Process for Preparation of Apalutamide, Synthon B.V., Apr 21
Summary
The USPTO granted patent US12606539B2 to Synthon B.V. (a Dutch biopharmaceutical company) for a process to synthesize Apalutamide, along with its solid forms, salts, and solvates, and intermediates used therein. The patent application (18043777) was filed September 3, 2021, and carries 14 claims under CPC classifications C07D 401/04 and C07C 229/48. This grant gives Synthon B.V. exclusionary rights over this synthetic route for the prostate cancer drug.
What changed
The USPTO granted patent US12606539B2 to Synthon B.V. on April 21, 2026, covering a process for preparing Apalutamide (compound 1), its salts and solvates, and solid forms thereof, as well as solid forms of intermediates used in the preparation process. The patent application was filed September 3, 2021 (Application No. 18043777) and contains 14 claims classified under C07D 401/04 and C07C 229/48.\n\nPharmaceutical companies engaged in API or intermediate manufacturing should review freedom-to-operate positions in light of this newly granted patent. Patent holders and licensees may need to assess whether this process patent creates any overlap with or obstacle to existing IP strategies or licensing arrangements.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Process for preparation of apalutamide
Grant US12606539B2 Kind: B2 Apr 21, 2026
Assignee
Synthon B.V.
Inventors
Ondrej Hylse, David Chalupa, Bohumil Dymacek, Marian Buchlovic
Abstract
The presented invention relates to a process for preparation of Apalutamide, compound (1) or a salt or a solvate thereof: The presented invention further relates to solid forms of Apalutamide, solvates of Apalutamide and to processes for preparation thereof. The presented invention also relates to solid forms of intermediates used in the process for preparing Compound (1).
CPC Classifications
C07D 401/04 C07C 229/48
Filing Date
2021-09-03
Application No.
18043777
Claims
14
Mentioned entities
Parties
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