BUPRENORPHINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for buprenorphine hydrochloride and what is the scope of patent protection?

Buprenorphine hydrochloride is the generic ingredient in ten branded drugs marketed by Bdsi, Alvogen, Reacx Pharms, Indivior, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Difgen Pharms, 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 NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has ninety-two patent family members in twenty-eight countries.

There are sixteen drug master file entries for buprenorphine hydrochloride. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BUPRENORPHINE HYDROCHLORIDE

International Patents:	92
US Patents:	20
Tradenames:	10
Applicants:	26
NDAs:	40
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	497
Patent Applications:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPRENORPHINE HYDROCHLORIDE
What excipients (inactive ingredients) are in BUPRENORPHINE HYDROCHLORIDE?	BUPRENORPHINE HYDROCHLORIDE excipients list
DailyMed Link:	BUPRENORPHINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE

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 HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
		EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET;SUBLINGUAL
		EQ 11.4MG BASE;EQ 2.9MG 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

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BUPRENORPHINE HYDROCHLORIDE

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 HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELBUCA	Buccal Film	buprenorphine hydrochloride	75 mcg and 150 mcg	207932	1	2016-10-24
BELBUCA	Buccal Film	buprenorphine hydrochloride	300 mcg, 450 mcg, 600 mcg and 750 mcg	207932	1	2016-10-04
BELBUCA	Buccal Film	buprenorphine hydrochloride	900 mcg	207932	1	2016-09-12

US Patents and Regulatory Information for BUPRENORPHINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No	10,946,010		Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes	9,439,900		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015		RX	Yes	No	9,901,539
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	11,020,388		Y
Dr Reddys Labs Sa	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	206953-001	Jul 17, 2020		DISCN	No	No
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes	8,475,832		Y

Expired US Patents for BUPRENORPHINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015	7,579,019
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015	6,159,498

International Patents for BUPRENORPHINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2005528422
China	110123792	用于慢性疼痛缓解的跨粘膜药物传递装置 (Transmucosal drug delivery devices for use in chronic pain relief)
Slovenia	2054031
Poland	2054031
Russian Federation	2019118034	СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА, СРЕДСТВО ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ
Singapore	11201403075X	TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF

BUPRENORPHINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Buprenorphine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

Buprenorphine hydrochloride, a medication used to treat opioid dependence and manage chronic pain, is experiencing significant growth in the global market. Here’s a detailed look at the market dynamics and financial trajectory of this crucial drug.

Market Size and Growth

The global buprenorphine market is projected to undergo substantial growth over the coming years. As of 2023, the market size was valued at USD 5.44 billion and is expected to exceed USD 31.27 billion by 2036, registering a Compound Annual Growth Rate (CAGR) of over 14.4% during the forecast period[1].

Another estimate suggests that the global buprenorphine market will grow at a CAGR of 8.2% from 2023 to 2028, reaching USD 9.9 billion by 2028[3].

Growth Drivers

Several factors are driving the growth of the buprenorphine market:

Increasing Prevalence of Opioid Dependence

The rising incidence of opioid use disorder (OUD) is a major driver. According to the CDC, over 131,778,501 opioid prescriptions were dispensed in the U.S. in 2022, and about 145,000 patients were newly diagnosed with OUD[4].

Chronic Pain Management

Buprenorphine is also used for managing acute and chronic pain, which is becoming more prevalent, especially among the growing elderly population. Conditions like osteoarthritis and rheumatoid arthritis contribute significantly to this demand[3].

Government Initiatives

Government initiatives aimed at addressing substance dependency and drug abuse are boosting market growth. For example, collaborative anti-drug efforts in various countries are increasing awareness and access to buprenorphine treatment[3].

Technological Advancements

The development of new formulations, such as long-acting injectable medicines, is expanding the market. Indivior PLC's acquisition of rights to develop and market long-acting injectable buprenorphine formulations is a notable example[4].

Route of Administration

The market is segmented by the route of administration, with the sublingual segment anticipated to hold the largest share. This is due to the increasing availability of buprenorphine in sublingual forms, rapid drug absorption, and quick onset of action[1].

• Sublingual: Dominates the market due to its efficacy and convenience.
• Buccal: Expected to witness notable growth as more patients opt for oral drugs over injection-based treatments.
• Transdermal: Commonly used for chronic pain management, particularly through patches[1][3].

Geographical Analysis

North America

North America is set to account for the largest revenue share by 2036, driven by the strong presence of market players and a high percentage of the population suffering from opioid dependency. The region also sees a high number of cases related to drug abuse, such as heroin and cocaine[1].

Europe

Europe is expected to acquire a significant share due to new medical product launches and healthcare reforms. The market in Europe is influenced by research advancements and patient-focused initiatives[1][4].

Asia Pacific

The Asia Pacific region is projected to witness noteworthy growth due to a rising patient pool and increasing awareness about the health benefits of buprenorphine[1].

Market Restraints

Despite the growth, several challenges hinder the market:

Side Effects

Side effects associated with buprenorphine use can restrain market growth. Common side effects include nausea, dizziness, and constipation[3].

Lack of Licensed Physicians

A lack of licensed physicians approved to prescribe buprenorphine can also hinder market growth. According to a study, less than 4% of licensed physicians are approved to prescribe buprenorphine for opioid use disorder[3].

Financial Performance and Projections

Revenue Projections

The buprenorphine market is expected to grow significantly, with revenues projected to exceed USD 31.27 billion by 2036 from USD 5.44 billion in 2023[1].

Company Performance

Companies like Indivior PLC have seen fluctuations in their financial performance due to factors such as generic competition. For instance, Indivior's net revenue from SUBOXONE® Film was adversely impacted by the introduction of generic buprenorphine/naloxone film alternatives, but this was partially offset by growth in other products like SUBLOCADE®[2].

Key Players and Strategies

Key players in the market are focusing on expanding their product offerings and geographical reach. Indivior PLC's acquisition of exclusive global rights to develop and market long-acting injectable buprenorphine formulations is a strategic move to enhance market presence[4].

Innovations and Investments

Investments in promotion, channel development, and treatment advocacy, including direct-to-consumer advertising, are also driving market growth. For example, Indivior launched a U.S. DTC advertising campaign to increase patient and healthcare professional awareness of BMAT and SUBLOCADE®[2].

Distribution Channels

The hospital pharmacies segment dominates the market in terms of distribution channels. Hospitals serve as central hubs for patient care, and the increasing preference for hospitals as screening venues contributes to this dominance[3].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the buprenorphine market. While it has highlighted the need for effective addiction treatment, it has also disrupted supply chains and affected healthcare services. However, the long-term growth trajectory remains positive due to the underlying demand for opioid dependence treatment[5].

Key Takeaways

• The buprenorphine market is expected to grow significantly, driven by increasing opioid dependence, chronic pain management, and government initiatives.
• The sublingual route of administration dominates the market due to its efficacy and convenience.
• North America is set to account for the largest revenue share, followed by Europe and Asia Pacific.
• Side effects and a lack of licensed physicians are major restraints.
• Key players are investing in new formulations and marketing strategies to expand their market presence.

Frequently Asked Questions (FAQs)

1. What is the primary use of buprenorphine hydrochloride?

Buprenorphine hydrochloride is primarily used to treat opioid dependence and manage chronic pain.

2. What is the projected market size of buprenorphine by 2036?

The buprenorphine market is expected to exceed USD 31.27 billion by 2036[1].

3. Which region is expected to dominate the buprenorphine market?

North America is set to account for the largest revenue share in the buprenorphine market by 2036[1].

4. What are the major restraints in the buprenorphine market?

Major restraints include side effects associated with buprenorphine use and a lack of licensed physicians approved to prescribe the medication[3].

5. How is the COVID-19 pandemic impacting the buprenorphine market?

The COVID-19 pandemic has had a mixed impact, disrupting supply chains but also highlighting the need for effective addiction treatment, which supports long-term growth[5].

Cited Sources:

1. Research Nester: Buprenorphine Market Size & Share, Growth Trends 2036.
2. Indivior: FY 2019 Adjusted Financial Results In-Line with Guidance.
3. Market Data Forecast: Buprenorphine Market Worth USD 9.9 Bn By 2028.
4. Grand View Research: Naltrexone And Buprenorphine Market Size Report, 2030.
5. Vantage Market Research: Buprenorphine Hydrochloride Market: Trends & Size 2032.