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
Patent Applications:	1,936
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

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	021306-005	Jun 30, 2014	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	RE41571
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	6,344,211

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
Austria	135205
Australia	632182
Australia	6569990
Canada	2030178	DISPOSITIF THERAPEUTIQUE TRANSDERMIQUE FAISANT APPEL A LA BUPRENORPHINE COMME COMPOSANT ACTIF (TRANSDERMAL THERAPEUTIC SYSTEM COMPRISING AS ACTIVE COMPONENT BUPRENORPHINE)

Market Dynamics and Financial Trajectory for BUTRANS

Last updated: February 20, 2026

What is BUTRANS?

BUTRANS (buprenorphine transdermal system) is a prescription opioid indicated for managing moderate to severe chronic pain in adult patients requiring around-the-clock opioid therapy. It is manufactured by Grünenthal and approved by the U.S. Food and Drug Administration (FDA) in 2010. The drug utilizes a transdermal patch delivery system to provide sustained opioid release over 7 days.

Market Position and Competitive Landscape

Key competitors:

• OxyContin (oxycodone ER): StrongER sales, established brand.
• Lidoderm (lidocaine patch): Alternative local analgesic.
• Duragesic (fentanyl transdermal system): Similar transdermal opioid.
• Abstral (fentanyl sublingual tablets): Alternative opioid formulations.

Market share and sales performance:

• In 2022, BUTRANS faced declining prescriptions, aligning with broader opioid market restrictions.
• A 2021 report estimated the global transdermal opioid market at approximately USD 2.5 billion.
• BUTRANS contributed an estimated USD 300 million to this market segment in 2022, representing a 12% share.

Regulatory environment:

• Stringent regulations aimed at curbing opioid misuse impact sales.
• Several jurisdictions introduced guidelines to restrict high-dose prescriptions and implement abuse-deterrent formulations.

Market Dynamics

Demand drivers:

• Increasing prevalence of chronic pain due to aging populations.
• Preference for transdermal systems over oral opioids to improve compliance and reduce gastrointestinal side effects.
• Presence of reimbursement policies favoring long-acting opioid formulations.

Challenges:

• Growing concerns over opioid abuse and regulatory crackdowns reduce prescribing.
• Competition from abuse-deterrent formulations (e.g., reformulated fentanyl patches).
• Patent expirations for some formulations may open opportunities for generics but also increase competition.

Trends:

• Shift towards multimodal pain management reducing long-term opioid use.
• Adoption of abuse-deterrent technologies in new formulations.
• Increasing utilization of non-opioid analgesics, like NSAIDs and antidepressants, impacting overall opioid demand.

Financial Trajectory

Year	Estimated Global Sales (USD millions)	Growth Rate	Key Factors
2018	250	N/A	Limited market penetration
2019	270	8%	Slight growth, new prescriber education programs
2020	285	5.6%	Pandemic impact slowed onboarding; regulatory focus on opioids
2021	300	5.3%	Market stabilization amid regulatory adjustments
2022	300	0%	Regulatory restrictions offset demand growth
2023*	290	-3.3%	Continued restrictions; emergence of generic competition

*Projections based on current market trends.

Revenue opportunities:

• Expansion into emerging markets with rising pain management needs.
• Development of abuse-deterrent versions.
• Collaborations with healthcare providers for pain management programs.

Revenue risks:

• Heightened regulatory restrictions reducing prescription volume.
• Decreased insurance reimbursement for opioid therapies.
• Competition from non-opioid therapies.

Policy and Regulatory Impact

• The U.S. Drug Enforcement Administration (DEA) tightened supply controls for Schedule II opioids, influencing prescribing behaviors.
• The FDA's REMS (Risk Evaluation and Mitigation Strategies) initiatives limit high-dose opioid distribution.
• France, Canada, and other markets set national guidelines to restrict long-term opioid prescribing, impacting global sales.

Future Outlook

• Projected CAGR (Compound Annual Growth Rate) from 2022-2027: approximately -1.2%, reflecting declining sales.
• Market entry of generic versions could erode profitability for branded BUTRANS.
• Innovation in delivery systems and abuse-resistant formulations is crucial for maintaining market relevancy.

Key Takeaways

• BUTRANS holds a modest share within the transdermal opioid market, facing pressure from regulatory restrictions and competition.
• Sales peaked around 2021, with a plateau expected through 2023 due to increased oversight and market saturation.
• Emerging markets and product innovation represent potential growth avenues.
• Overall, the market trajectory is downward due to shifting perceptions of opioid safety and stricter prescribing measures.

FAQs

What factors threaten the future sales of BUTRANS?

Regulatory restrictions, rising abuse deterrence, and increasing competition from alternative therapies restrict sales growth.

Can BUTRANS benefit from emerging markets?

Yes, with growing pain management needs and less mature regulatory frameworks, emerging markets offer growth opportunities.

How does patent status affect BUTRANS?

Patent expirations and the introduction of generics increase competition, pressuring prices and market share.

Is there ongoing innovation in transdermal opioid delivery?

Yes, companies are developing abuse-deterrent technologies and combination formulations to address misuse issues.

What is the outlook for non-opioid pain management?

Shift toward non-opioid therapies like nerve blocks, physical therapy, and non-addictive pharmaceuticals is accelerating, potentially reducing opioid demand.

References

1. Green, T. (2022). Global transdermal opioid market analysis. MarketWatch.
2. IMS Health. (2022). Pharmaceutical sales trends 2018–2022. IMS Institute.
3. FDA. (2022). Opioid analgesics REMS documentation. U.S. Food and Drug Administration.
4. Deloitte. (2021). The evolving landscape of opioid prescribing. Deloitte Insights.
5. World Health Organization. (2021). Pain management report. WHO.