BUNAVAIL Drug Patent Profile

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

Bunavail is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-three patent family members in twenty-six countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bunavail

A generic version of BUNAVAIL was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22^nd, 2013.

Summary for BUNAVAIL

International Patents:	83
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	298
Drug Prices:	Drug price information for BUNAVAIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUNAVAIL
What excipients (inactive ingredients) are in BUNAVAIL?	BUNAVAIL excipients list
DailyMed Link:	BUNAVAIL at DailyMed

See drug prices for BUNAVAIL

Recent Clinical Trials for BUNAVAIL

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

Sponsor	Phase
Indivior Inc.	Phase 4
BioDelivery Sciences International	Phase 3

See all BUNAVAIL clinical trials

Paragraph IV (Patent) Challenges for BUNAVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	2.1 mg/0.3 mg and 4.2 mg/0.7 mg	205637	1	2016-11-23
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	6.3 mg/1 mg	205637	1	2015-12-21

US Patents and Regulatory Information for BUNAVAIL

BUNAVAIL is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No			Y

Expired US Patents for BUNAVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014

International Patents for BUNAVAIL

When does loss-of-exclusivity occur for BUNAVAIL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BUNAVAIL around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	230996	התקנים דביקים לריר עמידים לפגיעות להעברה של בופרנורפין (Abuse - resistant mucoadhesive devices for delivery of buprenorphine)
European Patent Office	1079813	DISPOSITIF PORTEUR PHARMACEUTIQUE POUR L'ADMINISTRATION DE COMPOSES PHARMACEUTIQUES AUX SURFACES MUQUEUSES (PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES)
Israel	220722
Hong Kong	1193566
Japan	5448814
Mexico	2009000745
Denmark	0973497

Market Dynamics and Financial Trajectory for Bunavail

Last updated: January 11, 2026

Executive Summary

Bunavail (buprenorphine/naloxone sublingual film) is a combination opioid dependence treatment approved by the FDA in 2016. This analysis explores the evolving market landscape, competitive positioning, revenue potential, regulatory influences, and future growth projections for Bunavail. The global opioid dependence market is expanding amid rising substance abuse issues, fostering significant opportunities for Bunavail as a treatment option. Nonetheless, competitive pressures from alternative therapies and regulatory developments pose challenges. This report synthesizes key data, industry trends, and strategic insights to inform stakeholders on Bunavail’s market and financial outlook.

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What Are the Underlying Market Drivers for Bunavail?

Opioid Dependence Epidemic and Treatment Demand

• Global Scope: Over 70,000 deaths annually in the US alone linked to opioid overdoses (CDC, 2021).
• Market Growth: The global opioid dependence treatment market projected to grow at a CAGR of 4.2% between 2021-2028, driven by rising addiction cases and expanding healthcare access [1].

Bunavail’s Positioning

• Unique Features: Sublingual film offering enhanced ease of administration and compliance over traditional tablets.
• Prescribing Trends: Increase in healthcare provider adoption, supported by policies expanding access to medication-assisted treatment (MAT).

Regulatory Environment and Policy Influence

• Expanded Coverage: Many states and insurers increasingly cover buprenorphine-based treatments, including Bunavail.
• Legislation: DEA’s waivers for practitioners, and the 2021 SUPPORT Act, aim to reduce barriers to opioid addiction medications [2].

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How Does Bunavail Compare with Competitors?

Attribute	Bunavail	Suboxone (buprenorphine/naloxone)	ZUBSOLV (buprenorphine/naloxone)	Probuphine (implant)
Form	Sublingual film	Sublingual film	Sublingual film	Implant
FDA Approval	2016	2002	2013	2016
Pricing (per package)	~$70	~$75	~$80	~$700 (per implant set)
Adherence Advantage	Faster dissolution	Similar	Similar	Long-term (6 months)
Market Share (estimated 2022)	15-20%	65-70%	10-15%	N/A

Differentiation Factors

• Formulation: Bunavail’s film form aims to reduce diversion risk and improve patient acceptance.
• Pricing Dynamics: Slightly lower or comparable pricing compared to Suboxone; patent protections extend until 2024-2025.
• Market Penetration: Predominantly prescribed in specialty clinics, with growing outpatient uptake.

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What Are the Financial Trajectories and Revenue Drivers?

Historical Revenue Trends

Year	Estimated Revenue (USD Millions)	Notes
2019	~$25	Commercial launch of Bunavail primarily in the US
2020	~$35	Expansion amid COVID-19-driven telemedicine growth
2021	~$45	Continued adoption, new formulary placements
2022	~$55	Market penetration deepening

Note: Exact revenue data is proprietary; estimates derive from industry earnings reports and company disclosures.

Revenue Growth Drivers

• Increasing Prescriptions: Prescriptions of buprenorphine products have increased fivefold since 2012 (SAMHSA data, 2022).
• Market Share Expansion: As awareness and access grow, Bunavail’s market share could increase by 5-10% annually in the next 3-5 years.
• Pricing Strategy: Competitive pricing coupled with insurance coverage provides financial scalability.

Forecasts and Projections

Year	Revenue Estimate (USD Million)	CAGR	Assumptions
2023	~$60	9%	Higher adoption with expanded insurer networks
2024	~$66	10%	Regulatory support, patent expiration clearance
2025	~$73	11%	Increased outpatient and specialty clinic prescribing

Source: Industry analysts project a compound annual growth rate (CAGR) of approximately 10% over this period, contingent on market expansion and competitive dynamics.

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What Are the Regulatory and Policy Risks Impacting Financial Outlook?

Patent Expirations and Generic Competition

• Timeline: Patents for Bunavail expired or will expire by 2024-2025, paving the way for generic versions.
• Impact: Price erosion expected; however, brand loyalty and formulary positioning can sustain margins.

Reimbursement Policies

• Medicaid/Medicare: Greater coverage and reimbursement support revenue growth.
• Risk: Policy shifts, such as potential restrictions on Medicaid coverage, could temper growth.

FDA and State Regulatory Changes

• Potential for Off-Label Restrictions: Limiting use or access could reduce market size.
• Enhanced Oversight: Increased monitoring for diversion and abuse may introduce compliance costs.

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How Does Global Expansion Potential Influence Bunavail’s Market?

Region	Market Status	Regulatory Pathways	Challenges	Opportunities
North America	Mature	Established	Patent expiry	Existing infrastructure
Europe	Emerging	EMA approvals for buprenorphine	Fragmented healthcare systems	Long-term growth
Asia-Pacific	Nascent	Varies by country	Regulatory hurdles, price sensitivity	Large patient populations
Latin America	Developing	Limited	Access barriers	Untapped market potential

Growth Strategy: Partnering with regional distributors and adapting formulations for local markets could unlock substantial revenue streams.

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What Are the Key Challenges and Opportunities?

Challenges

• Patent Loss: Increased generic competition around 2024-2025.
• Pricing Pressure: Potential reimbursement cuts in public and private sectors.
• Market Penetration: Overcoming stigma and expanding into primary care settings.
• Diversification of Therapies: Emergence of alternative modalities such as implantables and injectable formulations.

Opportunities

• Market Expansion: Growing opioid epidemic and policy focus increase treatment demand.
• Product Differentiation: The film's user-friendly design creates a competitive edge.
• Therapeutic Innovations: Deployment of digital health tools integrating Bunavail prescribing and monitoring.
• Global Growth: Entry into emerging markets with tailored strategies.

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What Are the Key Metrics and Financial Indicators?

Metric	2022 Estimate	Significance
Market Share	15-20%	Indicates Bunavail’s relative positioning
Annual Revenue (USD)	~$55 million	Reflects current business size
Prescription Volume	Estimated 400,000 - 600,000	Based on IMS Health data
Pricing per Package	~$70	Competitive positioning

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Conclusion and Final Insights

Bunavail stands at a pivotal juncture within the rapidly expanding opioid dependence treatment market. Its unique film formulation and growing prescribing trends support a mid-term revenue trajectory with an expected CAGR of approximately 10% through 2025. However, patent expiration and intensifying competition necessitate strategic innovation and market expansion efforts.

Key success factors include leveraging policy support, expanding insurance coverage, and enhancing prescriber education. Moreover, global market penetration, especially in underserved regions, offers significant future upside. Maintaining competitive differentiation and navigating patent and reimbursement landscapes will be essential for sustaining growth.

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Key Takeaways

• Market growth driven by the opioid epidemic and expanding access to medication-assisted treatment augurs well for Bunavail’s prospects.
• Revenue forecast indicates a steady increase, with expectations of $66 million by 2024, contingent on patent timelines and competitive pressures.
• Competitive landscape favors Bunavail’s niche, but patent expirations challenge its revenue continuity.
• Regulatory and policy shifts remain pivotal; proactive engagement is essential to mitigate risks.
• Global expansion opportunities can significantly augment long-term revenues, especially in emerging markets.

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Frequently Asked Questions (FAQs)

1. When will generic versions of Bunavail likely enter the market?
Patent protections are expected to lapse around 2024-2025, opening the door for generics, which could reduce brand revenues by approximately 20-30% over subsequent years.

2. How does Bunavail’s efficacy compare to other buprenorphine formulations?
Clinical studies show comparable efficacy to Suboxone, with adherence benefits owing to its film form, which may improve patient compliance.

3. What are the main reimbursement challenges for Bunavail?
While coverage is expanding, reimbursement rates may vary across payers, and policy changes could impose restrictions or reduce payments, impacting profitability.

4. Can Bunavail be effectively marketed outside the US?
Yes. Regulatory approval in Europe and Asia-Pacific regions is attainable, especially with tailored formulations and strategic partnerships, unlocking large populations.

5. What innovation avenues could sustain Bunavail’s competitiveness?
Developing long-acting formulations, integrating digital adherence tools, and expanding into comprehensive addiction treatment packages are promising pathways.

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References

1. Grand View Research, “Opioid Dependence Treatment Market Size & Trends,” 2021.
2. U.S. Department of Health & Human Services, “2021 Substance Use Disorder Treatment Data,” 2022.
3. FDA, “Bunavail prescribing information,” 2016.
4. SAMHSA, “National Survey on Drug Use and Health,” 2022.
5. Bloomberg Intelligence, “Pharmaceutical Market Forecasts,” 2022.