Details for Patent: 10,689,346

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Which drugs does patent 10,689,346 protect, and when does it expire?

Patent 10,689,346 protects ORLADEYO and is included in two NDAs.

Protection for ORLADEYO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-three patent family members in thirty-three countries.

Summary for Patent: 10,689,346

Title:	Human plasma kallikrein inhibitors
Abstract:	Disclosed are compounds of formula I as described herein, and pharmaceutically acceptable salts thereof. The compounds are inhibitors of plasma kallikrein. Also disclosed are pharmaceutical compositions comprising at least one such compound, and methods involving use of the compounds and compositions in the treatment and prevention of diseases and conditions characterized by unwanted plasma kallikrein activity.
Inventor(s):	Pravin L. Kotian, Yarlagadda S. Babu, Minwan Wu, Venkat R. Chintareddy, V. Satish Kumar, Weihe Zhang
Assignee:	Biocryst Pharmaceuticals Inc
Application Number:	US16/400,798
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,689,346
Patent Claim Types: see list of patent claims	Use;

Drugs Protected by US Patent 10,689,346

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	10,689,346*PED				Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes	10,689,346*PED				Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776-001	Dec 11, 2025		RX	Yes	No	10,689,346*PED				Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776-002	Dec 11, 2025		RX	Yes	No	10,689,346*PED				Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776-003	Dec 11, 2025		RX	Yes	No	10,689,346*PED				Y
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776-004	Dec 11, 2025		RX	Yes	Yes	10,689,346*PED				Y

International Family Members for US Patent 10,689,346

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3113772		301142	Netherlands
European Patent Office	3113772		CA 2021 00040	Denmark
European Patent Office	3113772		PA2021524	Lithuania
European Patent Office	3113772		LUC00233	Luxembourg
European Patent Office	3113772		2021C/544	Belgium
European Patent Office	3113772		122021000062	Germany