SUBLOCADE Drug Patent Profile

Which patents cover Sublocade, and what generic alternatives are available?

Sublocade is a drug marketed by Indivior and is included in one NDA. There are twelve patents protecting this drug.

This drug has fifty-nine patent family members in thirty-one countries.

The generic ingredient in SUBLOCADE 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 Sublocade

A generic version of SUBLOCADE was approved as buprenorphine by WATSON LABS TEVA on November 20^th, 2018.

Summary for SUBLOCADE

International Patents:	59
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	15
Patent Applications:	3,976
Drug Prices:	Drug price information for SUBLOCADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBLOCADE
What excipients (inactive ingredients) are in SUBLOCADE?	SUBLOCADE excipients list
DailyMed Link:	SUBLOCADE at DailyMed

See drug prices for SUBLOCADE

Recent Clinical Trials for SUBLOCADE

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

Sponsor	Phase
Royal Victoria Hospital, Canada	Phase 4
National Institute on Drug Abuse (NIDA)	Phase 4
Wake Forest University Health Sciences	Phase 2

See all SUBLOCADE clinical trials

Pharmacology for SUBLOCADE

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

US Patents and Regulatory Information for SUBLOCADE

SUBLOCADE is protected by twenty-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	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,498,432		Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	11,000,520
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	8,975,270		Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,272,044
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	9,827,241		Y

EU/EMA Drug Approvals for SUBLOCADE

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 SUBLOCADE

When does loss-of-exclusivity occur for SUBLOCADE?

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

United Kingdom

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 SUBLOCADE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3360538	COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Canada	2801676	COMPOSITIONS (COMPOSITIONS)
United Kingdom	201009549
European Patent Office	2579874	COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Poland	2579874

SUBLOCADE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUBLOCADE

Introduction to SUBLOCADE

SUBLOCADE, developed by Indivior, is a groundbreaking medication in the fight against opioid use disorder (OUD). It is the first long-acting buprenorphine injection approved for the treatment of moderate to severe OUD. Here, we delve into the market dynamics and financial trajectory of SUBLOCADE, highlighting its impact, competitive landscape, and financial performance.

Market Need and Context

The opioid crisis in the U.S. and globally has created a significant demand for effective treatments. According to the National Survey on Drug Use and Health (NSDUH), in 2016, over 11.5 million Americans misused prescription opioids, and more than 2 million were addicted to prescription or illicit opioids[1].

Competitive Landscape

SUBLOCADE enters a market dominated by other buprenorphine-based treatments such as Suboxone, Zubsolv, and Bunavail. However, it offers a unique advantage by being an injectable, once-monthly medication, enhancing compliance and reducing the risk of abuse and diversion.

• Suboxone: The current market leader, Suboxone, has seen declining sales due to generic competition and direct competitors. Its peak sales were $1.082 billion in 2013, but sales are forecasted to decline to $232 million by 2021[1].
• Zubsolv and Bunavail: These are newer daily oral buprenorphine formulations with improved bioavailability compared to Suboxone. However, they do not offer the same level of convenience and compliance as SUBLOCADE[1].
• Vivitrol: Another competitor, Vivitrol, requires detoxification before treatment, a significant drawback compared to SUBLOCADE, which does not require detoxification[1].

Clinical Efficacy and Safety

SUBLOCADE has demonstrated significant clinical efficacy. It achieves complete blockade of drug-liking effects for a full month in most patients and shows higher abstinence rates compared to placebo. In a phase III trial, SUBLOCADE outperformed placebo in opioid presence in urine samples and self-reported opioid use, with more patients completing the six-month study[1].

Market Performance and Growth

SUBLOCADE has shown robust growth since its approval.

• Revenue Growth: In FY 2023, SUBLOCADE's net revenue increased by 54% to $630 million, with Q4 2023 revenue reaching $176 million, a 49% increase from Q4 2022. This growth is attributed to increased penetration in organized health systems and new patient enrollments in the U.S.[2][5].
• Patient Numbers: By Q2 2022, the number of SUBLOCADE patients on a 12-month rolling basis was approximately 65,000, a 76% increase from Q2 2021[3].
• Dispenses: In the third quarter of 2023, dispenses of SUBLOCADE in the U.S. reached around 133,600 units, a 59% increase from the same period in 2022[5].

Financial Trajectory

Indivior's financial performance has been significantly influenced by SUBLOCADE's success.

• Net Revenue: The company's total net revenue for FY 2023 was $800 million, up 21% year-on-year, driven largely by SUBLOCADE's strong performance[5].
• Adjusted Net Income: Despite an operating loss due to litigation and acquisition costs, Indivior's adjusted net income for FY 2023 increased by 32% to $223 million[2].
• Cash and Investments: As of the end of FY 2023, Indivior's cash and investments stood at $451 million, down from $991 million in FY 2022 due to litigation settlements and the Opiant acquisition[2].

Future Outlook

The market for OUD treatments is expected to grow significantly, driven by rising rates of substance use disorders and increased government efforts.

• Market Size: The global opioid use disorder market is projected to grow at a CAGR of 11.65% from 2024 to 2030, reaching a size of over $4.59 billion in 2023[4].
• SUBLOCADE Projections: Sales of SUBLOCADE are forecast to reach blockbuster status, with projections exceeding $1 billion by 2022 and surpassing Suboxone's peak sales[1].

Challenges and Opportunities

While SUBLOCADE has shown impressive growth, there are challenges and opportunities ahead.

• Competition: New entries like Braeburn’s CAM-2038, another subcutaneous buprenorphine formulation, could pose competition. However, SUBLOCADE’s established market presence and clinical efficacy are significant advantages[1].
• Regulatory and Legal: Indivior has faced legal challenges, including antitrust multidistrict litigation, which has been settled, providing more certainty for stakeholders[5].

Key Takeaways

• Clinical Efficacy: SUBLOCADE has demonstrated high abstinence rates and improved compliance compared to daily oral medications.
• Market Growth: Strong revenue growth driven by increased penetration in organized health systems and new patient enrollments.
• Financial Performance: Significant contribution to Indivior's net revenue and adjusted net income.
• Future Outlook: Projected to continue growing, driven by the expanding OUD treatment market.
• Challenges: Competition from new treatments and legal challenges, though these are being managed effectively.

FAQs

Q: What is SUBLOCADE, and how does it differ from other OUD treatments? A: SUBLOCADE is a long-acting buprenorphine injection for the treatment of moderate to severe opioid use disorder. It differs by being an injectable, once-monthly medication, enhancing compliance and reducing abuse and diversion risks.

Q: How has SUBLOCADE performed in clinical trials? A: SUBLOCADE has shown significantly higher abstinence rates compared to placebo and outperformed placebo in opioid presence in urine samples and self-reported opioid use.

Q: What are the financial projections for SUBLOCADE? A: Sales of SUBLOCADE are forecast to reach blockbuster status, exceeding $1 billion by 2022 and surpassing Suboxone's peak sales.

Q: What are the main challenges facing SUBLOCADE in the market? A: New competitors like CAM-2038 and ongoing legal challenges, although the latter have been largely resolved.

Q: How does SUBLOCADE fit into the broader OUD treatment market? A: SUBLOCADE is part of a growing market driven by rising rates of substance use disorders and increased government efforts to address the opioid crisis.

Sources

1. Clarivate Analytics, "Sublocade approval likely to be a game changer in the U.S. fight against opioid addiction," January 17, 2018.
2. Indivior, "FY 2023 Financial Results - Final," February 22, 2024.
3. Indivior, "Q2H1 2022 Results Press Release - FINAL," July 28, 2022.
4. Grand View Research, "Opioid Use Disorder Market Size And Share Report, 2030."
5. Sharecast, "Indivior swings to loss despite strong Sublocade performance," November 9, 2023.