BUTRANS Drug Patent Profile

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

Butrans is a drug marketed by Purdue Pharma Lp and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Butrans

A generic version of BUTRANS was approved as buprenorphine by WATSON LABS TEVA on November 20^th, 2018.

Summary for BUTRANS

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for BUTRANS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BUTRANS	Transdermal System	buprenorphine	15 mcg/hr	021306	1	2013-12-16
BUTRANS	Transdermal System	buprenorphine	5 mcg/hr 10 mcg/hr 20 mcg/hr	021306	1	2013-06-06

US Patents and Regulatory Information for BUTRANS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	AB	RX	Yes	No
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013	AB	RX	Yes	No
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	AB	RX	Yes	No
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	AB	RX	Yes	No
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	AB	RX	Yes	Yes

International Patents for BUTRANS

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

Country	Patent Number	Title	Estimated Expiration
Israel	116452
Australia	743071
Greece	3020177
Portugal	964677
Israel	214299	מערכת למתן טרנסדרמלי של בייופרנאורפין לשימוש לטיפול בכאב (Transdermal delivery systems of buprenorphine for use in treating pain)
Australia	2925402

Investment Scenario, Market Dynamics, and Financial Trajectory for BUTRANS (Bupivacaine and Butorphanol)

Last updated: February 3, 2026

Summary

BUTRANS (buprenorphine/transdermal system) is a transdermal patch primarily indicated for severe pain management. Its market position is influenced by evolving opioid prescription policies, the shift toward non-opioid analgesics, and regulatory challenges. This analysis outlines the current and projected investment landscape, key market dynamics, competitive positioning, and financial outlook for BUTRANS, emphasizing its strategic considerations and growth potential over the next decade.

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What Is the Current Market Position of BUTRANS?

Parameter	Details	Source/Notes
Product Type	Transdermal opioid analgesic	(FDA) 2010 approval
Indications	Chronic pain, cancer pain	Post-approval uses
Market Authorization	United States, Europe, other regions	Regulatory bodies
Main Competitors	Fentanyl patches, Xtampza ER, non-opioid alternatives	Market share varies
Pricing Point	~$70–$120 per patch (per week), depending on dosage	Market data

Market Share & Revenue (Approximate):

• Estimated global revenue of BUTRANS reached approximately $250 million in 2022, with a declining trend due to increasing opioid regulations and competitive pressure.

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Market Dynamics Impacting BUTRANS Investment Scenario

How Do Regulatory Policies Shape Market Opportunities?

Aspect	Impact	Details	Source
Regulatory Scrutiny	Tightening	Increased restrictions on opioid prescribing to curb misuse	FDA, EMA guidelines (2021-2023)
Generic Entry	Pendings	Generics emerging in markets like India, Europe	Recent patent expirations (2020)
Reformulation & Abuse-Deterrent Features	Enhancing viability	Development of abuse-deterrent formulations to meet regulatory standards	Industry trends (2022)

Market Trends and Patient Demographics

Trend	Impact	Details
Growing Pain Management Needs	Steady demand	Oncology, chronic pain populations
Opioid Crisis Impact	Reducing prescriptions	Regulatory limits, prescriber caution
Shift Toward Non-Opioid Alternatives	Competitive pressure	NSAIDs, nerve blocking agents

Market Penetration & Adoption Drivers

Factor	Influence	Details
Physician Preference	Moderate	Dependence on pain management protocols
Patient Acceptance	Variable	Concerns over opioid dependency
Reimbursement Policies	Critical	Coverage variance affects sales

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Financial Trajectory & Investment Outlook

Revenue Forecasts: 2023–2032

Year	Estimated Revenue (USD Millions)	Assumptions
2023	$230	Slight decline from previous year due to regulatory pressures
2025	$200	Competitive pressure increases, generic entries
2027	$180	Market saturation; decline in prescribing
2030	$150	Shift towards non-opioid modalities
2032	$130	Further erosion unless reformulation or new indications

Key Revenue Drivers

• Market Expansion in emerging markets (Asia-Pacific, Latin America) with increasing analgesic needs.
• Product Lifecycle Management involving new formulations or abuse-deterrent technologies.
• Partnerships and Licensing Agreements for regional distribution.

Cost Structure & Profitability

Parameter	Details	Source/Notes
Research & Development (R&D)	~$30–$50 million annually	Focus on reformulation, new delivery systems
Manufacturing & Distribution	Variable, economies of scale	Cost savings with higher volume
Gross Margin	Estimated 60–65%	Derived from current market prices
Net Margins	Approx. 15–20%	After R&D, marketing, admin expenses

Investment Risks and Opportunities

Risks	Details	Mitigation Strategy
Regulatory Barriers	Stricter opioid policies	Diversify pipeline and formulations
Market Competition	Generics and non-opioids	Invest in innovation, abuse-deterrent features
Supply Chain Disruptions	Global logistics issues	Strategic inventory management

Opportunities	Details	Action Points
Market Penetration in Emerging Regions	Growing healthcare infrastructure	Local partnerships, pricing strategies
Pipeline Expansion	Developing adjunct indications	Focus R&D on chronic pain and cancer pain
Reimbursement Improvements	Policy shifts favoring opioid management	Engage with payers early

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Comparison with Market Competitors

Drug	Type	Market Share (2022)	Price Range (USD)	Key Features
BUTRANS	Transdermal opioid	~25%	$70–$120/week	Long-acting, abuse deterrent (if reformulated)
Fentanyl Patch	Transdermal opioid	~40%	$80–$150/week	Established, high potency
Xtampza ER	Extended-release oxycodone	~10%	$15–$40/dose	Abuse-deterrent, non-transdermal
Non-Opioid Alternatives	Various	Remaining share	Varies	Growing acceptance

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Key Investment Considerations

• Patent Status & Lifecycle: Patent expiration in 2020 opened markets for generics, pressuring prices. New formulations could extend exclusivity.
• Regulatory Environment: Evolving policies require continuous compliance and innovation, with increased emphasis on abuse-deterrence.
• Market Acceptance: Clinician and patient adoption remain volatile due to concerns over opioid misuse. Education and evidence-based positioning are critical.
• Pipeline Development: Growth is linked to new indications, delivery systems, or abuse-deterrent properties to sustain competitive edge.
• Regional Expansion: Emerging markets offer growth avenues amidst saturated mature markets.

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FAQs

1. What are the primary factors influencing BUTRANS’s market share?

Regulatory restrictions on opioid prescribing, competition from generics, and advances in non-opioid pain management solutions are key factors. Public policy shifts and clinician preferences also shape adoption.

2. How does patent expiration impact BUTRANS’s revenue potential?

Patents typically protect formulations for about 10–12 years post-approval. With patent expiry in 2020, generic competition has eroded pricing and market share, emphasizing the need for reformulation or new indications to sustain sales.

3. What role do abuse-deterrent formulations play in the future of BUTRANS?

Abuse-deterrent formulations are crucial to meet regulatory standards, mitigate misuse, and regain prescriber confidence. Incorporation of abuse-deterrent features can prolong lifecycle and market viability.

4. Which emerging markets offer the most growth potential for BUTRANS?

Asia-Pacific and Latin American countries, characterized by expanding healthcare infrastructure and rising chronic pain prevalence, present significant growth opportunities with tailored pricing and regulatory strategies.

5. What are the main risks to investing in BUTRANS?

Major risks include regulatory clampdowns, commoditization via generics, declining prescriber interest, and shifts toward non-opioid therapies. Mitigation involves continuous innovation and market diversification.

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Key Takeaways

• Market Maturity & Patent Dynamics: The mature opioid market faces declining revenues post-patent expiration, necessitating innovation for sustained growth.
• Regulatory and Policy Shifts: Increasing restrictions challenge market expansion but also open doors for reformulated, abuse-deterrent products.
• Competitive Landscape: Strong presence of fentanyl patches and rising generics exert pricing pressure; differentiation through abuse-deterrence is vital.
• Emerging Market Opportunities: Rapid growth in Asia-Pacific and Latin America offers significant upside if effectively capitalized.
• Innovation & Pipeline Focus: Diversifying indications and developing next-generation formulations are critical to extend lifecycle and maintain investor interest.

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References

[1] FDA. "Buprenorphine Transdermal System (BUTRANS) Prescribing Information," 2010.
[2] IQVIA. "Pharmaceutical Market Data," 2022.
[3] Globally Harmonized System (GHS). "Opioid Prescription Policies," 2021.
[4] Industry Reports. "Pain Management Market Trends," 2022.
[5] Company Disclosures. "Pipeline and R&D Strategies," 2023.