BRINSUPRI Drug Patent Profile

Which patents cover Brinsupri, and when can generic versions of Brinsupri launch?

Brinsupri is a drug marketed by Insmed Inc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and eighteen patent family members in thirty-nine countries.

The generic ingredient in BRINSUPRI is brensocatib. One supplier is listed for this compound. Additional details are available on the brensocatib profile page.

DrugPatentWatch^® Generic Entry Outlook for Brinsupri

Brinsupri will be eligible for patent challenges on August 12, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 21, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BRINSUPRI

International Patents:	118
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	173
What excipients (inactive ingredients) are in BRINSUPRI?	BRINSUPRI excipients list
DailyMed Link:	BRINSUPRI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BRINSUPRI

Constraining patent/regulatory exclusivity:

12,059,424

NDA:

217673

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for BRINSUPRI

BRINSUPRI is protected by fourteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 12,059,424.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	9,522,894			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	12,059,424		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	12,054,465			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	11,773,069		Y

International Patents for BRINSUPRI

When does loss-of-exclusivity occur for BRINSUPRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Moldova, Republic of

Morocco

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BRINSUPRI around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	099177
Australia	2015208932
Australia	2017200338
Australia	2018202956

Supplementary Protection Certificates for BRINSUPRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3097086	CA 2026 00019	Denmark		PRODUCT NAME: BRENSOCATIB OG SALTE HERAF, HYDRATER, ELLER HYDRATER AF SALTENE, HERUNDER BRENSOCATIB MONOHYDRAT; REG. NO/DATE: EU/1/25/1995 20251119
3097086	C20265009	Finland
3097086	LUC50047	Luxembourg		PRODUCT NAME: BRENSOCATIB OU SES SELS, SES HYDRATES OU LES HYDRATES DE SES SELS, Y COMPRIS LE BRENSOCATIB MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/25/1995/001 20251119
3097086	301376	Netherlands		PRODUCT NAME: BRENSOCATIB OR ITS SALTS,HYDRATES, OR HYDRATES OF THE SALTS, INCLUDING BRENSOCATIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/25/1995/001 20251119