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-one 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			Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015		RX	Yes	No			Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-002	Oct 23, 2015		RX	Yes	No

Expired US Patents for BELBUCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015

International Patents for BELBUCA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1131344	TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE
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
Australia	2019202602	Transmucosal drug delivery devices for use in chronic pain relief

Market Dynamics and Financial Trajectory for BELBUCA

Last updated: February 19, 2026

What is BELBUCA?

BELBUCA (buprenorphine buccal film) is an opioid medication indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is a product of BioDelivery Sciences International, approved by the FDA in 2015.

Regulatory Status and Approved Uses

Year	Regulatory Action	Details
2015	FDA Approval	For pain management
2020	REMS Program	Implementation for abuse deterrence

BELBUCA is approved for both opioid-tolerant and non-tolerant patients in some jurisdictions, with restrictions due to abuse potential.

Market Size and Demand Drivers

Metric	2022 Estimate	Source/Notes
Global chronic pain market	$70 billion	Expected CAGR of 6% through 2027 (Grand View Research)
U.S. opioid medication market	$22 billion	Dominates due to high prevalence of pain conditions

Factors affecting demand include increasing chronic pain prevalence, rising opioid prescriptions, and regulatory changes prompting development of abuse-deterrent formulations.

Competitive Landscape

Key Products

• Suboxone (buprenorphine/naloxone): Used for opioid dependence; competes with BELBUCA for some pain indications.
• Butrans (buprenorphine transdermal patch): Established alternative for chronic pain management.
• Formulation innovations: Abuse-deterrent features in products like BELBUCA affect market share dynamics.

Market Position

• BELBUCA is positioned as a lower-abuse-potential alternative to traditional opioids, capitalizing on abuse-deterrent properties.
• Competition intensifies as generics enter the market, influencing pricing and margins.

Revenue and Financial Performance

• BioDelivery Sciences screens BELBUCA as a core growth asset.
• 2022 sales estimated at approximately $70 million.
• Growth driven by increased physician adoption and expanded labeling.
• Margins improved post-2018 with enhanced manufacturing efficiencies.

Pricing and Reimbursement

Aspect	Details
Average Wholesale Price (AWP)	Approximately $50 per unit
Medicaid Reimbursement Rate	Reduced due to increased generic competition
Insurance Coverage	Favorable, especially with updated REMS and abuse-deterrent claims

Pricing strategies focus on balancing profitability with formulary inclusion.

Market Challenges and Risks

• Generic Competition: Patent expirations and biosimilar entries pressurize prices.
• Regulatory Risks: Changes in opioid prescribing policies and abuse-deterrent regulations could restrict sales.
• Legal Risks: Litigation related to opioid liability remains a concern for industry participants.

Financial Trajectory Outlook

Short-term (1-2 years):

• Sales expected to stabilize at $70–$80 million.
• Margins may improve with increased operational efficiencies and market penetration.

Medium-term (3-5 years):

• Potential for growth driven by new formulations, expanded indications, and regulatory favorable rulings.
• Revenue could approach $150 million if market expansion accelerates and competition is managed.

Long-term (>5 years):

• Growth constrained by patent cliffs and increasing generic competition.
• Possible decline unless pipeline innovations or adjacent indications emerge.

Strategic Factors

• Launch of next-generation abuse-deterrent formulations.
• Expansion into international markets where opioid regulations loosen.
• M&A activity targeting pain management portfolios.

Regulatory and Policy Impact

• CDC guidelines reducing opioid prescriptions may cap market growth.
• Reimbursement evolution favoring abuse-deterrent and extended-release products.
• Ongoing crackdown on illegal opioid distribution could influence prescription patterns.

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Key Takeaways

• BELBUCA operates within a regulated, competitive landscape dominated by demand for safer opioid options.
• Sales are sensitive to regulatory changes, generic entry, and prescribing practices.
• The drug's financial contribution remains modest but has growth potential amid formulation and regional expansion.
• Market risks include legal liabilities, policy restrictions, and pricing pressures.
• Future growth depends on innovation, market expansion, and navigating regulatory environments effectively.

FAQs

1. How does BELBUCA compare to other opioid pain medications in the market?
BELBUCA offers abuse-deterrent properties and a buccal film delivery method, which differentiates it from traditional formulations but faces competition from broader NSAIDs and other opioids with abuse-deterrent features.

2. What are the main barriers to BELBUCA's market expansion?
Patent expirations, generic competition, regulatory restrictions, and shifts toward non-opioid pain treatments limit growth potential.

3. How significant is the impact of abuse-deterrent features on BELBUCA’s sales?
Abuse-deterrent features improve safety profiles, making products more attractive for regulatory approval and formulary placement, positively influencing sales.

4. What factors could accelerate BELBUCA’s revenue growth?
New formulations, broader international markets, expanded indications, and favorable regulatory decisions.

5. What regulatory challenges could affect BELBUCA moving forward?
Potential restrictions arising from opioid prescribing guidelines and stricter enforcement of REMS programs aimed at reducing abuse.

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References

[1] Grand View Research. (2022). Pain management market size, share & trends analysis.
[2] FDA. (2015). FDA Approval of BELBUCA.
[3] BioDelivery Sciences. (2022). Annual Report.
[4] U.S. Department of Health and Human Services. (2023). Opioid prescribing guidelines and policies.