BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - Generic Drug Details

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

Buprenorphine hydrochloride; naloxone hydrochloride is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Indivior, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Orexo Us Inc, and is included in twenty-three NDAs. There are eighteen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride; naloxone hydrochloride has three hundred and thirty-six patent family members in thirty-seven countries.

Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

International Patents:	336
US Patents:	18
Tradenames:	5
Applicants:	18
NDAs:	23
Finished Product Suppliers / Packagers:	24
Clinical Trials:	134
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
DailyMed Link:	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

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

Sponsor	Phase
Johns Hopkins University	Phase 3
Cure Addiction Now	Phase 3
Bicycle Health	Phase 4

See all BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
		EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL
		EQ 2.9MG BASE;EQ 0.71MG 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 HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Drug Class	Opioid Antagonist Partial Opioid Agonist
Mechanism of Action	Opioid Antagonists Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	0.7 mg/0.18 mg	204242	1	2017-05-04
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	2.1 mg/0.3 mg and 4.2 mg/0.7 mg	205637	1	2016-11-23
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	2.9 mg/7.1 mg	204242	1	2015-12-21
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	6.3 mg/1 mg	205637	1	2015-12-21
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	8.6 mg/2.1 mg and 11.4 mg/2.9 mg	204242	1	2015-07-24
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	1.4 mg/0.36 mg and 5.7 mg/1.4 mg	204242	1	2013-10-22
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	12 mg/3 mg	022410	1	2013-05-14
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	2 mg/0.5 mg* and 8 mg/2 mg	022410	1	2012-10-15
SUBOXONE	for Injection	buprenorphine hydrochloride; naloxone hydrochloride	500 mg/vial	020733	2	2009-01-26

US Patents and Regulatory Information for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	205954-003	Jan 24, 2019	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	10,946,010		Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	8,940,330		Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No	8,470,361		Y
Teva Pharms Usa	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	091149-002	Sep 8, 2014		DISCN	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	10,874,661		Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	020733-002	Oct 8, 2002		DISCN	Yes	No

Expired US Patents for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	10,285,910
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	8,017,150
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	7,579,019
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014	8,454,996
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	6,159,498
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	8,603,514
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	10,285,910

International Patents for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2660116
European Patent Office	2079457	PROCÉDÉ DESTINÉ À ADMINISTRER UN PRODUIT EN FILM CONTENANT UN MÉDICAMENT (A METHOD OF ADMINISTERING A FILM PRODUCT CONTAINING A DRUG)
Ireland	20030269	Method for testing uniformity in a film manufacturing process
Hong Kong	1198958	用於傳遞丁丙諾啡的防濫用性粘膜劑裝置 (ABUSE-RESISTANT MUCOADHESIVE DEVICES FOR DELIVERY OF BUPRENORPHINE)
Japan	5484062
Singapore	11201401446R	ABUSE-RESISTANT MUCOADHESIVE DEVICES FOR DELIVERY OF BUPRENORPHINE
Denmark	1463491

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Buprenorphine Hydrochloride and Naloxone Hydrochloride

Introduction

The market for buprenorphine hydrochloride and naloxone hydrochloride is driven by several key factors, including the increasing prevalence of opioid use disorders, the need for effective and affordable treatment options, and supportive government initiatives. Here, we delve into the market dynamics, financial trajectory, and other critical aspects of this market.

Market Size and Growth

The buprenorphine and naloxone market is projected to grow significantly over the forecast period. By 2024, the market size is expected to reach USD 4.73 billion, with a Compound Annual Growth Rate (CAGR) of 4.23% to reach USD 5.82 billion by 2029[1].

Key Drivers of Market Growth

Several factors are driving the growth of this market:

Increasing Prevalence of Opioid Use Disorders

The global increase in opioid addiction and dependence is a significant driver. For instance, over 16 million people worldwide and more than 2.1 million people in the United States are affected by opioid use disorders each year[1].

Advantages of Buprenorphine and Naloxone

The combination of buprenorphine and naloxone offers several advantages, including reduced cravings and withdrawal symptoms, making it an effective treatment for opioid use disorder. Naloxone, in particular, helps decrease the likelihood of diversion and misuse of the combination drug product[3].

Government Initiatives

Government initiatives to manage opioid dependence are also boosting market growth. For example, the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed to expand access to treatment for opioid use disorder (OUD) in the United States, including the use of telehealth in initiating buprenorphine at opioid treatment programs (OTPs)[1].

Regional Market Analysis

North America

North America holds a significant share in the global buprenorphine and naloxone market due to the high prevalence of substance use disorders and acute and chronic pain disorders. The region is also home to several prominent players in the market. Government initiatives and the growing need for effective pain management, particularly postoperative pain, further drive market growth in this region[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market during the forecast period. This growth is attributed to increasing awareness about opioid use disorders, expanding healthcare infrastructure, and growing investment in healthcare services[1].

Market Segments

Generics Segment

The generics segment is projected to show significant growth due to factors such as cost-effectiveness, patent expirations, and the increasing need for affordable treatment options. Generic buprenorphine and naloxone products offer similar efficacy at lower prices, making them more accessible to patients and healthcare systems[1].

Route of Administration

The market is segmented by route of administration, including oral and parenteral routes. Oral transmucosal buprenorphine and naloxone drugs are particularly popular for effective pain management and treating opioid use disorder[4].

Financial Trajectory

Buprenorphine Hydrochloride Market

The global buprenorphine hydrochloride market was valued at USD 135.67 million in 2022 and is expected to reach USD 178.09 million by 2028, exhibiting a CAGR of 4.64% during this period. The market is driven by reduced cravings and withdrawal symptoms and government support and regulations[5].

Buprenorphine and Naloxone Combination Market

As mentioned earlier, the buprenorphine and naloxone combination market is expected to reach USD 4.73 billion in 2024 and grow to USD 5.82 billion by 2029, with a CAGR of 4.23% during the forecast period[1].

Key Players

Major companies operating in the buprenorphine and naloxone market include Indivior PLC, Viatris Inc. (Mylan Inc.), Sandoz AG, Dr. Reddy's Laboratories Ltd., and Hikma Pharmaceuticals PLC. These companies are working towards increasing the production of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets to meet the growing demand for opioid addiction treatment[1].

Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of buprenorphine and naloxone formulations. For example, a randomized clinical trial compared weekly and monthly subcutaneous buprenorphine depot formulations with daily sublingual buprenorphine and naloxone, showing that the depot formulations were noninferior in terms of the proportion of urine samples negative for illicit opioids and response rates among treatment-seeking adults with moderate-to-severe opioid use disorder[2].

Role of Naloxone

Naloxone is added to buprenorphine to decrease the likelihood of diversion and misuse. When taken as directed, the sublingual absorption of naloxone does not interfere with the pharmacologic actions of buprenorphine. However, if the sublingual tablets are crushed and injected, the naloxone effect dominates, bringing on opioid withdrawals and discouraging misuse[3].

Market Attractiveness Analysis

The market attractiveness analysis by region, drug type, route of administration, and distribution channel indicates that North America remains a highly attractive market due to its large patient base and supportive government policies. The Asia Pacific region is also gaining traction due to its growing healthcare infrastructure and increasing awareness about opioid use disorders[4].

Government and Regulatory Support

Government initiatives play a crucial role in the growth of this market. For instance, the proposed rule change by SAMHSA to expand access to treatment for OUD through telehealth is expected to increase the usage of buprenorphine and naloxone combinations[1].

Conclusion

The market for buprenorphine hydrochloride and naloxone hydrochloride is poised for significant growth driven by increasing opioid use disorders, the need for effective and affordable treatments, and supportive government initiatives. The generics segment, particularly, is expected to grow substantially due to its cost-effectiveness and the expiration of patents on branded medications.

Key Takeaways

• The buprenorphine and naloxone market is expected to reach USD 4.73 billion in 2024 and grow to USD 5.82 billion by 2029.
• The generics segment is projected to show significant growth due to cost-effectiveness and patent expirations.
• North America holds a significant share in the global market, while the Asia Pacific region is the fastest-growing.
• Government initiatives and increasing awareness about opioid use disorders are key drivers of market growth.
• The addition of naloxone to buprenorphine helps reduce the likelihood of diversion and misuse.

FAQs

Q: What is the expected market size of the buprenorphine and naloxone market by 2029?

A: The buprenorphine and naloxone market is expected to reach USD 5.82 billion by 2029[1].

Q: Which region is the fastest-growing in the buprenorphine and naloxone market?

A: The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period[1].

Q: Why is naloxone added to buprenorphine?

A: Naloxone is added to buprenorphine to decrease the likelihood of diversion and misuse of the combination drug product[3].

Q: What is the CAGR of the buprenorphine hydrochloride market from 2022 to 2028?

A: The buprenorphine hydrochloride market is expected to exhibit a CAGR of 4.64% from 2022 to 2028[5].

Q: Which companies are major players in the buprenorphine and naloxone market?

A: Major companies include Indivior PLC, Viatris Inc. (Mylan Inc.), Sandoz AG, Dr. Reddy's Laboratories Ltd., and Hikma Pharmaceuticals PLC[1].

Sources

1. Mordor Intelligence: Buprenorphine And Naloxone Market Size & Share Analysis.
2. JAMA Internal Medicine: Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder.
3. Frontiers in Psychiatry: Reconsidering the Usefulness of Adding Naloxone to Buprenorphine.
4. Transparency Market Research: Opioid Use Disorders Market Size, Trends, Outlook 2034.
5. Business Research Insights: Buprenorphine Hydrochloride Market Size, Share, Forecast 2031.