Details for Patent: 11,168,058

Which drugs does patent 11,168,058 protect, and when does it expire?

Patent 11,168,058 protects NUBEQA and is included in one NDA.

This patent has thirty-four patent family members in twenty-three countries.

Summary for Patent: 11,168,058

Title:	Manufacture of a crystalline pharmaceutical product
Abstract:	The present disclosure relates to crystalline particles of N—((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide (I) having specific surface area (SSA) in the range from about 8 to about 16 m2/g, preferably from about 10 to about 15 m2/g, and to the method for the preparation of such particles. Compound (I) is a potent androgen receptor (AR) modulator which is useful as a medicament for example in the treatment of prostate cancer.
Inventor(s):	Merja Reunanen, Anna STAFFANS
Assignee:	Orion Oyj
Application Number:	US16/491,642
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,168,058
Patent Claim Types: see list of patent claims	Process; Dosage form;

Drugs Protected by US Patent 11,168,058

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	11,168,058		Y	Y

Foreign Priority and PCT Information for Patent: 11,168,058

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Finland	20175202	Mar 7, 2017

PCT Information
PCT Filed	February 27, 2018	PCT Application Number:	PCT/FI2018/050143
PCT Publication Date:	September 13, 2018	PCT Publication Number:	WO2018/162793

International Family Members for US Patent 11,168,058

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018229817
Brazil	112019018458
Canada	3055019
Canada	3292509
Chile	2019002540