Last Updated: November 8, 2026

Details for Patent: 12,545,646

Name: Drug Patent Intelligence for US Patent 12545646
Creator: DrugPatentWatch
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Which drugs does patent 12,545,646 protect, and when does it expire?

Patent 12,545,646 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 twenty-four patent family members in twenty-one countries.

Summary for Patent: 12,545,646

Title:	Crystalline salts of a plasma kallikrein inhibitor
Abstract:	Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention.
Inventor(s):	Yahya El-Kattan, Yarlagadda S. Babu
Assignee:	Biocryst Pharmaceuticals Inc
Application Number:	US19/312,755
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Drugs Protected by US Patent 12,545,646

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
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y		⤷ Start Trial
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776-001	Dec 11, 2025		RX	Yes	No	⤷ Start Trial	⤷ 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 12,545,646

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	116951	⤷ Start Trial
Australia	2019374115	⤷ Start Trial
Brazil	112021008249	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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