Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details

What are the generic drug 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, Ascent Pharms Inc, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Indivior, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Edenbridge Pharms, and is included in twenty-five NDAs. There are seventeen 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 one hundred and seventy-seven patent family members in thirty-six countries.

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

Summary for buprenorphine hydrochloride; naloxone hydrochloride

International Patents:	177
US Patents:	17
Tradenames:	5
Applicants:	19
NDAs:	25
Finished Product Suppliers / Packagers:	26
Clinical Trials:	141
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
Atea Pharmaceuticals, Inc.	PHASE1
University of North Carolina, Chapel Hill	PHASE4
NYU Langone Health	PHASE4

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
Teva Pharms Usa	CASSIPA	buprenorphine hydrochloride; naloxone hydrochloride	FILM;SUBLINGUAL	208042-001	Sep 7, 2018		DISCN	Yes	No
Difgen Pharms	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	212756-003	Feb 13, 2025	AB	RX	No	No
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y
Hikma	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	203326-001	Jun 27, 2014	AB	RX	No	No
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y

Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010

International Patents for buprenorphine hydrochloride; naloxone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Norway	340668
Croatia	P20160405
Japan	5586151
Hong Kong	1193568
Singapore	2014009401	NEW ABUSE-RESISTANT PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF OPIOID DEPENDENCE
European Patent Office	3566692	DISPOSITIFS D'ADMINISTRATION TRANSMUQUEUSE AVEC ABSORPTION ACCRUE (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE)

Buprenorphine hydrochloride; naloxone hydrochloride Market Analysis and Financial Projection

Last updated: February 14, 2026

Market Dynamics for Buprenorphine Hydrochloride/Naloxone Hydrochloride

Market Overview

Buprenorphine hydrochloride combined with naloxone hydrochloride (marketed as Suboxone, Bunavail, Zubsolv) is primarily prescribed for opioid dependence treatment. The combination's unique formulation reduces the potential for misuse compared to buprenorphine alone.

Key Drivers

1. Opioid Crisis: The global rise in opioid addiction has increased demand for effective treatment options. The U.S. opioid overdose death rate reached 49.4 per 100,000 in 2021, with medication-assisted treatment (MAT) recognized as essential [1].

2. Regulatory Support: Agencies such as the FDA and DEA have expanded access to buprenorphine formulations. The introduction of long-acting formulations and relaxed prescribing rules in some regions encourages uptake.

3. Product Approvals and Patent Expirations: Brand-name drugs such as Suboxone face imminent patent expiry, opening market share to generics, which typically drive down costs and increase adoption.

4. Healthcare System Adoption: Integration into outpatient treatment programs and increased insurance coverage expand patient access.

Market Challenges

• Regulatory Barriers: Strict prescribing regulations limit rapid expansion.
• Misuse and Diversion: Despite naloxone inclusion, diversion remains a concern.
• Pricing and Reimbursement: High costs of branded drugs and inconsistent reimbursement policies limit accessibility in certain regions.

Market Size & Growth

• The global opioid dependence treatment market was valued at approximately USD 0.88 billion in 2022.
• Compound annual growth rate (CAGR) from 2023–2028 is projected at 8–10%, driven by increasing prevalence of opioid use disorder (OUD).

Regional Outlook

Region	Market Share (2022)	Growth Drivers	Challenges
North America	70%	High OUD prevalence, regulatory support	Market saturation, generic competition
Europe	15%	Expansion of addiction treatment programs	Regulatory complexities
Asia-Pacific	8%	Growing awareness, expanding healthcare access	Limited infrastructure, regulatory hurdles
Rest of World	7%	Emerging markets, unmet demand	Cost and regulatory challenges

Financial Trajectory

Revenue Streams

• Brand-Name Products: Suboxone (Alkermes, Indivior), Zubsolv (ticker: ALKS), Bunavail.
• Generic Products: Entered the market post-patent expiry, significantly reducing prices.

Historical Revenue Data (USD million)

Year	Brand-Name Revenue	Generic Revenue	Total Revenue
2020	1,200	200	1,400
2021	1,350	400	1,750
2022	1,200	600	1,800

Note: Data reflects USD revenue estimates from leading market participants (e.g., Indivior, Alkermes).

Profitability & Investment

• Research & Development: Increasing R&D budgets for novel formulations, including long-acting injectables and implants.
• Market Entry Costs: High regulatory and manufacturing costs for generics slow down market penetration.
• Pricing Trends: Branded drugs maintain premium prices (~USD 300–400 per 8mg/2mg dose), while generics see prices as low as USD 50 per dose.

Strategic Movements & Market Penetration

• Companies are expanding into emerging markets with generic formulations.
• Mergers and acquisitions focus on acquiring patents or licensing agreements to broaden product portfolios.
• Investment in abuse-deterrent formulations and alternative delivery methods influence future revenue streams.

Future Outlook

• Longer-acting formulations (injectables, implants) will capture growing segments seeking reduced dosing frequency.
• Regulatory changes expanding prescribing rights will potentially quicken market growth.
• Generic sales will outpace branded revenues, especially after patent expirations in major markets.

Key Takeaways

• The opioid dependence treatment market, centered on buprenorphine/naloxone combinations, is expanding due to rising opioid use disorder prevalence.
• Market growth is driven by regulatory easing, product innovation, and increased awareness.
• While branded drugs maintain premium pricing, generic competition is rapidly increasing, pressuring revenues.
• Emerging markets present growth opportunities, though regulatory and infrastructural hurdles persist.
• Investment focus is shifting toward long-acting formulations and abuse-deterrent technologies to sustain market relevance.

FAQs

1. When is the patent for Suboxone set to expire?
The primary patent for Suboxone in the U.S. was set to expire in 2023, with certain formulation patents extending into 2024. Generic versions entered the market post-expiration.

2. What are the key regulatory barriers affecting market growth?
Restrictive prescribing rules through the Drug Addiction Treatment Act (DATA 2000), which limits prescribing to certified physicians, and state-level licensing requirements.

3. How do generics impact the market?
They lower treatment costs, increase access, and shift market share away from branded products, pressuring profit margins.

4. What innovations are expected in the next five years?
Long-acting injectable formulations, implantable devices, and abuse-deterrent designs aim to improve adherence and reduce diversion.

5. Which regions present the most significant growth potential?
Asia-Pacific and Latin America, where opioid use disorder management infrastructure is developing, and regulatory barriers are easing.

Citations

[1] National Institute on Drug Abuse. "Opioid overdose deaths". 2022.