Pharsight

1. List of Brukinsa drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9447106	BEIGENE	Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators	Apr, 2034 (11 years from now)
US10570139	BEIGENE	Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators	Apr, 2034 (11 years from now)
US11142528	BEIGENE	Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators	Apr, 2034 (11 years from now)
US10927117	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (14 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11591340	BEIGENE	NA	Aug, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 14, 2024
Orphan Drug Exclusivity (ODE)	Sep 14, 2028
New Indication (I)	Sep 14, 2024

NCE-1 date: 2023-11-15

Market Authorisation Date: 14 November, 2019

Treatment: For the treatment of patients with waldenstrom's macroglobulinemia; Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy; Treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll); Treatment of adult patients with chronic lymphocytic leukemia; Relapsed or refractory marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based regimen; Treatment of adult patients with small lymphocytic lymphoma

Dosage: CAPSULE;ORAL