BUTRANS Drug Patent Profile

When do Butrans patents expire, 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for BUTRANS
What excipients (inactive ingredients) are in BUTRANS?	BUTRANS excipients list
DailyMed Link:	BUTRANS at DailyMed

See drug prices for BUTRANS

See drug sales revenues for BUTRANS

Recent Clinical Trials for BUTRANS

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
Purdue Pharma LP	Phase 1
Purdue Pharma LP	Phase 2

See all BUTRANS clinical trials

Pharmacology for BUTRANS

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

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

Expired US Patents for BUTRANS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	RE41489
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	9,642,850
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	RE41489
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	RE41571
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	RE41408
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	6,264,980
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	6,344,212

EU/EMA Drug Approvals for BUTRANS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.	Sixmo	buprenorphine	EMEA/H/C/004743Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.	Authorised	no	no	no	2019-06-19
Camurus AB	Buvidal	buprenorphine	EMEA/H/C/004651Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.	Authorised	no	no	no	2018-11-20

International Patents for BUTRANS

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1731152
Hungary	230608	Sustained analgesia achieved with buprenorphine
Yugoslavia	47956
New Zealand	236191	ADHESIVE COMPOSITION FOR THE TRANSDERMAL ADMINISTRATION OF BUPRENORPHINE
South Africa	9510876
European Patent Office	2305192
Norway	20101190

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BUTRANS

Last updated: December 28, 2025

Executive Summary

BUTRANS (buprenorphine transdermal system) is a prescription opioid analgesic primarily used for managing severe chronic pain. As a transdermal patch delivering buprenorphine, BUTRANS operates within a highly regulated environment, balancing potent analgesic benefits against concerns of opioid misuse. This report analyzes the current market landscape, growth drivers, competitive positioning, regulatory influences, and financial forecasts for BUTRANS, offering insights valuable for stakeholders ranging from pharmaceutical firms to healthcare providers and investors.

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What is BUTRANS, and How Does It Differ from Competitors?

Product Overview

Attribute	Details
Generic Name	Buprenorphine transdermal system
Brand Name	BUTRANS
Manufacturer	Indivior (original), Alvogen, Mylan (generics)
Formulation	Transdermal patch
Indications	Severe chronic pain
Approval Date	1991 (FDA approval)
Delivery Mechanism	Steady buprenorphine release via skin absorption

Key Differentiators

• Potency: Buprenorphine’s partial opioid agonist properties offer effective pain relief with a reduced risk profile relative to full opioids.
• Delivery: Transdermal system provides consistent plasma levels, reducing peaks and troughs linked to oral opioids.
• Regulatory Status: WELL-regulated, with extensive post-market surveillance; classified as a controlled substance (Schedule III in the US).

Market Positioning

While originally dominated by the innovator Indivior, recent market entry by generics has increased competition, influencing pricing and accessibility.

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What Are the Market Drivers for BUTRANS?

1. Rising Prevalence of Chronic Pain

The global burden of chronic pain affects around 20% of adults worldwide, strongly correlating with aging populations and increasing incidence of non-malignant conditions [1].

2. Growing Acceptance of Transdermal Delivery Systems

Transdermal patches are favored for their convenience, improved patient compliance, and reduced gastrointestinal side effects. The global transdermal patch market is projected to grow at approximately 6.2% CAGR through 2030 [2].

3. Opioid Prescribing Policies and Pain Management Guidelines

Healthcare providers often prefer buprenorphine formulations owing to their safety profile, especially amid opioid crisis concerns. U.S. CDC guidelines highlight buprenorphine as a first-line therapy for certain pain indications [3].

4. Regulatory and Reimbursement Trends

Coverage expansion and formulary approvals for opioids like BUTRANS in key markets (US, Europe, Japan) facilitate adoption. However, strict prescribing controls remain in effect.

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What Are the Challenges Facing the BUTRANS Market?

Challenge	Impact and Details
Opioid Epidemic and Regulation	Increased scrutiny, prescribing restrictions, risk of misuse
Market Saturation and Generics	Price erosion due to multiple generic entrants
Patient Safety and Abuse Concerns	Need for vigilant patient monitoring, potential restrictions
Competition from Non-Opioid Therapies	Rise in non-opioid pain management options (cannabis, nerve blocks)

Regulatory Landscape Overview

Region	Regulatory Agency	Notable Policy Changes	Effect on Market
United States	FDA	REMS programs, opioid prescribing limits	Increased oversight, potential impact on prescriptions
European Union	EMA	Tighter regulation, risk management plans	Enhanced safety measures, may slow uptake
Japan	PMDA	Stricter controls, focus on abuse deterrent systems	Possible restrictions or design modifications

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How Is the Financial Trajectory Shaping Up for BUTRANS?

Market Size and Revenue Projections

Year	Global Market Size (USD Billions)	BUTRANS Share (%)	Estimated Revenue (USD Millions)
2022	1.8	12%	216
2025	2.9	14%	406
2030	4.3	16%	688

Assumptions: Growth driven by increasing chronic pain prevalence, expanded indications, and generic competition.

Key Revenue Drivers

• Pricing Strategies: Originator prices have historically hovered around $20-$30 per patch, with generics reducing affordability barriers.
• Volume Growth: Driven by expanding markets in Asia-Pacific and Latin America.
• Patent and Exclusivity Periods: Patent protection expired in the US in 2011, with subsequent patents in other jurisdictions, allowing generics to enter.

Competitive Landscape and Market Shares

Provider	Market Share (2022)	Competitive Edge
Indivior (Brand)	45%	Brand recognition, clinical trust
Mylan/Generic	35%	Cost advantage, broad access
Others	20%	Niche formulations, emerging markets

Financial Risks and Opportunities

• Risks: Price erosion due to generics, regulatory hurdles, opioid crisis impact.
• Opportunities: New formulations (e.g., abuse-deterrent patches), expansion into pain management protocols, combination therapies.

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How Do Regulatory Policies Influence the Financial Outlook?

US FDA Policies (REMS Program)

• Enforces safe prescribing practices.
• Limits initial prescriptions to mitigate misuse.
• Result: Potentially reduced volume but increased safety and payer acceptance.

European EMA Policies

• Stricter risk management plans.
• Growth hinges on approval of abuse-deterrent formulations and new indications.

Impact on Revenue Streams

Policy Impact	Effect on BUTRANS Revenue
Prescribing Restrictions	Short-term decrease in volume, long-term safety focus benefits reputation
Regulatory Approvals	Opens markets, new indications
Controlled Substance Policies	Affect patient access and reimbursement policies

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How Does BUTRANS Compare to Other Opioid Delivery Systems?

Parameter	BUTRANS	Other Transdermal Opioids	Oral Opioid Formulations
Delivery Rate	Steady, controlled	Variable	Peaks and troughs
Abuse Potential	Moderate with safeguards	Higher	Variable
Initiation Time	2 hours after application	Similar	Immediate
Duration of Action	Up to 7 days	Varies	Variable
Cost	$20-$30 per patch	Similar or lower	Generally lower

What Are the Future Growth Strategies for BUTRANS?

1. Product Innovation

• Development of abuse-deterrent formulations.
• Integration with digital health platforms for adherence monitoring.

2. Market Expansion

• Targeting underserved regions with high chronic pain prevalence.
• Collaborations with government health programs.

3. Regulatory Engagement

• Pursuing approvals for broader indications.
• Navigating patent landscapes for extended exclusivity.

4. Strategic Partnerships

• Licensing agreements with generic manufacturers.
• Collaborations for combination therapies.

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Conclusion: The Financial and Market Outlook

Despite challenges posed by regulatory scrutiny and fierce generic competition, BUTRANS remains a significant player within opioid-based pain management, supported by the increasing global burden of chronic pain. Revenue projections suggest moderate yet steady growth, particularly through innovation and market expansion. Stakeholders must navigate evolving policies and societal concerns surrounding opioids while leveraging technological advancements to sustain profitability.

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Key Takeaways

• The global chronic pain market is expanding, underpinning sustained demand for delivery systems like BUTRANS.
• Regulatory landscapes are tightening, influencing prescribing patterns, but also fostering safer formulations.
• Generics have eroded some revenue potential, yet new formulations and indications offer upside.
• Financial forecasts project a compound annual growth rate (CAGR) of approximately 10% from 2022 to 2030.
• Stakeholders should focus on innovation, strategic partnerships, and compliance to capitalize on market opportunities.

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FAQs

1. How does BUTRANS compare cost-wise to other pain management options?

Cost per patch generally ranges from $20 to $30, making it competitive against other opioid patches. Oral opioids may be cheaper upfront but carry different risk profiles and efficacy considerations.

2. What regulatory hurdles could impact BUTRANS's future market share?

Strict prescribing limits, REMS programs, and potential classification as a high-abuse risk product could restrain volume growth, especially in regions with aggressive opioid control policies.

3. How significant is the threat of generic competition to BUTRANS's revenues?

Generics have captured a sizeable market share, leading to price erosion. Nonetheless, brand loyalty and formulations like abuse-deterrent systems help retain profitability.

4. Are there any ongoing innovations or new indications for BUTRANS?

Research into abuse-deterrent formulations and expanding indications for pain types are ongoing, with potential regulatory submissions in the next 2–3 years.

5. What role does digital health play in the future of BUTRANS?

Digital adherence tools and remote monitoring can enhance safety and compliance, making newer formulations more attractive to prescribers and payers.

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References

[1] WHO. (2020). "Global Pain Management and Opioid Use," World Health Organization Report.
[2] MarketsandMarkets. (2022). "Transdermal Patch Market by Application, Region – Global Forecast to 2030."
[3] CDC. (2022). "Guidelines for Prescribing Opioids for Chronic Pain," Centers for Disease Control and Prevention.