Buprenorphine - Generic Drug Details

What are the generic sources for buprenorphine and what is the scope of freedom to operate?

Buprenorphine is the generic ingredient in fourteen branded drugs marketed by Alvogen, Amneal, Difgen Pharms, Mylan Tech Viatris, Watson Labs Teva, Purdue Pharma Lp, Braeburn, Indivior, Bdsi, Reacx Pharms, Am Regent, Endo Operations, Hikma, Hospira, Somerset Theraps Llc, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty-eight NDAs. There are thirty-eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has one hundred and seventy-five patent family members in thirty-six countries.

There are twenty-nine drug master file entries for buprenorphine. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for buprenorphine

International Patents:	175
US Patents:	38
Tradenames:	14
Applicants:	32
NDAs:	48
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	497
Patent Applications:	4,270
Drug Prices:	Drug price trends for buprenorphine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine
What excipients (inactive ingredients) are in buprenorphine?	buprenorphine excipients list
DailyMed Link:	buprenorphine at DailyMed

See drug prices for buprenorphine

Recent Clinical Trials for buprenorphine

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 1
Icahn School of Medicine at Mount Sinai	Phase 4
Cure Addiction Now	Phase 3

See all buprenorphine clinical trials

Generic filers with tentative approvals for BUPRENORPHINE

Applicant	Application No.	Strength	Dosage Form
		EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
		EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET;SUBLINGUAL
		EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET;SUBLINGUAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for buprenorphine

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for buprenorphine

Analgesics, Opioid

Narcotic Antagonists

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for buprenorphine

N02AE	Oripavine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPRENORPHINE

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 buprenorphine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-001	May 23, 2023		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No			Y

Expired US Patents for buprenorphine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	021306-002	Jun 30, 2010
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023

EU/EMA Drug Approvals for buprenorphine

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 buprenorphine

Country	Patent Number	Title	Estimated Expiration
South Africa	201209233
South Korea	20130135026
Japan	2008542437
Hungary	E038275

Buprenorphine Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The buprenorphine market is poised for significant growth in the coming years. As of 2023, the global buprenorphine market was valued at approximately USD 5.44 billion to USD 5.52 billion, depending on the source[1][3][4].

By 2036, the market is expected to exceed USD 31.27 billion, with a compounded annual growth rate (CAGR) of over 14.4% to 14.9% during the forecast period from 2024 to 2036[1][3][4].

Growth Drivers

Several factors are driving the growth of the buprenorphine market:

Increasing Prevalence of Opioid Use Disorder

The escalating issue of opioid addiction globally is a major driver. According to various studies, a significant percentage of patients prescribed opioids for chronic pain misuse them, leading to opioid use disorder (OUD). For instance, in North America, 21 to 29 percent of patients misuse opioids prescribed for chronic pain, with 8-12% developing an OUD[1].

Regulatory Approvals

Recent approvals by regulatory authorities, such as the U.S. Food and Drug Administration (FDA), for buprenorphine treatments, including the approval of Brixadi (buprenorphine) extended-release injection, are boosting market growth. These approvals expand the treatment options available for moderate to severe OUD[3][4].

Government Investments in Healthcare

Increased government investments in healthcare, particularly in developed nations, are also contributing to the market's expansion. These investments enhance the accessibility and affordability of buprenorphine treatments[1].

Growing Demand for Effective Pain Management

The rising incidence of chronic pain disorders and cancer further drives the demand for buprenorphine. According to the World Health Organization (WHO), cancer is a leading cause of deaths worldwide, accounting for about 10 million deaths in 2020[1].

Market Segmentation

The buprenorphine market is segmented based on several criteria:

Route of Administration

The market is segmented into sublingual, transdermal, and buccal routes of administration. The sublingual segment is expected to hold the largest share due to the increasing availability of buprenorphine drugs in various dosages and the rapid drug absorption, first-pass metabolism, and quick onset of action associated with this route[1].

Geographical Regions

North America is projected to account for the largest revenue share by 2036, driven by the strong presence of market players and the high prevalence of opioid dependency in the region. Europe and the Asia Pacific are also expected to contribute significantly to the market growth due to new medical product launches and growing awareness about buprenorphine's health benefits[1][3].

Cost-Effectiveness and Economic Evaluation

Economic evaluations highlight the cost-effectiveness of buprenorphine treatments:

Transmucosal vs. Extended-Release Buprenorphine

Studies using state transition models have shown that treatment with transmucosal buprenorphine is generally more cost-effective than extended-release buprenorphine. For instance, transmucosal buprenorphine yielded an incremental cost-effectiveness ratio (ICER) of $19,740 per quality-adjusted life year (QALY) compared to no medication treatment, while extended-release buprenorphine was less effective and more costly[2].

Impact of Treatment Duration and Capacity

Interventions that increase buprenorphine treatment duration and expand treatment capacity, such as contingency management and telehealth, are associated with better outcomes and higher cost-effectiveness. These strategies can avert a significant number of opioid overdose deaths and are preferred at various willingness-to-pay thresholds[5].

Challenges and Opportunities

While the market is growing, there are challenges and opportunities to consider:

Challenges

• High costs associated with extended-release formulations can be a barrier.
• Lower retention rates for extended-release buprenorphine compared to transmucosal buprenorphine (29% vs. 47% at 6 months) can impact treatment effectiveness[2].

Opportunities

• The increasing dependency on painkillers and the subsequent rise in opioid addiction present lucrative opportunities for buprenorphine.
• Growing awareness and regulatory approvals are expected to expand the market further[1][3].

Regional Market Analysis

North America

North America is expected to dominate the market due to the high prevalence of opioid dependency and strong market presence. The region saw a significant increase in buprenorphine prescriptions, from 1.9 million to 4.3 million between 2009 and 2018[3].

Europe and Asia Pacific

Europe is anticipated to acquire a notable share due to new medical product launches, while the Asia Pacific region is expected to witness noteworthy growth driven by a rising patient pool and increasing awareness about buprenorphine's benefits[1].

Key Takeaways

• The buprenorphine market is expected to grow significantly, driven by the increasing prevalence of opioid use disorder and chronic pain.
• Regulatory approvals and government investments in healthcare are key drivers.
• The sublingual route of administration is expected to dominate the market.
• North America will lead the market, followed by Europe and the Asia Pacific.
• Cost-effectiveness studies favor transmucosal buprenorphine over extended-release formulations.

FAQs

1. What is the current market size of the buprenorphine market? The global buprenorphine market was valued at approximately USD 5.44 billion to USD 5.52 billion in 2023[1][3][4].

2. What is the projected growth rate of the buprenorphine market? The market is expected to grow at a CAGR of over 14.4% to 14.9% from 2024 to 2036[1][3][4].

3. Which region is expected to dominate the buprenorphine market? North America is expected to account for the largest revenue share by 2036 due to the strong presence of market players and high prevalence of opioid dependency[1][3].

4. What are the main drivers of the buprenorphine market growth? Key drivers include the increasing prevalence of opioid use disorder, regulatory approvals, government investments in healthcare, and growing demand for effective pain management[1][3][4].

5. Which route of administration is expected to hold the largest share in the buprenorphine market? The sublingual route of administration is anticipated to hold the largest share due to its rapid drug absorption and quick onset of action[1].

Citations

1. Research Nester, "Buprenorphine Market Size & Share, Growth Trends 2036"
2. JAMA Network, "Extended-Release Buprenorphine for Persons With Opioid Use Disorder"
3. Coherent Market Insights, "Buprenorphine Market Size, Trends and Forecast to 2030"
4. Coherent Market Insights, "Buprenorphine Market Size and Trends"
5. JAMA Health Forum, "Cost-effectiveness of Increasing Buprenorphine Treatment Initiation"

Last updated: 2024-12-16