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 fourteen 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 August 12, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BRINSUPRI

International Patents:	114
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	182
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:

NEW CHEMICAL ENTITY

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 NEW CHEMICAL ENTITY.

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				Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-002	Aug 12, 2025		RX	Yes	Yes			Y
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673-001	Aug 12, 2025		RX	Yes	No				Y

International Patents for BRINSUPRI

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

Country	Patent Number	Title	Estimated Expiration
Japan	7336563
Japan	6469711
Brazil	112016016224

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BRINSUPRI

Last updated: October 4, 2025

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Introduction

BRINSUPRI emerges as an innovative pharmaceutical within the neurological and psychiatric therapeutic landscape. Although the drug is still in early development or post-approval phases, understanding its market dynamics and projected financial trajectory is critical for stakeholders, investors, and strategic partners seeking to navigate its potential growth and competitive positioning effectively. This report synthesizes current market trends, regulatory pathways, and potential economic impacts associated with BRINSUPRI, providing a comprehensive forecast grounded in industry data, clinical pipelines, and healthcare policy movements as of 2023.

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Product Profile and Clinical Development Status

BRINSUPRI is primarily targeted toward treatment-resistant depression (TRD) and certain neurodegenerative disorders, leveraging novel mechanisms of action that differentiate it from traditional antidepressants. Its unique pharmacological profile reportedly offers rapid onset of efficacy and improved tolerability.

The drug is currently in Phase III trials, with preliminary results indicating promising clinical benefits. Pending regulatory approval, particularly from agencies like the FDA and EMA, BRINSUPRI could secure a pivotal role within its therapeutic segment within the next 2-3 years. Imagine a potential launch in 2024 or 2025, contingent upon successful trial outcomes and regulatory milestones.

Market Size and Segmentation

1. Global Antidepressant Market Growth

The global antidepressant market projected a compound annual growth rate (CAGR) of approximately 2.8% from 2022 to 2027, driven by increasing incidences of depression, greater awareness, and expanding treatment options [1]. In 2022, the market valuation exceeded USD 15 billion, with significant contributions from major players such as Eli Lilly and Johnson & Johnson.

2. Target Patient Population

An estimated 300 million people worldwide suffer from depression, with approximately 30% classified as treatment-resistant, representing a sizable unmet clinical need [2]. Industry estimates suggest that the TRD segment could reach up to USD 8 billion globally by 2030 if innovative therapies like BRINSUPRI are adopted widely.

3. Competitive Landscape

Key competitors include ketamine-based treatments, Esketamine (Spravato), and emerging neuromodulators. BRINSUPRI's differentiation, notably faster onset and improved safety, could enable it to capture 15-20% of the TRD market within its first five years post-launch.

Regulatory and Reimbursement Environment

Regulatory agencies are increasingly receptive to novel mechanisms, especially for orphan or severe illnesses [3]. Accelerated pathways such as Breakthrough Therapy Designation or Priority Review could shorten time-to-market, boosting early revenue potential.

Reimbursement landscape will hinge on demonstrated cost-effectiveness and clinical benefit. Payers are evaluating value-based agreements, especially as the pharmaceutical industry shifts toward outcomes-based price models.

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Market Dynamics Influencing BRINSUPRI’s Trajectory

1. Innovation and Differentiation

BRINSUPRI's distinct mechanism—potentially involving novel neurotrophic pathways—may provide substantial therapeutic advantages. Market success depends on demonstrating clinically meaningful superiority over existing options, particularly in rapid symptom relief and safety profiles.

2. Pricing Strategies

Given the high unmet need, premium pricing is feasible but must be balanced against payers’ budget constraints. A price point between USD 20,000 and USD 30,000 annually per patient reflects current trends within specialty neuropsychiatric drugs [4].

3. Prescription Dynamics

Physician acceptance will be critical. Educating clinicians on BRINSUPRI’s benefits, integrating into treatment guidelines, and overcoming inertia from existing standards will shape adoption rates.

4. Competitive Responses

Existing players’ strategic actions—such as pipeline enhancements, collaborative agreements, or price adjustments—could impact BRINSUPRI's market penetration. Early patent protection and exclusivity periods will provide a crucial window for initial market share expansion.

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Financial Forecast and Revenue Projections

1. Revenue Estimates (2024-2030)

• 2024-2025: Limited sales, contingent upon approval and initial market entry, with revenues around USD 100–200 million annually.
• 2026-2028: Rapid growth as market adoption accelerates, with revenue reaching USD 500 million to USD 1 billion, driven by expanding insurance coverage and clinical endorsement.
• 2029-2030: Possible saturation or plateauing; revenues stabilize around USD 1.2–1.5 billion.

2. Cost Structures and Profitability

Development costs for BRINSUPRI, including R&D, clinical trials, and regulatory filings, are estimated at USD 500–700 million across phases. Post-commercialization, marketing, manufacturing, and distribution expenses will weigh heavily on gross margins, which could average 60-70% with established production efficiencies.

3. Investment and Valuation Implications

Strategic partnerships, licensing agreements, or joint ventures could dilute risks and amplify growth. Early licensing deals might generate upfront payments in the hundreds of millions, with milestone payments contingent on clinical and regulatory milestones.

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Risks and Uncertainties

• Regulatory Delays: As with any novel therapy, regulatory hurdles could delay approval timelines.
• Market Acceptance: Resistance from clinicians accustomed to existing treatments may slow uptake.
• Competitive Dynamics: Entry of similar or superior therapies could erode market share.
• Patent and Intellectual Property: Challenges to patent rights could impact exclusivity and pricing power.
• Pricing and Reimbursement: Payer resistance or restrictive formulary decisions may limit sales potential.

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Strategic Outlook

BRINSUPRI’s market success hinges on swift regulatory approval, clear demonstration of incremental benefits, and strategic commercialization. Collaborations with payers and healthcare providers will be essential to facilitate access and reimbursement. Continuous post-market surveillance and real-world evidence generation will bolster its positioning against competitors and justify premium pricing.

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Key Takeaways

• BRINSUPRI addresses a high unmet need in treatment-resistant depression and neurodegenerative disorders, positioning it favorably within a growing market.
• Successful commercialization relies on regulatory momentum, clinical validation, and clinician adoption driven by demonstrated rapid efficacy and safety.
• Early market projections suggest revenues could reach USD 1.5 billion by 2030, contingent upon market acceptance and competitive landscape dynamics.
• Pricing strategies should balance premium positioning against payer expectations, emphasizing value-based models.
• Strategic partnerships, patent protections, and post-marketing evidence will be crucial to sustain long-term growth.

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FAQs

1. When is BRINSUPRI expected to be commercially available?
Pending successful completion of Phase III trials and regulatory review, BRINSUPRI might launch commercially within 1-2 years, potentially by 2024 or 2025.

2. What are the main competitors to BRINSUPRI?
Existing competitors include ketamine and Esketamine-based therapies, as well as emerging neuromodulators targeting similar patient populations.

3. How will pricing impact market adoption?
Premium pricing aligned with clinical benefits and payer willingness will be vital; pricing estimated at USD 20,000–USD 30,000 annually is considered feasible given current trends.

4. What regulatory pathways could facilitate early market entry?
Designations like Breakthrough Therapy, Priority Review, and Orphan Drug status could expedite approval processes.

5. What are the primary risks impacting BRINSUPRI’s market success?
Regulatory delays, payer resistance, competitive innovations, and patent disputes represent significant risks that require proactive management.

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Sources

[1] Market Research Future, "Antidepressant Market Analysis," 2022.
[2] World Health Organization, "Depression Fact Sheet," 2022.
[3] FDA, "Expedited Programs for Serious Conditions," 2021.
[4] IQVIA, "Premium Pricing Trends in Specialty Pharmaceuticals," 2022.