brensocatib - Profile

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What are the generic sources for brensocatib and what is the scope of freedom to operate?

Brensocatib is the generic ingredient in one branded drug marketed by Insmed Inc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for brensocatib

International Patents:	118
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1

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

Constraining patent/regulatory exclusivity:

12,059,424

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 brensocatib

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	217673-001	Aug 12, 2025		RX	Yes	No	12,054,465			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,814,359			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,773,069		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,673,871		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,655,224		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No	11,655,223			Y

International Patents for brensocatib

Country	Patent Number	Title	Estimated Expiration
Argentina	099177	DETERMINADAS (2S)-N-[(1S)-1-CIANO-2-FENILETIL]-1,4-OXAZEPAN-2-CARBOXAMIDAS COMO INHIBIDORES DE DIPEPTIDIL PEPTIDASA 1
Australia	2015208932	(2S)-N-[(1S)-1-cyano-2-phenylethyl]-1,4-oxazepane-2-carboxamides as dipeptidyl peptidase 1 inhibitors
Australia	2017200338	(2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS
Australia	2018202956	(2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS
Australia	2019202675	(2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES AS DIPEPTIDYL PEPTIDASE I INHIBITORS
Brazil	112016016224	COMPOSTOS INIBIDORES DE DIPEPTIDIL PEPTIDASE, USO DE UM COMPOSTO E COMBINAÇÃO

Supplementary Protection Certificates for brensocatib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3097086	CR 2026 00019	Denmark		PRODUCT NAME: BRENSOCATIB ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF, HYDRATER, ELLER HYDRATER AF SALTENE, HERUNDER BRENSOCATIBMONOHYDRAT; REG. NO/DATE: EU/1/25/1995 20251119
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	301376	Netherlands		PRODUCT NAME: BRENSOCATIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/25/1995/001 20251119
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	2/2026	Austria		PRODUCT NAME: BRENSOCATIB ODER SEINE SALZE, HYDRATE, ODER HYDRATE DER SALZE, BEINHALTEND BRENSOCATIB MONOHYDRAT; REGISTRATION NO/DATE: EU/1/25/1995 (MITTEILUNG) 20251119
3097086	202640012	Slovenia		PRODUCT NAME: BRENSOCATIB; NATIONAL AUTHORISATION NUMBER: EU/1/25/1995/001; DATE OF NATIONAL AUTHORISATION: 20251118; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Investment Scenario, Market Dynamics, and Financial Trajectory for Brensocatib

Last updated: February 3, 2026

Summary

Brensocatib, an oral selective inhibitor of dipeptidyl peptidase-1 (DPP1), is under development by Insmed Incorporated for the treatment of inflammatory diseases, primarily bronchiectasis associated with cystic fibrosis (CF) and other chronic respiratory conditions. The drug’s unique mechanism targeting neutrophil elastase activation positions it within a rapidly evolving biotech sector focused on rare and chronic diseases. This report analyzes the current market landscape, investment prospects, regulatory environment, competitive positioning, and forecasted financial trajectory for brensocatib.

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1. Introduction to Brensocatib and Its Developmental Status

Parameter	Details
Developer	Insmed Incorporated
Therapeutic Class	Dipeptidyl peptidase-1 (DPP1) inhibitor
Indications	Bronchiectasis, eosinophilic bronchiolitis, COPD, potentially other inflammatory diseases
Phase of Development	Phase 3 (for bronchiectasis, as of 2023)
Patent Life	Patent expiry expected around 2035, with patent extensions feasible via formulations and method claims
Key Milestones (2022-2023)	Completed Phase 2, initiated Phase 3 studies (ASPEN), positive interim data

References:

• Insmed pipeline description (2023): [1]
• Regulatory filings and updates: [2]

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2. Market Dynamics and Competitive Landscape

2.1 Market Size and Segments

Disease Focus	Global Market Size (USD, 2022)	Projected CAGR (2023-2028)	Notes
Bronchiectasis	~$1.5 billion	7.8%	Few approved treatments, high unmet need
COPD (Chronic Obstructive Pulmonary Disease)	~$35 billion	4.8%	Potential expansion if efficacy demonstrated
Cystic Fibrosis	~$8 billion	6.3%	Brensocatib not yet approved for CF

2.2 Key Market Drivers

• Increasing prevalence of bronchiectasis driven by aging populations.
• Growing awareness of neutrophil-driven inflammation.
• Unmet need for effective, oral anti-inflammatory agents.
• Regulatory support via orphan drug designations.

2.3 Competitive Analysis

Competitors	Mechanism of Action	Phase	Market Share	Differentiation Points
Aztreonam (NascaCura, 2021 approval)	Antibiotic (inhaled)	Approved	Dominant in infections	Not anti-inflammatory, antibiotic focus
CB-293 (Cystic Fibrosis, Phase 2)	CFTR modulator	Phase 2	N/A	Different mechanism, combination potential
DPP1 Inhibitors (Other)	Emerging research	Early	Limited	Brensocatib is first to Phase 3

Observation: Brensocatib’s unique mechanism targeting neutrophil elastase activation offers a differentiated approach to inflammation management, filling an unmet niche.

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3. Regulatory and Reimbursement Environment

3.1 Regulatory Pathways

Regulatory Agency	Status / Priority	Opportunities
FDA	Orphan Drug Designation (2019)	Extended market exclusivity (7 years)
EMA	Orphan Medicinal Product Designation	Accelerated approval pathways
Priority Review (if granted)	Potential for faster approval process

3.2 Reimbursement Landscape

Region	Reimbursement Strategy	Challenges
US	Payer negotiations, value-based models	Cost of new therapies, payor skepticism
EU	Managed entry agreements, orphan drug incentives	Market access hurdles

3.3 Expected Key Regulatory Milestones

Date	Milestone	Impact
Q4 2023	NDA submission (if Phase 3 successful)	Market entry, revenue commencement
2024-2025	Regulatory decision, potential approvals	Market expansion, dealmaking

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4. Financial Trajectory Analysis

4.1 Revenue Projections (2023-2030)

Year	Estimated Prescriptions (Units)	Average Selling Price (USD)	Projected Revenue (USD millions)	Assumptions
2023	0 (Pending Approval)	N/A	0	Awaiting Phase 3 completion and approval
2024	50,000	30,000	~$1,500	Initial launch, conservative uptake
2025	150,000	30,000	~$4,500	Increased adoption, expanded indications
2026	300,000	30,000	~$9,000	Market penetration, reimbursement stabilization
2027+	Growing at 20-30% annually	Pricing stability or slight increase	Variable	Mature market, potential indication expansion

4.2 Cost Structure and Profitability

Cost Item	% of Revenue / Notes
R&D Expenses	Continued investment (~20-25%) during approval phase
Manufacturing Costs	~10-15%, economies of scale expected later
Marketing & Sales	Initial high (~30%), reducing to 15-20% post-market entry
Regulatory & Legal	5% (including patent maintenance, legal compliance)
Gross Margin	Estimated 70-80% post-commercialization

4.3 Investment Considerations

Factor	Impact	Status/Notes
Clinical Success	High impact on valuation and market confidence	Phase 3 data crucial
Regulatory Approval	Accelerates revenue streams	Pending, dependent on trial outcomes
Competitive Landscape	Market share capture depends on differentiation and efficacy	Potential entrants or pipeline advancements
Pricing & Reimbursement	Critical for revenue realization	Payer negotiations, health economic data

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5. Comparative Analysis with Similar Biotech Assets

Asset	Disease Area	Development Stage	Peak Sales (USD millions)	Key Differentiator
Tezspire (Tezepelumab)	Severe asthma	Approved	~$1,200 by 2022	Monoclonal antibody targeting TSLP pathway
PulmoBioNexus (Invested)	Rare respiratory diseases	Phase 2	N/A	Novel inhaled delivery systems
Brensocatib	Bronchiectasis, inflammation	Phase 3	Estimated 2025+	Small molecule oral DPP1 inhibitor

Insight: Brensocatib’s trajectory aligns with other niche respiratory therapies with high unmet need, promising robust revenue if clinical and regulatory milestones are achieved.

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6. Risks and Opportunities

Risks	Mitigation Strategies
Clinical trial failure	Robust Phase 3 design, adaptive protocols
Competitive innovations	Patents, strategic partnerships
Regulatory delays	Early engagement, comprehensive data packages
Market acceptance and reimbursement hurdles	Stakeholder engagement, health economics studies

Opportunities	Strategic Actions
Expanding indications	Conduct trials for additional inflammatory diseases
Partnership or licensing deals	Monetize via collaborations with larger pharma
Market expansion beyond US/EU	Focus on emerging markets with high unmet needs

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7. Conclusion

Brensocatib represents a promising asset in the niche of inhaled anti-inflammatory agents targeting neutrophil elastase activation. Its success hinges on Phase 3 efficacy data, regulatory approval, and market access strategies. Market potential exceeds USD 2 billion annually, with upside from indication expansion. Strategic investment should consider the outcome of ongoing trials, competitive dynamics, and reimbursement policies.

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Key Takeaways

• Brensocatib’s novel mechanism positions it as a differentiated treatment option within inflammatory respiratory diseases.
• The dominant market for bronchiectasis and COPD presents significant revenue potential, contingent on successful commercialization.
• Investing in brensocatib carries typical biotech risks, notably clinical and regulatory risks, mitigated through strategic partnerships.
• Market dynamics favor early adoption if efficacy and safety are established, especially given current unmet medical needs.
• Financial projections indicate substantial revenue growth beginning in 2024, with toxicity and reimbursement landscapes influencing long-term profitability.

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5. FAQs

Q1: What is the current clinical development stage of brensocatib?
A1: As of 2023, brensocatib is in Phase 3 clinical trials, primarily targeting bronchiectasis, with a pivotal data readout expected soon.

Q2: How does brensocatib compare with existing therapies?
A2: Unlike antibiotics and biologics, brensocatib offers a small molecule, orally administered approach aimed at reducing neutrophil-driven inflammation, filling a gap in current therapeutic options.

Q3: What regulatory advantages does brensocatib have?
A3: It has received Orphan Drug Designation from the FDA and EMA, potentially enabling faster approval processes and market exclusivity extensions.

Q4: What are the main market barriers for brensocatib?
A4: Potential barriers include regulatory delays, reimbursement negotiations, and competing pipeline agents with different mechanisms.

Q5: When can investors expect to see actual revenue from brensocatib?
A5: Assuming regulatory approval occurs in late 2023 or early 2024, initial revenues could begin in 2024, with significant scaling by 2025-2026.

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References

[1] Insmed Incorporated. “Pipeline and Development Programs,” 2023.
[2] FDA, “Orphan Drug Designation for Brensocatib,” 2019.