Brensocatib - Generic Drug Details

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.

One supplier is listed for this compound.

Summary for brensocatib

International Patents:	118
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
Patent Applications:	288
What excipients (inactive ingredients) are in brensocatib?	brensocatib excipients list
DailyMed Link:	brensocatib at DailyMed

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.

Recent Clinical Trials for brensocatib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Insmed Incorporated	PHASE2
Insmed Incorporated	PHASE1
Insmed Incorporated	Phase 1

See all brensocatib clinical trials

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	217673-002	Aug 12, 2025		RX	Yes	Yes	11,773,069		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	11,814,359			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	11,673,871		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	11,655,224		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes	12,201,638		Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes

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	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	PA2026513	Lithuania		PRODUCT NAME: BRINSUPRI - BRENSOKATIBAS; REGISTRATION NO/DATE: EU/1/25/1995 20251118
3097086	C20265009	Finland
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	2026C/712	Belgium		PRODUCT NAME: BRINSUPRI - BRENSOCATIB; AUTHORISATION NUMBER AND 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

Brenzocatib (formerly INS1007): Market dynamics and financial trajectory

Last updated: April 24, 2026

What is brensocatib’s commercial and competitive position?

Brensocatib is an oral, selective inhibitor of dipeptidyl peptidase 1 (DPP1) used in non-cystic fibrosis bronchiectasis and designed to reduce neutrophil elastase-mediated inflammation by blocking DPP1-dependent neutrophil activation.

From a market-structure standpoint, brensocatib sits in a crowded, payer-sensitive chronic-respiratory landscape where:

• Demand is driven by biomarker-defined patient subsets (neutrophil biology and exacerbation history) and guideline alignment rather than broad COPD-like indications.
• Competitive intensity comes from a mix of disease-modifying agents and supportive anti-infective approaches, with payers favoring drugs that reduce exacerbations and healthcare utilization.
• Uptake follows a specialist-led sales motion (pulmonology and bronchiectasis centers) with durable prescribing once patients demonstrate reduced exacerbation rates.

How has brensocatib’s indication-to-market path shaped sales?

Brensocatib’s revenue trajectory depends on the sequencing of approvals and labeling around:

• Indication definition (non-CF bronchiectasis with a history of exacerbations is the core commercialization anchor).
• Place in therapy (add-on to standard-of-care including airway clearance and infection management).
• Treatment effect durability (clinical endpoints are typically exacerbation counts and time-to-exacerbation rather than immediate symptom relief).

Commercial implication: brensocatib’s addressable market expands when labeling captures broader exacerbation histories or earlier lines of therapy, and compresses when payers narrow reimbursement through prior authorization criteria (exacerbation frequency thresholds, baseline sputum status, or failure of inhaled therapies).

What market dynamics drive adoption in bronchiectasis?

Key adoption determinants in non-CF bronchiectasis include:

1. Exacerbation burden
   Prescribers target patients at higher risk of repeat exacerbations because reimbursement and clinical value arguments tie to event reduction.

2. Specialist concentration and diagnostic lag
   Non-CF bronchiectasis is underdiagnosed relative to COPD. Once patients enter specialty care, treatment decisions cluster by center and region, creating uneven early uptake.

3. Payer scrutiny tied to utilization outcomes
   Value dossiers and budget impact models often focus on reduced emergency visits, hospitalizations, and antibiotic use.

4. Real-world tolerability and adherence
   Oral dosing supports adherence relative to inhaled biologics, but long-term adherence still depends on perceived benefit over multiple exacerbation cycles.

How does competition affect brensocatib pricing and volume?

Competitive dynamics in bronchiectasis and chronic airway inflammation typically produce:

• Pricing pressure when competitors offer overlapping claims in similar exacerbation-risk populations.
• Contracting leverage for managed markets using outcomes-based or restricted-access arrangements.

Brensocatib’s strategy is anchored to a differentiated mechanism (DPP1) and clinical endpoints that translate to fewer exacerbations, which can defend price if payers accept the clinical link between DPP1 inhibition and reduced healthcare utilization.

What is brensocatib’s financial trajectory (revenue, guidance, and runway)?

A complete financial trajectory requires current disclosed sales, geographic revenue splits, and management guidance. Those inputs are not provided here, and a precise, data-backed financial forecast cannot be produced without them.

What can be stated from a market-cashflow perspective without breaking financial precision?

Even without disclosed revenue figures, brensocatib’s financial trajectory in this market typically follows a pattern driven by:

• Launch and expansion phases: initial conversion in high-exacerbation cohorts, then growth as real-world evidence supports broader eligibility.
• Reimbursement learning curve: early denials and prior authorization friction often decline as payers update criteria and providers standardize documentation.
• Lifecycle risks: competition, payer tightening, and evolving guidelines can cap growth; successful outcomes evidence can extend duration of uptake.

What are the highest-impact commercial risks and their financial consequences?

1. Payer restriction risk
   If coverage criteria remain narrow (for example, high baseline exacerbation frequency), volume growth slows even if clinical efficacy holds.

2. Guideline positioning risk
   If major bronchiectasis guidelines emphasize other pathways, brensocatib can still grow but may underperform expectations on uptake speed.

3. Real-world effectiveness risk
   Real-world populations often show heterogeneity in infection burden, colonization patterns, and adherence to airway clearance. Reduced effect magnitude can erode payer confidence and provider enthusiasm.

4. Competitive substitution
   When competing therapies demonstrate similar reductions in exacerbations, managed care can force price concessions or channel shifts.

What investment-relevant milestones track brensocatib’s trajectory?

Commercial trajectory typically accelerates when at least one of these occurs:

• Expansion of label scope (broader eligible patient populations or additional settings).
• Strong post-marketing or real-world evidence confirming exacerbation reduction and tolerability.
• Evidence of durable effect across multiple exacerbation seasons, supporting payer confidence for longer authorization cycles.
• Hospital-system contracting that lowers friction for prior authorization.

What’s the revenue model: event reduction, contracting, and patient flow?

A practical way to model brensocatib commercialization in non-CF bronchiectasis is to treat revenue as a function of:

• Eligible patient pool size (diagnosed bronchiectasis and exacerbation history that meets criteria)
• Conversion rate from eligible patients to treated patients (depends on access, center adoption, and prescriber comfort)
• Persistency (cycle-to-cycle continuation depends on perceived reduction in exacerbations and side effects)
• Net price (driven by payer mix, rebates, and restricted access)
• Contract structure (outcomes-based components can change realized revenue per patient)

Business implication: in this setting, the growth ceiling often comes from eligible-pool and access constraints more than from pure clinical efficacy.

What is the current market outlook for DPP1 inhibition in respiratory inflammation?

Brensocatib’s outlook is tied to whether DPP1 inhibition becomes a recognized disease-modifying strategy in bronchiectasis rather than a niche option. Market acceptance generally depends on:

• Consistency of exacerbation reductions across diverse patient subgroups
• Integration into pulmonology pathways and center formularies
• Payer comfort with budget impact relative to exacerbation-related cost offsets

Key Takeaways

• Brensocatib’s market position is defined by specialist-led adoption in exacerbation-risk non-CF bronchiectasis, with payer decisions centered on exacerbation reduction and healthcare utilization impact.
• Adoption depends less on broad symptom claims and more on eligible-patient size, prior authorization friction, and persistency over multiple exacerbation cycles.
• Competitive intensity in chronic airway disease increases the probability of net price concessions and restricted access unless outcomes data sustain payer confidence.
• A fully numeric revenue and guidance trajectory cannot be stated from the provided information; the financial path is instead governed by label scope, payer criteria, contracting, and real-world effectiveness.

FAQs

1. What patient group drives brensocatib adoption in non-CF bronchiectasis?
   Patients with a history of exacerbations who fit payer and guideline-defined risk criteria.

2. What outcomes matter most to payers for brensocatib?
   Reduced exacerbations and downstream healthcare utilization (ER visits, hospitalizations, antibiotic use).

3. Does oral dosing improve commercial prospects versus inhaled or injectable therapies?
   It typically supports adherence and simplifies prescribing logistics, which can improve conversion and persistency.

4. What are the main variables that change net realized revenue for brensocatib?
   Managed care contracting, rebate structures, prior authorization criteria, and outcomes-based components.

5. What milestones most strongly correlate with faster revenue growth?
   Label or eligibility expansion, broad formulary access, and real-world evidence that confirms exacerbation reduction.

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References

[1] European Medicines Agency. [Product information for brensocatib (Cayston/INS1007 or equivalent)]. European public assessment report and product label documents.