BELBUCA Drug Patent Profile

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

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

This drug has seventy-six patent family members in twenty-seven countries.

The generic ingredient in BELBUCA 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 Belbuca

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

Summary for BELBUCA

International Patents:	76
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	9
Patent Applications:	18
Drug Prices:	Drug price information for BELBUCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELBUCA
What excipients (inactive ingredients) are in BELBUCA?	BELBUCA excipients list
DailyMed Link:	BELBUCA at DailyMed

See drug prices for BELBUCA

Recent Clinical Trials for BELBUCA

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

Sponsor	Phase
Carolinas Pain Institute	Phase 4
BioDelivery Sciences International	Phase 4
Medical College of Wisconsin	Phase 2

See all BELBUCA clinical trials

Pharmacology for BELBUCA

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Paragraph IV (Patent) Challenges for BELBUCA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELBUCA	Buccal Film	buprenorphine hydrochloride	75 mcg and 150 mcg	207932	1	2016-10-24
BELBUCA	Buccal Film	buprenorphine hydrochloride	300 mcg, 450 mcg, 600 mcg and 750 mcg	207932	1	2016-10-04
BELBUCA	Buccal Film	buprenorphine hydrochloride	900 mcg	207932	1	2016-09-12

US Patents and Regulatory Information for BELBUCA

BELBUCA is protected by three 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	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015		RX	Yes	No	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015		RX	Yes	No	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	9,901,539

Expired US Patents for BELBUCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015	7,579,019

International Patents for BELBUCA

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

Country	Patent Number	Title	Estimated Expiration
China	103550136	Transmucosal delivery devices with enhanced uptake
European Patent Office	2054031
New Zealand	574361

Market Dynamics and Financial Trajectory of BELBUCA

Last updated: November 21, 2025

Introduction

BELBUCA (buprenorphine) extended-release sublingual film, approved by the U.S. Food and Drug Administration (FDA) in 2015, addresses opioid dependence and chronic pain management. As a formulation of buprenorphine, a partial opioid agonist, BELBUCA offers a unique pharmacological profile aimed at reducing abuse potential and improving patient outcomes. Its market trajectory reflects evolving opioid epidemic policies, regulatory landscapes, and competitive dynamics. This analysis explores these elements to outline BELBUCA’s current market landscape and future financial prospects.

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Market Landscape Overview

Epidemiology and Demand Drivers

The surge in opioid addiction, driven by overprescription and illicit use, spurred demand for medication-assisted treatment (MAT). The CDC reports over 100,000 drug overdose deaths in the U.S. in 2021—a figure illustrating the urgency for effective opioid dependence therapies [1]. BELBUCA competes within this context, targeting a niche that benefits from its extended-release formulation, patient adherence, and perceived lower abuse potential.

Regulatory Environment Impact

Regulatory agencies, notably the FDA and DEA, exert significant influence on the opioid treatment market. The approval of BELBUCA was aligned with strict guidelines to mitigate abuse, including its schedule III classification. Federal and state-level policies increasingly favor medications with abuse-deterrent features; thus, the regulatory landscape both constrains and enables BELBUCA’s market expansion.

Competitive Dynamics

BELBUCA faces competition from buprenorphine formulations like Suboxone (buprenorphine/naloxone), Probuphine (buprenorphine implant), and Sublocade (extended-release injectable buprenorphine). While Suboxone remains dominant due to established prescribing patterns, BELBUCA’s extended-release film offers advantages in ease of administration and potentially reduced diversion risk, signaling a strategic differentiation.

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Market Adoption and Clinical Positioning

Physician and Patient Acceptance

Despite clinical advantages, adoption hinges on prescriber familiarity and patient acceptance. Belbucca’s sublingual film formulation is simpler compared to traditional sublingual tablets or injections. However, prescriber resistance persists due to entrenched preferences for existing medications and concerns over formulary inclusion.

Insurance and Reimbursement Landscape

Reimbursement challenges impact financial performance. Healthcare payers scrutinize the cost-benefit profile, with coverage often favoring generics and established formulations. BELBUCA’s premium pricing limits accessibility unless offset by demonstrated clinical benefits or tight regulatory controls.

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Financial Trajectory Analysis

Historical Performance and Revenue Trends

Since its launch, BELBUCA’s revenue has remained modest. Industry reports indicate that its annual sales grossed approximately $20 million in 2021, reflecting limited market penetration [2]. The product’s revenue growth is constrained by factors such as competition, prescribing hesitations, and regulatory hurdles.

Revenue Drivers and Limiters

• Pricing: Higher than generic buprenorphine options restrict volume growth.
• Market Penetration: Limited physician adoption and reach inhibit scaling.
• Regulatory Barriers: Ongoing scrutiny over opioid-related treatments influences prescribing patterns.
• Formulation Advantages: Its abuse-deterrent properties and ease of use offer growth prospects if supported by provider education.

Future Revenue Projections

Industry projections anticipate slow growth over the next five years, barring significant shifts in policy or clinical guidelines. A conservative estimate posits annual revenues increasing to $50 million by 2028, driven by expanded coverage, increased physician familiarity, and potential formulary inclusion. However, competitive pressures and payer rejection could temper this growth trajectory.

Potential Market Expansion Opportunities

Emerging markets beyond the U.S., including Canada and select European countries, demonstrate rising therapy adoption, potentially diversifying BELBUCA’s revenue streams. Additionally, expanding indications such as chronic pain management—pending further regulatory and clinical validation—could broaden its market scope.

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Key Market Forces Impacting Financial Trajectory

• Opioid Epidemic and Regulatory Response: Strict prescribing policies limit overall opioid use but increase demand for approved MAT options.
• Competitive Landscape: Dominance of generic formulations and newer integrated delivery systems challenges BELBUCA’s growth.
• Reimbursement Models: Transition toward value-based care pressures pricing strategies.
• Innovations in Delivery: New formulations with abuse-deterrent features may erode BELBUCA’s market share if they offer superior benefits.

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Strategic Considerations

To strengthen its market position and improve financial trajectory, the manufacturer must focus on:

• Expanding prescriber education, emphasizing BELBUCA’s abuse-resistant features.
• Engaging with payers to facilitate favorable formulary inclusion.
• Differentiating through clinical data supporting improved adherence or outcomes.
• Exploring international markets with unmet needs.

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Conclusion

BELBUCA's market dynamics are influenced by a confluence of epidemiological trends, regulatory actions, competitive pressure, and reimbursement policies. Its modest current revenues reflect market resistance and stiff competition; however, its unique features position it for incremental growth if strategic barriers are addressed. The product’s financial trajectory hinges on effective differentiation, expanding prescriber adoption, and favorable reimbursement frameworks.

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Key Takeaways

• Market landscape favors medications supporting opioid dependence treatment but faces constraints from entrenched generics and reimbursement issues.
• BELBUCA’s differentiation lies in its abuse-deterrent, extended-release formulation, offering potential advantages amidst a shifting regulatory focus.
• Revenue prospects remain cautiously optimistic; substantial growth requires expanded access, prescriber education, and payer acceptance.
• Competition from established buprenorphine products and emerging abuse-deterrent formulations presents ongoing challenges.
• International opportunities could diversify revenue, especially where opioid dependency treatments are underserved.

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FAQs

1. How does BELBUCA compare with other buprenorphine formulations in terms of market share?
BELBUCA occupies a niche segment with relatively low market share compared to dominant products like Suboxone, primarily due to limited prescribing patterns, reimbursement issues, and clinical familiarity.

2. What are the main barriers to BELBUCA’s wider adoption?
Barriers include high treatment costs, payer restrictions, prescriber hesitations, and competition from long-standing generics with more extensive coverage.

3. Does BELBUCA have advantages over other formulations in preventing abuse?
Yes, its abuse-deterrent extended-release film provides a milestone over traditional formulations, reducing diversion risk, although skepticism remains about its overall impact on abuse reduction.

4. What strategies could enhance BELBUCA’s market penetration?
Focused prescriber education, cost reduction, enhancing formulary access, and clinical evidence demonstrating superior adherence could drive wider adoption.

5. Are there upcoming regulatory or clinical developments that could influence BELBUCA’s future?
Further clinical trials, approval for additional indications, or regulatory incentives promoting abuse-deterrent opioids could positively impact BELBUCA’s prospects.

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References

[1] CDC, “Drug Overdose Deaths,” 2022.
[2] IQVIA, “Pharmaceutical Market Data,” 2022.