BUNAVAIL Drug Patent Profile

When do Bunavail patents expire, and what generic alternatives are available?

Bunavail is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-three patent family members in twenty-six countries.

The generic ingredient in BUNAVAIL 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 Bunavail

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

Summary for BUNAVAIL

International Patents:	83
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	279
Drug Prices:	Drug price information for BUNAVAIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUNAVAIL
What excipients (inactive ingredients) are in BUNAVAIL?	BUNAVAIL excipients list
DailyMed Link:	BUNAVAIL at DailyMed

See drug prices for BUNAVAIL

Recent Clinical Trials for BUNAVAIL

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

Sponsor	Phase
Indivior Inc.	Phase 4
BioDelivery Sciences International	Phase 3

See all BUNAVAIL clinical trials

Paragraph IV (Patent) Challenges for BUNAVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	6.3 mg/1 mg	205637	1	2015-12-21

US Patents and Regulatory Information for BUNAVAIL

BUNAVAIL 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
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No	9,655,843		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No	9,522,188		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No	8,703,177		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014		DISCN	Yes	No	9,522,188		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No	8,703,177		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No	8,147,866		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No	9,522,188		Y

Expired US Patents for BUNAVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	7,579,019
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	6,159,498
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	6,159,498
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014	6,159,498
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	7,579,019
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014	7,579,019

International Patents for BUNAVAIL

When does loss-of-exclusivity occur for BUNAVAIL?

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

Australia

Brazil

Canada

China

European Patent Office

Japan

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 BUNAVAIL around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	96455	СРЕДСТВА ДЛЯ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА, КОТОРЫЕ ОБЕСПЕЧИВАЮТ ИХ УСИЛЕННОЕ УСВОЕНИЕ;ЗАСОБИ ДЛЯ ТРАНСМУКОЗАЛЬНОЇ ДОСТАВКИ ЛІКІВ, ЯКІ ЗАБЕЗПЕЧУЮТЬ ЇХ ПОСИЛЕНЕ ЗАСВОЄННЯ (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE)
Germany	69923675
China	103889508	Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Japan	2009544619
Eurasian Patent Organization	201991223	НЕ ВЫЗЫВАЮЩИЕ ЗАВИСИМОСТЬ МУКОАДГЕЗИВНЫЕ УСТРОЙСТВА ДЛЯ ДОСТАВКИ БУПРЕНОРФИНА
Israel	196529	בופרנורפין לשימוש בהכנת תכשיר רוקחי להגרת הספיגה מחדש של בופרנורפין וכהתקן לשחרור תרופה מתכלה מוקואדהסיבי (Buprenorphine for use in the preparation of a pharmaceutical composition for providing enhanced uptake of buprenorphine and mucoadhesive bioerodable drug delivery device based thereon)
Norway	20090278

BUNAVAIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BUNAVAIL

Introduction

BUNAVAIL, a buccal film formulation of buprenorphine and naloxone, was introduced by BioDelivery Sciences International, Inc. (BDSI) as a treatment for opioid dependence. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Context

The opioid use disorder (OUD) market has been growing steadily, driven by increasing cases of opioid addiction and strong demand for effective therapeutics. The global OUD market is projected to grow from $3.62 billion in 2024 to $7.48 billion by 2032, with the buprenorphine segment expected to lead this growth[4].

Product Launch and Initial Reception

BUNAVAIL was launched in November 2014, marking a significant milestone for BDSI as it transitioned into a commercial entity. The drug was designed using BDSI's patented BioErodible MucoAdhesive (BEMA) technology, which allows for efficient and convenient delivery of buprenorphine, potentially overcoming administration challenges of sublingual dosage forms[1].

Competitive Landscape

BUNAVAIL entered the market as a direct competitor to Suboxone sublingual film, which had seen significant sales of over $1.3 billion in the U.S. in 2013. The introduction of BUNAVAIL aimed to provide an alternative treatment option for the over 2.5 million people dependent on opioids[1].

Commercialization and Distribution

At launch, BUNAVAIL was supported by an experienced field sales team and Medical Science Liaisons (MSLs). BDSI also partnered with Ashfield Market Access to maximize patient access through managed markets and trade support. Initially, it was anticipated that BUNAVAIL would be available to approximately 165-175 million covered commercial lives[1].

Financial Performance

Initial Years

In the initial years following its launch, BUNAVAIL showed modest sales. For full-year 2018, BUNAVAIL net sales were $5.4 million. However, this figure declined significantly in subsequent years. By full-year 2019, BUNAVAIL net sales had dropped to $2.3 million, a reduction of 57.4% compared to the previous year[2][5].

Decline and Discontinuation

The financial performance of BUNAVAIL continued to deteriorate, leading to a significant decline in sales. In the fourth quarter of 2019, BUNAVAIL net sales were ($0.5) million, reflecting a 141.7% reduction compared to the same period in 2018. This decline was partly due to the announcement in March 2020 of the discontinuation of BUNAVAIL's marketing, which resulted in one-time additional revenue reserves and non-recurring financial impacts[2][5].

Reasons for Decline

Several factors contributed to the decline of BUNAVAIL:

• Market Competition: The OUD market is highly competitive, with established brands like Suboxone and newer entrants like SUBLOCADE. BUNAVAIL struggled to gain significant market share against these competitors[3].
• Administrative Challenges: Despite its innovative delivery mechanism, BUNAVAIL may not have fully addressed the administration challenges as effectively as anticipated, leading to lower adoption rates.
• Regulatory and Market Dynamics: Changes in regulatory environments and market dynamics, including the impact of the COVID-19 pandemic, may have affected the drug's commercial viability[3].

Discontinuation of Marketing

In March 2020, BDSI announced the discontinuation of BUNAVAIL's marketing, citing financial and market-related reasons. This decision was reflected in the company's financial reports, which included non-recurring financial impacts related to this discontinuation[2][5].

Conclusion

BUNAVAIL's market dynamics and financial trajectory were marked by initial hopes of providing a novel treatment option for opioid dependence but ultimately ended in decline and discontinuation. The competitive landscape, administrative challenges, and broader market dynamics all played roles in its commercial failure.

Key Takeaways

• BUNAVAIL was introduced as a buccal film formulation of buprenorphine and naloxone to treat opioid dependence.
• Despite initial hopes, the drug failed to gain significant market share due to strong competition and other market factors.
• Financial performance declined significantly, leading to the discontinuation of its marketing in 2020.
• The OUD market continues to grow, but successful products must navigate intense competition and evolving regulatory environments.

FAQs

What is BUNAVAIL?

BUNAVAIL is a buccal film formulation of buprenorphine and naloxone, designed for the maintenance treatment of opioid dependence.

Why was BUNAVAIL introduced?

BUNAVAIL was introduced to provide an alternative treatment option for opioid dependence, leveraging BDSI's patented BEMA technology for efficient drug delivery.

What were the initial sales figures for BUNAVAIL?

In full-year 2018, BUNAVAIL net sales were $5.4 million, but these figures declined significantly in subsequent years.

Why did BUNAVAIL's sales decline?

BUNAVAIL's sales declined due to strong competition from established brands, administrative challenges, and broader market dynamics.

What led to the discontinuation of BUNAVAIL's marketing?

The discontinuation was due to financial and market-related reasons, including the drug's failure to gain significant market share and the associated non-recurring financial impacts.

What is the current state of the OUD market?

The global OUD market is projected to grow significantly, driven by increasing cases of opioid addiction and strong demand for effective therapeutics.

Sources

1. BioDelivery Sciences Announces the Availability of BUNAVAIL™ in the US - PR Newswire
2. BioDelivery Sciences Reports Strong Fourth Quarter and Full-Year 2019 Results - BioSpace
3. FY 2020 Financial Results Announced - Indivior
4. Opioid Use Disorder [OUD] Market Size, Share | Growth, 2032 - Fortune Business Insights
5. BioDelivery Sciences Reports Strong Fourth Quarter and Full-Year 2019 Results - GlobeNewswire