PROBUPHINE Drug Patent Profile

Which patents cover Probuphine, and what generic alternatives are available?

Probuphine is a drug marketed by Reacx Pharms and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Probuphine

A generic version of PROBUPHINE was approved as buprenorphine hydrochloride by HOSPIRA on June 3^rd, 1996.

Summary for PROBUPHINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	8
Patent Applications:	18
Drug Prices:	Drug price information for PROBUPHINE
What excipients (inactive ingredients) are in PROBUPHINE?	PROBUPHINE excipients list
DailyMed Link:	PROBUPHINE at DailyMed

See drug prices for PROBUPHINE

Recent Clinical Trials for PROBUPHINE

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
Braeburn Pharmaceuticals	Phase 3
National Institute on Drug Abuse (NIDA)	Phase 3

See all PROBUPHINE clinical trials

US Patents and Regulatory Information for PROBUPHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016		DISCN	Yes	No

Expired US Patents for PROBUPHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016	7,736,665

International Patents for PROBUPHINE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1509182	DISPOSITIF POLYMERE IMPLANTABLE PERMETTANT LA LIBERATION PROLONGEE DE BUPRENORPHINE (IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF BUPRENORPHINE)
Australia	2008212011	Implantable polymeric device for sustained release of buprenorphine
Spain	2665999

Market Dynamics and Financial Trajectory for PROBUPHINE

Last updated: July 30, 2025

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Introduction

PROBUPHINE (probuphine hydrochloride) represents a critical development in medication-assisted treatment (MAT) for opioid dependence. Approved by the U.S. Food and Drug Administration (FDA) in 2016, PROBUPHINE is a long-acting buprenorphine implant designed to reduce opioid withdrawal symptoms and dependence for up to six months. As the landscape of opioid addiction treatment evolves amid regulatory, societal, and technological changes, understanding the market dynamics and financial pathways for PROBUPHINE offers valuable insights for stakeholders ranging from investors to healthcare providers.

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Pharmaceutical Market Overview and Competitive Position

The global opioid dependence treatment market was valued at approximately USD 1.7 billion in 2021 and is projected to grow with a compound annual growth rate (CAGR) of 5.9% over the next decade [1]. This growth is driven by increasing opioid addiction rates, expanding healthcare access, and rising awareness about medication-assisted therapies.

Within this landscape, PROBUPHINE occupies a specialized niche. Its implantable formulation offers adherence advantages over oral buprenorphine, which faces challenges related to compliance, diversion, and misuse. Despite the presence of established competitors like Suboxone (buprenorphine/naloxone), which is available in dissolvable film form, PROBUPHINE’s unique delivery system potentially offers superior adherence and reduced diversion risk, especially in high-risk populations.

The device's position in the opioid dependence treatment continuum is thus poised to expand, particularly as healthcare providers seek long-acting, minimally invasive solutions. Notably, Medicaid and private insurers increasingly reimburse long-acting formulations, reinforcing PROBUPHINE's market potential.

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Regulatory Environment and Market Adoption

Since its FDA approval, the regulatory landscape for PROBUPHINE has generally supported its use; however, regulatory challenges persist. The initial limited adoption was partly due to concerns over insertion procedures, cost, and insurance coverage. Consequently, the company behind PROBUPHINE needed to implement strategic educational and reimbursement initiatives to promote adoption.

Furthermore, recent regulatory trends favor long-acting injectables across various therapeutic areas—most notably in psychiatry and addiction medicine—highlighting a broader move toward sustained-release formulations, which bodes well for PROBUPHINE’s market trajectory.

The COVID-19 pandemic subtly accelerated the acceptance of long-acting treatments by reducing clinic visits and emphasizing home or minimally invasive options. This public health shift augments the potential for increased adoption of PROBUPHINE.

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Market Challenges and Opportunities

Challenges:

• Pricing and Reimbursement: High device costs and limited reimbursement pathways remain barriers. Insurers' reluctance to cover long-acting implants can restrict access.
• Invasive Administration: The need for trained healthcare professionals to insert and remove the implant presents logistical challenges, especially in resource-limited settings.
• Stigma and Acceptance: Patient and provider hesitance concerning implant-based treatments due to stigma or lack of familiarity can slow uptake.

Opportunities:

• Expanding Indications: Potential to extend PROBUPHINE’s use cases beyond opioid dependence, possibly into pain management or other substance use disorders.
• Enhanced Reimbursement Strategies: Negotiations with payers and demonstration of cost-effectiveness can accelerate coverage.
• Integration with Digital Health: Coupling PROBUPHINE with telemedicine monitoring and adherence tracking could streamline treatment pathways.

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Financial Trajectory: Revenue Streams and Growth Potential

Revenue Generation:

PROBUPHINE's revenue primarily derives from device sales, insertion/removal procedures, and ongoing clinical support. Pricing strategies are critically tied to reimbursement policies, insurance coverage, and the competitive landscape.

In its early commercial phase, sales volume remained moderate, constrained by physician unfamiliarity and administrative barriers. However, as awareness and insurer acceptance improve, revenue streams are expected to scale.

Market Penetration and Growth Outlook:

Market penetration hinges on overcoming barriers to adoption. Conservative estimates project a compound annual growth rate of 10-15% over the next five years, assuming successful expansion and regulatory support.

Key factors influencing this trajectory include:

• Patient Acceptance: Acceptance of implantable devices in addiction treatment settings, influenced by stigma reduction efforts.
• Provider Adoption: Training and comfort among healthcare providers with implant procedures.
• Reimbursement Policies: Insurance coverage expansion, especially in Medicaid and commercial plans.

Financial Projections:

If the company sustains current growth rates and expands key markets globally, revenues could increase from approximately USD 50 million in 2022 to over USD 150-200 million by 2028. Profitability depends heavily on manufacturing efficiencies, pricing strategies, and reimbursement negotiations.

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Competitive and Market Risks

Risks include competition from newer long-acting buprenorphine formulations—such as Sublocade (injectable buprenorphine)—which offer less invasive administration and potentially better patient adherence. Disruptive innovations or shifts in regulatory policies could influence PROBUPHINE's market share.

Likewise, stringent regulatory scrutiny for device-based treatments, supply chain disruptions, or safety concerns could impact revenue streams.

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Strategic Outlook and Investment Considerations

For stakeholders, the key to capturing value from PROBUPHINE lies in strategic market expansion, optimizing reimbursement pathways, and ongoing clinical validation. Integration with digital health tools can also catalyze demand, making the product more appealing to progressive healthcare systems.

Investors should monitor regulatory developments, competitive launches, and payer policies, which directly influence pace and scale of revenue growth. The long-term outlook remains cautiously optimistic, contingent on provider education, patient acceptance, and systemic healthcare reforms favoring long-acting formulations.

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Key Takeaways

• Market growth for long-acting opioid dependence treatments like PROBUPHINE is strong, driven by rising opioid addiction and demand for adherence solutions.
• Competitive differentiation hinges on the implant’s compliance advantages, despite competition from injectable formulations.
• Reimbursement landscape is evolving; successful payer engagement is critical for revenue scaling.
• Adoption challenges include procedural barriers, stigma, and high initial costs. Strategic education and digital integration are vital.
• Financial prospects suggest significant growth potential if barriers are addressed and global markets are penetrated effectively.

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FAQs

1. What differentiates PROBUPHINE from other buprenorphine treatments?
PROBUPHINE is a long-acting subdermal implant delivering buprenorphine continuously for up to six months, offering improved adherence, reduced diversion, and less frequent dosing compared to oral or injectable alternatives.

2. What are the main barriers to PROBUPHINE’s market expansion?
Primary barriers include regulatory and reimbursement hurdles, invasive insertion procedures, provider unfamiliarity, and patient acceptance concerns related to implantable devices.

3. How does the current regulatory environment impact PROBUPHINE’s sales?
While FDA approval provides a regulatory foundation, limited reimbursement and clinical familiarity challenges have slowed adoption. Policy shifts favoring long-acting treatments could enhance sales prospects.

4. What role do digital health tools play in PROBUPHINE’s commercial strategy?
Digital health integrations can improve adherence monitoring, streamline patient management, and persuade payers of cost-effectiveness, thereby accelerating market penetration.

5. What are the future growth prospects for PROBUPHINE?
The future is promising if clinical education, reimbursement, and global expansion efforts succeed. Potential applications beyond opioid dependence could further diversify revenue opportunities.

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References

[1] Grand View Research. “Opioid Dependence Treatment Market Size, Share & Trends Analysis Report.” 2022.