2026. The United Kingdom, EU member countries and Singapore have enacted global minimum tax rules, with Singapore’s rules applying from 2025 irrespective of Amgen’s incentive grant. The United States enacted OB3 on July 4, 2025, including modifications to the international tax framework and foreign-earnings tax rates, with most provisions effective January 1, 2026. Amgen continues to monitor the potential effect of these measures on its 2026 tax rate.
Key facts
- A claim construction hearing in Amgen Inc. et al. v. Amneal Pharmaceuticals, Dr. Reddy’s, Alkem et al. will be scheduled after October 21, 2027 and the joint pretrial order is due August 28, 2028. source
- On May 4, 2026, Hetero agreed that the asserted claims of U.S. Patent No. 7,737,112 are valid and enforceable and that its ANDA filing infringed, and the District of Delaware entered an order enjoining Hetero from infringing the asserted claims until expiration or delisting of the '112 Patent. source
- Our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe. source
- Other operating expenses for the three and six months ended June 30, 2026, included litigation expenses and settlements, respectively. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| liability | negative | contingent | — | A claim construction hearing in Amgen Inc. et al. v. Amneal Pharmaceuticals, Dr. Reddy’s, Alkem et al. will be scheduled after October 21,… |
| revenue | positive | realized | — | On May 4, 2026, Hetero agreed that the asserted claims of U.S. Patent No. 7,737,112 are valid and enforceable and that its ANDA filing… |