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. Nine 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:	19
Clinical Trials:	5
Patent Applications:	3,749
Drug Prices:	Drug price information for BUTRANS
Drug Sales Revenues:	Drug sales revenues 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

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

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/004743 Sixmo 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/004651 Treatment 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
Norway	332248
Finland	100379
Portugal	964677

BUTRANS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Butrans (Buprenorphine)

Introduction to Butrans (Buprenorphine)

Butrans, a brand name for the drug buprenorphine, is a potent opioid used for the management of severe, chronic pain and for the treatment of opioid use disorder. Here, we delve into the market dynamics and financial trajectory of Butrans, highlighting key drivers, challenges, and future projections.

Market Size and Growth Projections

The global buprenorphine market, which includes Butrans, is experiencing significant growth. As of 2023, the market size was valued at approximately USD 5.44 billion and is expected to exceed USD 31.27 billion by 2036, with a Compound Annual Growth Rate (CAGR) of over 14.4% during the forecast period of 2024-2036[1][4].

Growth Drivers

Several factors are driving the growth of the buprenorphine market, including:

Increasing Prevalence of Chronic Pain and Opioid Use Disorder

The rising incidence of chronic pain disorders and opioid use disorder is a major driver. According to the World Health Organization (WHO), cancer, which often involves chronic pain, is a leading cause of deaths worldwide, accounting for about 10 million deaths in 2020[1].

Government Investments in Healthcare

Escalating government investments in healthcare, particularly in developed nations, are also boosting market growth. These investments include support for opioid treatment programs and the approval of new buprenorphine formulations[1][4].

Approval of New Formulations

Regulatory approvals for new buprenorphine products, such as Brixadi (buprenorphine) extended-release injection, are expanding treatment options and increasing market demand. For instance, the U.S. Food and Drug Administration approved Brixadi for subcutaneous use to treat moderate to severe opioid use disorder in May 2023[4].

Route of Administration

Butrans, specifically, is a transdermal patch formulation of buprenorphine. The transdermal segment, while not the largest, is significant due to its effectiveness and patient preference. However, the sublingual segment is anticipated to hold the largest share in the buprenorphine market due to its rapid drug absorption and quick onset of action[1].

Geographical Analysis

North America is expected to dominate the buprenorphine market, driven by a strong presence of market players and a high percentage of the population suffering from opioid dependency. The region holds approximately 45.1% of the global market share, with increasing prescriptions of buprenorphine contributing to this dominance[1][4].

Economic and Health Outcomes

Offering buprenorphine, such as Butrans, in healthcare settings can have significant economic and health benefits. Studies have shown that while buprenorphine treatment may not be cost-saving, it is cost-effective, reducing healthcare and incarceration costs over time. For example, a study in Massachusetts indicated that shelter-based buprenorphine treatment could save $21.8 million in healthcare costs and $5.4 million in incarceration costs over 10 years[2].

Competitive Landscape

The launch of generic versions of Butrans, such as the one by Amneal following FDA approval, is expected to increase market competition and affordability. Amneal's generic Butrans, approved in April 2020, expands access to this critical medication, particularly for patients requiring long-term opioid treatment for severe pain[5].

Financial Performance

The financial performance of Butrans and similar buprenorphine products is robust. For instance, U.S. annual sales for Butrans were approximately $225 million for the 12 months ended February 2020, according to IQVIA™ data[5].

Challenges

Despite the growth, the buprenorphine market faces challenges, including:

Regulatory Hurdles

While regulatory approvals are a driver, they can also be a challenge. The process of obtaining FDA approval for new formulations can be lengthy and costly.

Competition from Generics

The entry of generic versions can reduce the market share of branded products like Butrans, affecting revenue.

Public Health Concerns

The opioid epidemic and associated public health concerns can lead to stringent regulations and public scrutiny, which may impact market dynamics.

Key Takeaways

• The global buprenorphine market, including Butrans, is projected to grow significantly, driven by increasing chronic pain and opioid use disorder prevalence.
• Regulatory approvals and government investments are key drivers.
• North America is expected to dominate the market due to high opioid dependency rates.
• Economic and health outcomes of buprenorphine treatment are favorable, despite initial costs.
• The launch of generic versions will increase competition and affordability.

FAQs

1. What is the expected market size of the global buprenorphine market by 2036? The global buprenorphine market is expected to exceed USD 31.27 billion by 2036[1].

2. What is the primary use of Butrans (buprenorphine)? Butrans is primarily used for the management of severe, chronic pain and for the treatment of opioid use disorder[5].

3. Which region is expected to dominate the buprenorphine market? North America is expected to dominate the buprenorphine market due to a strong presence of market players and high opioid dependency rates[1][4].

4. How does the launch of generic versions impact the market? The launch of generic versions increases competition and affordability, potentially reducing the market share of branded products like Butrans[5].

5. What are the economic benefits of buprenorphine treatment? Buprenorphine treatment can save healthcare and incarceration costs over time, despite initial treatment costs being higher[2].

Cited Sources:

1. Research Nester. Buprenorphine Market Size & Share, Growth Trends 2036.
2. JAMA Network. Health and Economic Outcomes of Offering Buprenorphine in Shelters.
3. Business Research Insights. Buprenorphine Hydrochloride Market Size, Share, Forecast 2031.
4. Coherent Market Insights. Buprenorphine Market Size, Trends and Forecast to 2030.
5. Amneal. Amneal Launches Generic Butrans® Following ANDA Approval by FDA.