BRIXADI Drug Patent Profile

Which patents cover Brixadi, and when can generic versions of Brixadi launch?

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

This drug has one hundred and fifteen 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. Nine 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:	115
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	3
Patent Applications:	3,749
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
University of Pennsylvania	Phase 2
New York State Psychiatric Institute	Phase 2
Harvard Medical School (HMS and HSDM)	Phase 2

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 seven 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	210136-006	May 23, 2023		RX	Yes	No			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023		RX	Yes	No			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No			Y

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/004743 Sixmo 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/004651 Treatment 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
Poland	1768650
Slovenia	1845942
Japan	2015522649	オピオイド製剤
Croatia	P20210068
European Patent Office	1848403	FORMULATIONS BIOADHESIVES TOPIQUES (TOPICAL BIOADHESIVE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2006075125
Japan	2008542437

BRIXADI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BRIXADI

Introduction to BRIXADI

BRIXADI, a buprenorphine extended-release injection, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD). This innovative medication, developed by Braeburn, offers both weekly and monthly dosing options, making it a significant addition to the treatment landscape for OUD.

Market Need and Demand

The opioid epidemic continues to be a major public health crisis, with over 82,000 people dying from opioid overdoses in the U.S. alone in recent years[2][4][5].

• This dire situation has created a high demand for effective and innovative treatments, making BRIXADI a timely and crucial addition to the market.
• The global OUD market is projected to grow from USD 3.62 billion in 2024 to USD 7.48 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 9.5% during the forecast period, driven by increasing regulatory support and growing engagement from governmental and non-governmental institutions[3].

Unique Selling Points of BRIXADI

• Dosing Flexibility: BRIXADI is the first and only injectable buprenorphine that offers both weekly and monthly dosing options, allowing healthcare providers to tailor treatment to individual patient needs[2][4][5].
• Initiation and Administration: It can be initiated on the first day of treatment after a test dose of oral buprenorphine, and it must be administered subcutaneously by healthcare providers in a healthcare setting[2][4][5].
• Clinical Efficacy: In a pivotal Phase 3 efficacy and safety trial, BRIXADI demonstrated non-inferiority and superiority over daily sublingual buprenorphine/naloxone (SL BPN/NX) in terms of responder rates and negative opioid assessments[2][5].

Regulatory Approval and Launch

• FDA Approval: BRIXADI received FDA approval in May 2023 for the treatment of moderate to severe OUD. This approval marked a significant step forward in addressing the opioid epidemic[4][5].
• Launch in the U.S.: The drug was launched in the U.S. in September 2023, available through a restricted distribution program called the Brixadi REMS Program, which requires healthcare providers to be certified before dispensing the drug[2][4][5].

Financial Performance and Projections

• Initial Sales and Revenue: Following its launch, BRIXADI generated its first royalty revenue of SEK 1.2 million for the first three weeks of sales in the U.S. This is a promising start, considering the drug's recent market entry[1].
• Milestone Payments: A significant milestone payment of USD 35 million from Braeburn to Camurus, the licensor of BRIXADI, contributed to a strong cash flow for Camurus, highlighting the financial potential of the drug[1].
• Market Penetration: The strong financial performance of Camurus, with total revenues increasing by 59% and product sales increasing by 44% compared to the previous year, indicates robust market penetration and growth prospects for BRIXADI[1].

Competitive Landscape

• Unique Positioning: BRIXADI's unique dosing options and its use of FluidCrystal® Injection Depot Technology set it apart from other buprenorphine products in the market[5].
• Comprehensive Treatment Plan: The drug is designed to be used as part of a complete treatment plan that includes counseling and psychosocial support, aligning with current treatment guidelines and enhancing its appeal to healthcare providers[2][4][5].

Patient Access and Affordability

• Cost and Accessibility: Most patients will pay $10 or less for BRIXADI, making it an affordable option. The drug is also available through Medicaid and increasingly through private payers, ensuring broader access to patients[4].
• Distribution and Reimbursement: Changes in reimbursement and distribution systems, such as those in Australia, may further enhance patient access to BRIXADI over time[1].

Future Growth and Expansion

• Global Market Approvals: Camurus plans to take late-stage pipeline programs, including BRIXADI, to global market approvals, indicating a potential for expanded market reach beyond the U.S.[1].
• Establishing Commercial Organization: The strong financial position of Camurus will enable the establishment of its own commercial organization in the U.S., further supporting the growth and distribution of BRIXADI[1].

Key Takeaways

• BRIXADI addresses a critical need in the treatment of OUD with its flexible dosing options and clinical efficacy.
• The drug's launch and initial sales indicate strong market potential and financial growth.
• Regulatory approvals, milestone payments, and expanding patient access are key drivers of its financial trajectory.
• The unique positioning of BRIXADI within the OUD treatment landscape sets it up for continued market penetration and growth.

FAQs

Q1: What is BRIXADI and how is it used? BRIXADI is a buprenorphine extended-release injection approved for the treatment of moderate to severe opioid use disorder (OUD). It offers both weekly and monthly dosing options and must be administered subcutaneously by healthcare providers[2][4][5].

Q2: What are the unique features of BRIXADI compared to other buprenorphine products? BRIXADI is the first and only injectable buprenorphine that offers both weekly and monthly dosing options. It uses FluidCrystal® Injection Depot Technology and can be initiated on the first day of treatment after a test dose of oral buprenorphine[2][4][5].

Q3: How has BRIXADI performed financially since its launch? Since its launch, BRIXADI has generated significant revenue, including a milestone payment of USD 35 million from Braeburn to Camurus. The initial royalty revenue from the first three weeks of sales in the U.S. was SEK 1.2 million[1].

Q4: What is the market outlook for BRIXADI and the OUD treatment market? The global OUD market is projected to grow significantly, with BRIXADI poised to capture a substantial share due to its unique features and strong clinical efficacy. The market is expected to grow from USD 3.62 billion in 2024 to USD 7.48 billion by 2032[3].

Q5: How accessible is BRIXADI to patients in terms of cost and distribution? BRIXADI is designed to be affordable, with most patients paying $10 or less. It is available through Medicaid and increasingly through private payers, ensuring broader access to patients. The drug is distributed through a restricted program requiring healthcare provider certification[4].

Sources

1. Camurus Interim Report for the Third Quarter 2023.
2. BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use CIII Is Now Available in the US.
3. Opioid Use Disorder Market to Reach $7.48 billion by 2032.
4. FDA clears Braeburn's long-acting Brixadi to treat opioid use disorder.
5. Braeburn's BRIXADI™ (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder.