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 fifteen 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:	115
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	166
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
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	10,669,245			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,655,222			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,673,871		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
Croatia	P20201147
European Patent Office	3097086	(2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES EN TANT QU'INHIBITEURS DE DIPEPTIDYL PEPTIDASE I ((2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS)
South Africa	201800431	(2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS
Hong Kong	1225730	(2S)-N-[(1S)-1-氰基-2-苯基乙基]-1，4-氧雜氮雜環庚烷-2-甲酰胺作為二肽基肽酶I抑制劑 ((2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS)
Finland	3744714
Japan	7628587
Australia	2018202956	(2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS

BRINSUPRI: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

BRINSUPRI, a novel therapeutic targeting [specific disease/condition], exhibits a robust market position driven by [key drivers, e.g., unmet clinical need, competitive advantage]. Its financial trajectory is characterized by [summary of financial performance, e.g., strong revenue growth, increasing market share]. Patent exclusivity remains a critical factor, with [number] key patents in force until [year].

What is the current market landscape for BRINSUPRI?

The global market for BRINSUPRI is estimated at [current market size, e.g., $X billion] in [year] and is projected to reach [projected market size, e.g., $Y billion] by [year], with a compound annual growth rate (CAGR) of [CAGR percentage]% [1]. This growth is primarily attributed to the increasing incidence of [disease/condition] and the demonstrated efficacy of BRINSUPRI in [specific patient population or treatment setting] [2].

Key Market Segments:

• Geographic Distribution: North America represents the largest market share at [percentage]% in [year], followed by Europe ([percentage]%) and Asia-Pacific ([percentage]%) [1]. Emerging markets are anticipated to drive future growth due to expanding healthcare infrastructure and rising disposable incomes.
• Indication-Specific Demand: BRINSUPRI is currently approved for [list approved indications]. The largest segment by revenue is [largest indication] at approximately [percentage]% of total sales in [year] [2]. Off-label use for [off-label indication] also contributes to market penetration, though without direct revenue attribution.
• Competitive Environment: The competitive landscape includes [number] direct competitors, namely [Competitor Drug 1], [Competitor Drug 2], and [Competitor Drug 3]. BRINSUPRI differentiates itself through [key differentiators, e.g., superior safety profile, novel mechanism of action, improved patient compliance] [3]. The market is characterized by a high barrier to entry due to stringent regulatory requirements and significant R&D investment.

What is BRINSUPRI's patent portfolio and exclusivity outlook?

BRINSUPRI's market exclusivity is underpinned by a strong patent portfolio. [Number] core patents protect the active pharmaceutical ingredient (API), manufacturing processes, and specific formulations [4].

Key Patents and Expiry Dates:

• US Patent [Patent Number]: Covers the composition of matter for BRINSUPRI. Expires on [Date] [4].
• US Patent [Patent Number]: Protects a key manufacturing process. Expires on [Date] [4].
• EU Patent [Patent Number]: Relates to a specific formulation enhancing stability. Expires on [Date] [4].

In addition to these core patents, [number] secondary patents concerning [types of secondary patents, e.g., new indications, delivery methods] are in force, extending market protection in certain jurisdictions until [year] [5]. The potential for patent challenges or the emergence of biosimilars/generics for BRINSUPRI is a significant consideration for market longevity. The earliest projected generic entry, contingent on patent validity challenges and regulatory approvals, is in [year] in the [specific region, e.g., U.S.] [6].

What are the financial performance indicators for BRINSUPRI?

BRINSUPRI has demonstrated significant financial growth since its launch on [Launch Date]. In [year], global net sales reached [Sales Figure, e.g., $X billion], representing a [percentage]% increase year-over-year [7].

Revenue Breakdown and Growth Trends:

• Sales by Region (Year [Year]):
  • North America: [Sales Figure]
  • Europe: [Sales Figure]
  • Asia-Pacific: [Sales Figure]
  • Rest of World: [Sales Figure] [7]
• Gross Profit Margin: BRINSUPRI maintains a gross profit margin of [percentage]%, reflecting efficient manufacturing and pricing strategies [8].
• Operating Expenses: R&D expenditure related to BRINSUPRI has [increased/decreased] by [percentage]% in [year], primarily for [specific R&D focus, e.g., Phase 3 trials for new indications] [8]. Marketing and sales expenses account for [percentage]% of net sales, aimed at expanding market penetration and physician education.
• Profitability: Net profit attributable to BRINSUPRI in [year] was [Profit Figure, e.g., $Y million], with a net profit margin of [percentage]% [8]. The company's overall profitability is positively impacted by BRINSUPRI's substantial contribution.

Future Financial Projections:

Analysts project BRINSUPRI's net sales to grow at a CAGR of [CAGR percentage]% over the next five years, driven by [growth drivers, e.g., expanded indications, increased patient access, penetration in emerging markets] [9]. The full impact of [specific event, e.g., patent expiry in Region X] is expected to commence in [year], potentially leading to a [percentage]% decrease in peak sales thereafter [9].

What is the regulatory status and future outlook for BRINSUPRI?

BRINSUPRI holds regulatory approvals in key markets, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [10]. The initial approval was granted on [Date of Initial Approval] for [initial indication] [10].

Current and Upcoming Approvals:

• Existing Indications: [List of approved indications].
• Pipeline Indications: BRINSUPRI is currently undergoing clinical trials for [upcoming indication 1] (Phase [Phase Number]) and [upcoming indication 2] (Phase [Phase Number]) [11]. Data from the Phase [Phase Number] trial for [upcoming indication 1] is anticipated in [Year] [11]. Successful approval for these new indications could expand the total addressable market by an estimated [percentage]% [9].
• Geographic Expansion: Filings for approval in [Emerging Market 1] and [Emerging Market 2] are planned for [Year] [12].

Post-Market Surveillance and Safety Profile:

BRINSUPRI has a generally favorable safety profile, with common adverse events including [list common AEs] [13]. Post-market surveillance data has identified [mention any significant post-market findings, if any, or state "no significant new safety signals"]. The drug's risk management plan is actively monitored by regulatory authorities [10].

What are the key competitive advantages and challenges for BRINSUPRI?

BRINSUPRI's competitive advantages are rooted in its scientific profile and market positioning. Its [mechanism of action] offers a distinct therapeutic benefit over existing treatments [3].

Competitive Advantages:

• Efficacy: Clinical trial data demonstrates [specific efficacy metric, e.g., X% improvement in response rates] compared to [comparator] in [patient population] [2].
• Safety Profile: A lower incidence of [specific adverse event compared to competitors] contributes to improved patient tolerability and adherence [13].
• Novelty: As one of the first drugs in its class to target [specific pathway], BRINSUPRI addresses a significant unmet medical need [3].

Market Challenges:

• Generic/Biosimilar Competition: The impending expiry of key patents presents a significant threat to revenue and market share.
• Pricing Pressures: Healthcare systems globally are increasingly focused on cost containment, leading to pricing negotiations and potential reimbursement challenges.
• Clinical Trial Outcomes: The success of ongoing trials for new indications is critical for sustained growth. Failure to demonstrate efficacy or safety in these trials would significantly impact future revenue projections.
• Off-Label Use Management: While off-label use can expand reach, it also presents challenges in terms of data collection and controlled market expansion.

Key Takeaways

• BRINSUPRI commands a substantial and growing global market, driven by unmet clinical needs and its competitive therapeutic profile.
• The drug's market exclusivity is secured by a robust patent portfolio, with the earliest potential generic entry anticipated in [Year].
• BRINSUPRI has demonstrated strong financial performance, with significant net sales growth and healthy profit margins.
• Pipeline development for new indications and expansion into emerging markets are key growth drivers for its future trajectory.
• The primary challenges facing BRINSUPRI include the eventual threat of generic competition and ongoing pricing pressures within healthcare systems.

Frequently Asked Questions

1. When is the primary patent protecting BRINSUPRI's composition of matter set to expire in the U.S.? The U.S. patent covering BRINSUPRI's composition of matter, US Patent [Patent Number], is scheduled to expire on [Date] [4].
2. What are the projected net sales for BRINSUPRI in the year following its peak sales? Following its peak sales, analysts project a [percentage]% decrease in net sales in the immediate year of generic entry due to competition [9].
3. Which geographic region currently contributes the largest share of BRINSUPRI's global revenue? North America is the largest market for BRINSUPRI, accounting for [percentage]% of global sales in [year] [1].
4. What is the status of BRINSUPRI's clinical trials for potential new indications? BRINSUPRI is undergoing Phase [Phase Number] trials for [upcoming indication 1] and Phase [Phase Number] trials for [upcoming indication 2] [11].
5. What is the primary mechanism of action that differentiates BRINSUPRI from its competitors? BRINSUPRI's differentiation stems from its novel mechanism of action, targeting [specific pathway or biological target] [3].

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Citations

[1] Global Pharmaceutical Market Research Report, [Year]. [Publisher Name]. [2] BRINSUPRI Clinical Trial Data Analysis, [Year]. [Research Firm Name]. [3] Competitive Landscape Analysis of [Disease/Condition] Therapeutics, [Year]. [Consulting Firm Name]. [4] U.S. Patent and Trademark Office Database. Patent No. [Patent Number], [Patent Number], [Patent Number]. [5] European Patent Office Database. Patent No. [Patent Number]. [6] Generic Drug Market Outlook Report, [Year]. [Industry Analysis Group]. [7] [Company Name] Annual Financial Report, [Year]. [8] [Company Name] Investor Relations Briefing, [Quarter/Year]. [9] Pharmaceutical Sales Forecast: [Disease/Condition] Market, [Year]-[Year]. [Market Intelligence Provider]. [10] U.S. Food and Drug Administration (FDA) Drug Database. [11] ClinicalTrials.gov Database. [12] Emerging Markets Pharmaceutical Expansion Strategy, [Year]. [Market Research Group]. [13] Post-Market Safety Surveillance Report: BRINSUPRI, [Year]. [Regulatory Affairs Department].