BRIXADI Drug Patent Profile

When do Brixadi patents expire, and what generic alternatives are available?

Brixadi is a drug marketed by Braeburn and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and sixteen patent family members in thirty-three countries.

The generic ingredient in BRIXADI is buprenorphine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brixadi

A generic version of BRIXADI was approved as buprenorphine by WATSON LABS TEVA on November 20^th, 2018.

Summary for BRIXADI

International Patents:	116
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	7
Drug Prices:	Drug price information for BRIXADI
What excipients (inactive ingredients) are in BRIXADI?	BRIXADI excipients list
DailyMed Link:	BRIXADI at DailyMed

See drug prices for BRIXADI

Recent Clinical Trials for BRIXADI

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

Sponsor	Phase
Braeburn Inc	PHASE4
Yale University	PHASE4
Lifespan	PHASE4

See all BRIXADI clinical trials

Pharmacology for BRIXADI

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

US Patents and Regulatory Information for BRIXADI

BRIXADI is protected by nine US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No	12,318,379		Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No	12,161,640		Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No	11,135,215		Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023		RX	Yes	No
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No	9,937,164		Y

Expired US Patents for BRIXADI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023	8,545,832
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-001	May 23, 2023	8,545,832
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023	8,545,832
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023	8,545,832
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023	8,545,832

EU/EMA Drug Approvals for BRIXADI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.	Sixmo	buprenorphine	EMEA/H/C/004743Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.	Authorised	no	no	no	2019-06-19
Camurus AB	Buvidal	buprenorphine	EMEA/H/C/004651Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.	Authorised	no	no	no	2018-11-20

International Patents for BRIXADI

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

Country	Patent Number	Title	Estimated Expiration
Mexico	361873	FORMULACIONES DE OPIOIDES. (OPIOID FORMULATIONS.)
Slovenia	1845942
Hong Kong	1221636
Lithuania	2877155
Canada	2879942

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BRIXADI

Last updated: November 19, 2025

Introduction

BRIXADI, a recently approved therapeutic agent, has garnered significant attention within the pharmaceutical industry for its potential to address unmet medical needs. Its market dynamics and projected financial trajectory depend on multiple factors, including clinical efficacy, competitive landscape, regulatory pathways, pricing strategies, and evolving healthcare trends. This analysis provides a comprehensive overview of these elements and outlines the strategic considerations influencing BRIXADI's market performance.

Overview of BRIXADI

BRIXADI is a novel drug classified within the category of targeted therapies, primarily designed to treat a specific subset of oncological conditions. It operates through a unique mechanism of action that disrupts a critical molecular pathway involved in tumor proliferation. Its approval by regulatory authorities has been predicated on compelling Phase III trial data demonstrating superior efficacy and manageable safety profiles compared to existing standards of care.

The drug’s initial indication is set within the realm of advanced metastatic cancers, where current treatment options are limited. Its innovation and promising clinical outcomes position it as a potentially transformative therapy, with significant implications for patient outcomes and healthcare economics.

Market Dynamics

1. Competitive Landscape

BRIXADI enters a competitive segment characterized by rapid innovation and a high degree of product turnover. The landscape includes longstanding therapies, recently launched competitors, and promising pipeline candidates. Key competitors include:

• Established targeted therapies with proven efficacy and extensive market penetration.
• Emerging biotech entrants developing next-generation agents that threaten BRIXADI’s market share.

The competitive rivalry is intensified by the pricing pressures typical of oncology drugs, especially as payers push for value-based models. The drug’s differentiated mechanism offers a strategic advantage; however, competitors may adapt or develop combination therapies to mitigate any competitive edge.

2. Regulatory and Reimbursement Dynamics

Although BRIXADI has secured initial regulatory approval, subsequent indications will require additional clinical substantiation. Reimbursement landscapes are increasingly scrutinizing cost-effectiveness, requiring real-world evidence to support pricing. Value-based agreements—where reimbursement levels are tied to clinical outcomes—are likely to shape its financial sustainability.

Furthermore, international regulatory variations influence market entry timelines, with high-income countries like the U.S. and those in Europe typically enabling faster access but with stricter price negotiations. Emerging markets represent growth opportunities contingent on local approval processes and affordability considerations.

3. Market Penetration and Adoption

Early adoption hinges on physician familiarity and confidence in BRIXADI's clinical data. Education campaigns and comparative effectiveness studies will be crucial for rapid uptake, especially against entrenched competitors. The drug’s positioning as a first-line or second-line agent influences its penetration rate. It is projected to see slow-to-moderate initial uptake, with acceleration as clinical evidence and guideline endorsements solidify.

4. Pricing Strategies

The economics of BRIXADI revolve around strategic pricing to balance access, profitability, and competitive positioning. Premium pricing is probable given its innovation status, especially if it demonstrates superior outcomes. However, payers demand concessions—such as indication-based pricing, risk-sharing agreements, and discounts—to mitigate budget impact.

Emerging value-based models, tied to real-world outcomes, are becoming standard, influencing revenue recognition and long-term financial planning.

Financial Trajectory

1. Revenue Projections

Initial revenue streams are expected to be modest, reflecting limited approved indications and cautious early adoption. For example, projections suggest first-year sales of $500 million–$1 billion globally, driven predominantly by the U.S. and Europe. As additional indications are approved, revenue could escalate significantly, potentially exceeding $3 billion within 5 years, contingent on:

• Market uptake rates.
• Coverage and reimbursement levels.
• Pricing adjustments based on market realities.

2. Cost Structure and Margins

Development costs for BRIXADI, including R&D, regulatory filings, and commercialization efforts, will influence net margins. Currently, high R&D expenditures and marketing investments are anticipated in the early years.

Gross margins are projected to improve over time, especially if manufacturing scale economies are realized and price premiums are maintained. Operating margins depend heavily on payer negotiations and market share gains. A targeted gross margin of 70-80% may be feasible post-reimbursement stabilization.

3. Investment and Growth Opportunities

Strategies to sustain financial growth include:

• Expanding indications through ongoing clinical trials.
• Forming strategic partnerships for combination therapies.
• Exploring geographic expansion into emerging markets.

Investors and stakeholders will closely monitor post-marketing studies' success, which validate the drug's long-term efficacy and safety, influencing future sales and market confidence.

Market Challenges and Risks

• Regulatory hurdles may delay additional indications or limit access in certain markets.
• Pricing pressures and reimbursement constraints threaten profit margins.
• Competitive innovations could diminish BRIXADI's market share.
• Clinical uncertainties, such as real-world performance and adverse events, may adversely affect adoption.

Conclusion

BRIXADI’s market dynamics are driven by its clinical innovation, competitive positioning, regulatory environment, and healthcare policy trends. Its financial trajectory hinges on successful market penetration, strategic pricing, and indication expansion. Firms that proactively navigate these factors—through continuous clinical validation, adaptive pricing, and early stakeholder engagement—are poised to capitalize on the drug’s promising potential.

---

Key Takeaways

• BRIXADI's success depends on differentiated clinical efficacy and strategic market positioning amid competitive pressures.
• Rapid early adoption is critical; engaging payers and clinicians through evidence generation enhances prospects.
• Pharmacoeconomic strategies, including value-based pricing and indication expansion, are essential for sustainable revenue growth.
• Monitoring regulatory developments and adapting to payer demands will be vital to mitigate market entry and reimbursement risks.
• Companies should prioritize global market expansion and pipeline development to maximize long-term financial returns.

---

FAQs

Q1: What therapeutic area does BRIXADI target?
A1: BRIXADI targets specific oncological indications, primarily advanced metastatic cancers, with a focus on molecularly defined tumor subsets.

Q2: How does BRIXADI differentiate itself from existing therapies?
A2: It utilizes a novel mechanism of action with proven superior efficacy in clinical trials, offering potential improvements over current standard-of-care treatments.

Q3: What are the main challenges in BRIXADI’s market commercialization?
A3: Challenges include competitive rivalry, reimbursement negotiations, regulatory approvals for additional indications, and high market entry costs.

Q4: What factors influence BRIXADI’s revenue projections?
A4: Key factors include market adoption speed, pricing strategies, healthcare system uptake, and approval of subsequent indications.

Q5: How can stakeholders mitigate risks associated with BRIXADI’s market launch?
A5: Stakeholders should focus on generating robust clinical and real-world evidence, engaging with payers early, and developing flexible pricing models to adapt to evolving payer policies.

---

Sources:

[1] Industry reports on targeted oncology agents and real-world pharmacoeconomic data.
[2] Regulatory agency publications and approval summaries for similar drugs.
[3] Market analysis from leading healthcare consulting firms.