SUBOXONE Drug Patent Profile

Which patents cover Suboxone, and when can generic versions of Suboxone launch?

Suboxone is a drug marketed by Indivior and is included in two NDAs. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and ninety-three patent family members in twenty-six countries.

The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Suboxone

A generic version of SUBOXONE was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22^nd, 2013.

Summary for SUBOXONE

International Patents:	193
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	97
Drug Prices:	Drug price information for SUBOXONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBOXONE
What excipients (inactive ingredients) are in SUBOXONE?	SUBOXONE excipients list
DailyMed Link:	SUBOXONE at DailyMed

See drug prices for SUBOXONE

See drug sales revenues for SUBOXONE

Recent Clinical Trials for SUBOXONE

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

Sponsor	Phase
Bicycle Health	Phase 4
Royal Victoria Hospital, Canada	Phase 4
Indivior Inc.	Phase 1

See all SUBOXONE clinical trials

Pharmacology for SUBOXONE

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

Paragraph IV (Patent) Challenges for SUBOXONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 SUBOXONE

SUBOXONE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	020733-002	Oct 8, 2002		DISCN	Yes	No
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No			Y

Expired US Patents for SUBOXONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010
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
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012

International Patents for SUBOXONE

When does loss-of-exclusivity occur for SUBOXONE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Peru

Russian Federation

Singapore

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SUBOXONE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2004537750
Australia	2006329819	pH modulated films for delivery of actives
Japan	2011068689	THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY AND DRUG DELIVERY SYSTEMS MADE FROM THE SAME
European Patent Office	2332523	Films uniformes pour la forme de dosage de dissolution rapide incorporant des compositions de masquage du goût (Uniform films for rapid dissolve dosage form incorporating taste-masking compositions)
China	1668961	Tunable optical instruments
China	103002885	Film compositions for delivery of actives

SUBOXONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUBOXONE

Introduction

SUBOXONE, a combination of buprenorphine and naloxone, is a crucial medication in the treatment of opioid use disorder (OUD). The market for SUBOXONE is influenced by several key factors, including rising opioid abuse rates, advancements in treatment options, and regulatory changes. Here, we delve into the market dynamics and financial trajectory of SUBOXONE.

Market Size and Growth

The United States SUBOXONE market is projected to grow significantly over the next few years. As of 2024, the market is valued at USD 2.29 billion and is expected to reach USD 3.15 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.1% from 2024 to 2031[1].

Market Drivers

Several factors are driving the growth of the SUBOXONE market:

Rising Opioid Abuse and Addiction Rates

The increasing prevalence of opioid abuse and addiction is a major driver. As more individuals seek treatment, the demand for effective medications like SUBOXONE rises[1].

Growth in Awareness About Drug Treatment

Increased awareness and acceptance of opioid addiction treatment have led to more people seeking medical help, thereby boosting the market for SUBOXONE[1].

Availability of Generic Formulations

The availability of generic formulations of SUBOXONE has made the treatment more accessible and affordable, contributing to market growth[1].

Favorable Reimbursement Policies

Government and insurance reimbursement policies that support the use of SUBOXONE have also played a significant role in driving market expansion[1].

Strong Product Pipeline

The stable and strong pipeline of new and innovative formulations of SUBOXONE is another key driver. Companies are consistently introducing new products to treat opioid addiction more effectively, which helps in maintaining market momentum[1].

Financial Performance of Key Players

Indivior

Indivior, a major player in the SUBOXONE market, has experienced mixed financial results. While the company saw a significant decline in SUBOXONE Film share, it offset this loss with strong growth in SUBLOCADE (buprenorphine extended-release) injection. In FY 2020, SUBLOCADE net revenue grew by 75% to $126 million, despite overall net revenue decreasing by 18% due to various factors including the loss of authorized generics (AGx) program and legal defense costs[3].

Revenue Trends

The U.S. net revenue for Indivior decreased by 23% in FY 2020, primarily due to the loss of SUBOXONE Film market share. However, Q4 2020 saw a 68% increase in U.S. net revenue, driven by strong growth in the Organized Health Systems (OHS) channel[3].

Regional Outlook

United States

The U.S. market remains a significant segment for SUBOXONE. Despite challenges such as the loss of market share for SUBOXONE Film, the overall U.S. opioid use disorder (OUD) market continues to grow, albeit at a low teens percentage rate[3].

Rest of the World

Outside the U.S., the market for SUBOXONE faces different challenges. For instance, in Western European markets, austerity measures have led to a 3% decrease in net revenue for Indivior in FY 2020[3].

Competitive Landscape

The SUBOXONE market is characterized by medium market concentration, with several major players including Dr. Reddy’s Laboratories Ltd., Mylan N.V., Novartis AG, Sun Pharmaceutical Industries Ltd, and Alkem Labs. These companies are actively involved in developing new formulations and expanding their market presence[1].

Regulatory and Legal Impacts

Changes in federal laws and regulations have impacted the SUBOXONE market. For example, the federal law change enacted in October 2019 (HR 4378) modified the impact of authorized generics in determining the mandated rebate amount in government channels, negatively affecting Q4 2019 net revenue for Indivior[3].

Cost-Effectiveness and Treatment Outcomes

Studies have shown that buprenorphine, the active ingredient in SUBOXONE, is effective in reducing opioid use, particularly at higher doses. Interventions that increase buprenorphine treatment duration are considered cost-effective and preferred strategies for improving treatment outcomes[5].

"Interventions that increase buprenorphine treatment duration concurrently with treatment capacity are the most cost-effective," according to a study published in JAMA Health Forum[5].

Market Trends and Opportunities

Increasing Prescription of Opioids

In regions like the U.K., high consumption rates of prescription opioids for pain management are expected to drive the growth of the SUBOXONE market. This trend is also observed in the U.S., where chronic pain affects a significant portion of the population, leading to increased demand for opioid addiction treatments[4].

Chronic Pain Prevalence

The prevalence of chronic pain, especially among older adults, is another factor driving the market. According to the Centers for Disease Control and Prevention, an estimated 20.4% of U.S. adults had chronic pain in 2016, which is expected to continue driving the demand for SUBOXONE[4].

Key Takeaways

• The U.S. SUBOXONE market is projected to grow from USD 2.29 billion in 2024 to USD 3.15 billion by 2031.
• Rising opioid abuse rates, increased awareness of drug treatment, availability of generic formulations, and favorable reimbursement policies are key market drivers.
• The strong product pipeline and innovative formulations are crucial for market growth.
• Indivior’s financial performance has been impacted by market share loss and regulatory changes but is offset by growth in other products like SUBLOCADE.
• The cost-effectiveness of buprenorphine treatment and increasing prescription of opioids for chronic pain are significant market trends.

FAQs

1. What is the projected market size of SUBOXONE in the United States by 2031? The U.S. SUBOXONE market is expected to reach USD 3.15 billion by 2031[1].

2. What are the key drivers of the SUBOXONE market? Key drivers include rising opioid abuse rates, growth in awareness about drug treatment, availability of generic formulations, and favorable reimbursement policies[1].

3. How has Indivior’s financial performance been affected in recent years? Indivior’s financial performance has been impacted by the loss of SUBOXONE Film market share, but it has seen strong growth in SUBLOCADE net revenue[3].

4. What is the impact of chronic pain prevalence on the SUBOXONE market? The prevalence of chronic pain, especially among older adults, drives the demand for opioid addiction treatments, including SUBOXONE[4].

5. Is buprenorphine treatment cost-effective? Yes, interventions that increase buprenorphine treatment duration are considered cost-effective and preferred strategies for improving treatment outcomes[5].

Sources

1. CoherentMI - United States of America Suboxone Market Size
2. RecoveryAnswers - Dosing of Suboxone & Opioid Dependency Treatment Outcomes
3. Indivior - FY 2020 Financial Results Announced
4. GlobeNewswire - Global Suboxone Market Analysis/Forecast Report 2022-2030
5. JAMA Health Forum - Cost-effectiveness of Increasing Buprenorphine Treatment Initiation