Last Updated: August 6, 2026

Details for Patent: 12,611,397

Name: Drug Patent Intelligence for US Patent 12611397
Creator: DrugPatentWatch
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Which drugs does patent 12,611,397 protect, and when does it expire?

Patent 12,611,397 protects NUBEQA and is included in one NDA.

This patent has thirteen patent family members in eight countries.

Summary for Patent: 12,611,397

Title:	Pharmaceutical composition of darolutamide
Abstract:	The present invention relates to a pharmaceutical composition for oral administration, particularly in the form of a tablet, comprising darolutamide or a pharmaceutically acceptable salt thereof as an active ingredient. Darolutamide is a potent androgen receptor (AR) modulator useful in the treatment of cancer, particularly AR dependent cancer such as prostate cancer, and other diseases where AR antagonism is desired.
Inventor(s):	Susanna ILMONEN, Juha LINTUNEN, Petteri LYYTINEN, Marko Saalasti
Assignee:	Orion Oyj
Application Number:	US19/182,859
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Device; Dosage form;

Drugs Protected by US Patent 12,611,397

Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	12,611,397	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

International Family Members for US Patent 12,611,397

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020300043	⤷ Start Trial
Australia	2025202455	⤷ Start Trial
Canada	3145459	⤷ Start Trial
China	114144168	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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