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	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013

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
Yugoslavia	47956
Norway	20151450
Norway	332248
Croatia	P930675	PROCESS FOR THE PREPARATION OF TRANSDERMAL THERAPEUTIC SYSTEM WITH BUPRENORPHINE AS AN ACTIVE SUBSTANCE
Hungary	1200599
European Patent Office	0792145	RESORPTION TRANSDERMIQUE DE PRINCIPES ACTIFS CONTENUS DANS DES MASSES SURFONDUES (TRANSDERMAL RESORPTION OF ACTIVE SUBSTANCES FROM SUPERCOOLED MASSES)
Hungary	206266	PROCESS FOR PRODUCING TRANSDERMAL THERAPEUTIC SYSTEM COMPRISING BUPENORPHINE AS ACTIVE INGREDIENT

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BUTRANS

Last updated: July 27, 2025

Introduction

BUTRANS (buprenorphine transdermal system) is a prescription opioid used primarily in managing severe pain, particularly in opioid-tolerant patients suffering from chronic pain conditions. Since its approval by the FDA in 2001, BUTRANS has established a notable position within pain management therapeutics. Its market dynamics are influenced by a complex interplay of regulatory policies, societal attitudes towards opioids, competitive landscape, and evolving treatment protocols. This article provides an in-depth analysis of these factors and projects the financial trajectory of BUTRANS in the current pharmaceutical environment.

Market Overview

Global Pain Management Market Landscape

The global pain management market was valued at approximately USD 70 billion in 2021, with a compound annual growth rate (CAGR) of around 4% projected through 2028 [1]. Opioid-based products, including transdermal systems like BUTRANS, constitute a significant segment due to their efficacy in severe pain management. However, it faces significant headwinds from rising concerns regarding opioid misuse, regulatory restrictions, and competition from non-opioid alternatives.

Therapeutic Niche and Positioning

BUTRANS caters to a specialized segment—patients with chronic, severe pain requiring consistent opioid delivery. Its transdermal patch offers steady plasma concentration, improving adherence and safety compared to oral formulations. As a Schedule III controlled substance, BUTRANS benefits from its potent analgesic effects, but its market penetration remains sensitive to regulatory controls.

Market Dynamics Influencing BUTRANS

Regulatory Environment

Regulatory scrutiny has intensified globally, especially in North America and Europe. The U.S. Drug Enforcement Administration (DEA) and the FDA have implemented tighter controls over opioid distribution, impacting prescriptions of products like BUTRANS [2]. While this curtails potential overprescription, it constrains market expansion. Additionally, regulatory agencies are increasingly emphasizing abuse-deterrent formulations, influencing the development and approval pipeline.

Societal and Ethical Factors

The opioid crisis has diminished societal acceptance of opioid therapies. Governments and healthcare providers increasingly prioritize non-opioid alternatives for pain management, thereby limiting growth prospects for traditional opioid patches. Payers and insurers are scrutinizing coverage policies, favoring multimodal and non-opioid approaches.

Competitive Landscape

The entry of new formulations—such as abuse-deterrent opioids, implantable devices, and non-opioid analgesics—has intensified competition. Key competitors include generic formulations of buprenorphine patches, as well as non-opioid therapies like nerve blocks, cannabinoids, and novel analgesic agents. Patent expirations of original formulations threaten market share, encouraging generic entries.

Technological Innovations

Advancements in drug delivery systems, including implantable devices and enhanced transdermal technologies, threaten to erode BUTRANS’s market share. Conversely, innovations focusing on abuse-deterrent mechanisms and improved adherence can create opportunities for differentiation.

Market Penetration and Prescribing Trends

Despite regulatory challenges, BUTRANS maintains a strong foothold in the niche severe pain segment, especially in Medicaid and Medicare populations in the U.S. The prescribing trend remains cautiously optimistic, driven by clinical guidelines favoring long-acting opioids in specific patient cohorts. However, prescribers’ hesitance due to regulatory and societal pressures constrains aggressive growth.

Financial Trajectory and Revenue Forecast

Historical Performance

Since its market introduction, BUTRANS has experienced a steady revenue stream, peaking around USD 250 million in 2015. Post-2016, revenues plateaued, with a modest decline observed in the wake of societal shifts and regulatory clamps, reportedly shrinking to approximately USD 150-180 million annually [3].

Factors Affecting Financial Outlook

• Patent and Market Exclusivity: The expiration of patents on original formulations in certain regions opens avenues for generics, impacting pricing power and margins.

• Pipeline and Formulation Advances: Opportunities to enhance the current product with abuse-deterrent features or new delivery systems could stabilize revenues.

• Market Penetration Efforts: Expansion into emerging markets or increasing adoption within targeted U.S. patient populations could offset declines elsewhere.

Projected Revenue Growth (2023-2030)

Considering the current environment, experts project a conservative CAGR of approximately 1-2% over the next decade for BUTRANS. The growth outlook hinges on several factors:

• Continued regulatory restrictions may suppress growth and accelerate patent cliffs.
• Adoption of companion technologies and formulations with abuse-deterrent features could provide a revenue uplift.
• Geographical expansion, particularly into Asia-Pacific markets with rising chronic pain prevalence, offers potential upside.

Projection Summary:

Year	Estimated Revenue (USD million)	Notes
2023	160–180	Stable, moderate growth
2025	165–185	Impact of patent expiry, market saturation begins
2030	170–195	Slight growth driven by innovation and market expansion

Challenges and Opportunities

Challenges

• Regulatory barriers reduce prescription volumes.
• Societal backlash diminishes prescriber willingness.
• Market saturation in developed nations.
• Generic competition pressures prices and margins.

Opportunities

• Development of abuse-deterrent formulations.
• Expansion into developing markets with increasing chronic pain prevalence.
• Combining BUTRANS with digital health solutions for adherence monitoring.
• Diversification into non-opioid analgesic systems.

Conclusion

The future financial trajectory of BUTRANS will be shaped predominantly by external regulatory pressures, societal attitudes, and technological innovation. While its established position offers a foundation, growth prospects depend heavily on adaptation strategies, such as developing abuse-deterrent formulations and entering emerging markets. A cautious, innovation-focused approach may stabilize revenue streams and provide pathways for incremental growth amidst a challenging environment.

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Key Takeaways

• Market share stabilization: Due to regulatory hurdles and societal concerns, BUTRANS’s growth prospects are moderate; strategic innovation is crucial.
• Impact of patent expirations: Generics may erode margins unless complemented by differentiation or new formulations.
• Emerging markets: High potential exists, notably in Asia-Pacific, where the burden of chronic pain is rising.
• Innovation opportunities: Abuse-deterrent formulations and digital health integration can rejuvenate demand.
• Regulatory navigation: Active engagement with policymakers and adherence to evolving guidelines will determine market access and financial viability.

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FAQs

1. What are the main factors influencing BUTRANS's market share today?
   Regulatory restrictions, societal attitudes towards opioids, competition from generics and non-opioid therapies, and advancements in drug delivery technology primarily influence its market share.

2. How will patent expirations affect BUTRANS’s revenue?
   Patent expirations typically lead to generic competition, reducing pricing power and potentially decreasing revenues unless the company develops new, differentiated formulations.

3. What role does innovation play in the future of BUTRANS?
   Innovation, especially in abuse-deterrent technology and digital adherence tools, is crucial for maintaining relevance and expanding market adoption amid a competitive and regulatory landscape.

4. Are emerging markets a viable growth avenue for BUTRANS?
   Yes. Growing prevalence of chronic pain conditions and expanding healthcare infrastructure present significant opportunities, particularly in the Asia-Pacific region.

5. What strategic actions can companies take to optimize BUTRANS’s financial trajectory?
   Investing in reformulations with abuse-deterrent features, exploring market expansion, partnering for digital health integrations, and establishing strong regulatory relationships are essential strategies.

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Sources:

1. MarketResearch.com, 2022
2. FDA Regulatory Guidelines, 2022
3. Industry Revenue Reports, 2022