PROBUPHINE Drug Patent Profile

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

Probuphine is a drug marketed by Reacx Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has sixteen patent family members in thirteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Probuphine

A generic version of PROBUPHINE was approved as buprenorphine hydrochloride by HOSPIRA on June 3^rd, 1996.

Summary for PROBUPHINE

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	8
Patent Applications:	5,043
Drug Prices:	Drug price information for PROBUPHINE
What excipients (inactive ingredients) are in PROBUPHINE?	PROBUPHINE excipients list
DailyMed Link:	PROBUPHINE at DailyMed

See drug prices for PROBUPHINE

Recent Clinical Trials for PROBUPHINE

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
Braeburn Pharmaceuticals	Phase 3
National Institute on Drug Abuse (NIDA)	Phase 3

See all PROBUPHINE clinical trials

US Patents and Regulatory Information for PROBUPHINE

PROBUPHINE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016		DISCN	Yes	No	7,736,665

Expired US Patents for PROBUPHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016	7,736,665

International Patents for PROBUPHINE

See the table below for patents covering PROBUPHINE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2005528422
Hungary	E039377
World Intellectual Property Organization (WIPO)	03101358

PROBUPHINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Probuphine

Introduction to Probuphine

Probuphine is a groundbreaking treatment for opioid use disorder (OUD), developed by Titan Pharmaceuticals. It is the first and only subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment. This innovative product utilizes Titan's proprietary ProNeura™ drug delivery system, which consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and buprenorphine[2].

Market Context and Growth Drivers

The global market for opioid use disorder treatments is experiencing significant growth, driven by several key factors:

• Increasing Prevalence of OUD: The rising number of individuals affected by opioid use disorders is a major driver for the market. According to recent studies, the prevalence of substance use disorders, including OUD, is increasing globally, creating a greater demand for effective treatments[3].
• Government Initiatives: Expanding government initiatives to combat the opioid crisis are also propelling market growth. These initiatives include increased funding for treatment programs and favorable reimbursement policies, which enhance patient access to these medications[3].
• Innovations in Treatment: Advances in treatment options, such as long-acting buprenorphine products like Probuphine, are transforming the landscape of addiction medicine. These innovations aim to enhance treatment outcomes and efficiency in managing OUD[3].

Probuphine's Market Position

Unique Selling Proposition

Probuphine stands out due to its unique delivery mechanism. It provides continuous, around-the-clock blood levels of buprenorphine for six months, which can significantly improve adherence and reduce the risk of relapse. This long-acting formulation is particularly beneficial for patients who may struggle with daily medication regimens[2].

Regulatory Approval

Probuphine received FDA approval in May 2016, marking a significant milestone in the treatment of opioid dependence. This approval has been crucial in establishing the product's credibility and market presence[2].

Financial Trajectory

Historical Performance

The commercialization of Probuphine was initially handled by Braeburn under a license agreement signed in December 2012. However, in May 2018, Titan Pharmaceuticals and Braeburn mutually terminated this agreement, with Titan regaining all rights to the commercialization and clinical development of Probuphine in the U.S. and Canada. This transition allowed Titan to reassess and refocus its market strategy for the product[2].

Current Market Dynamics

Despite initial challenges, including a decline in sales due to COVID-19-related disruptions, the market for OUD treatments is poised for growth. The buprenorphine segment, which includes Probuphine, is expected to lead the market during the forecast period, driven by its efficacy in treating opioid dependence and increasing adoption among healthcare providers and patients[1][3].

Future Prospects

Titan Pharmaceuticals is working to improve the uptake of Probuphine through focused market segmentation strategies and partnerships. For instance, the company is exploring options to expand global access through partnerships in Europe and other territories. This strategic approach is expected to enhance the product's market presence and financial performance in the coming years[2].

Competitive Landscape

The global OUD market is dominated by several key players, including Indivior PLC, Alkermes, and Orexo AB. However, Titan Pharmaceuticals, with its unique product offering in Probuphine, is positioned to carve out a significant niche in the market. The company's continuous R&D activities and strategic partnerships are crucial in maintaining its competitive edge[1].

Regional Market Performance

• North America: This region has been a strong market for Probuphine, driven by high awareness among healthcare experts and favorable reimbursement policies. The U.S. market, in particular, is expected to grow steadily due to the increasing prevalence of OUD and the need for effective therapeutics[1][3].
• Europe and Asia Pacific: These regions are also expected to contribute significantly to the growth of the OUD treatment market, including Probuphine. Increasing awareness and healthcare spending in these regions are key factors driving market expansion[1].

Challenges and Opportunities

Challenges

Despite its innovative delivery system, Probuphine faces challenges such as competition from other buprenorphine products and the need for continuous patient support and education. The transition in commercialization rights and the impact of the COVID-19 pandemic have also presented hurdles[1][2].

Opportunities

The growing demand for effective OUD treatments and the increasing focus on long-acting formulations present significant opportunities for Probuphine. Titan Pharmaceuticals' efforts to enhance market segmentation and expand global access are expected to drive the product's growth and financial performance[2][3].

Key Takeaways

• Innovative Delivery: Probuphine's unique subdermal implant delivery system provides continuous buprenorphine levels for six months, enhancing treatment adherence and outcomes.
• Market Growth: The OUD treatment market is growing, driven by increasing prevalence, government initiatives, and innovations in treatment options.
• Financial Prospects: Despite initial challenges, Probuphine is poised for growth, driven by strategic market focus and global expansion efforts.
• Competitive Edge: Titan Pharmaceuticals' continuous R&D and strategic partnerships position Probuphine competitively in the market.

FAQs

1. What is Probuphine and how does it work? Probuphine is a subdermal implant that delivers buprenorphine continuously for six months. It uses Titan's ProNeura™ drug delivery system, providing sustained blood levels of buprenorphine to treat opioid use disorder[2].

2. Who are the key players in the OUD treatment market? Key players include Indivior PLC, Alkermes, Orexo AB, and Titan Pharmaceuticals, with Probuphine being a unique offering from Titan[1].

3. What are the main drivers of the OUD treatment market? The market is driven by the increasing prevalence of OUD, government initiatives, and innovations in treatment options such as long-acting buprenorphine products[1][3].

4. How has the COVID-19 pandemic affected the OUD treatment market? The pandemic led to disruptions in the market, including a decline in sales for some products. However, the market is expected to recover and grow steadily during the forecast period[1].

5. What are the future prospects for Probuphine? Probuphine is expected to grow through focused market segmentation strategies, global expansion efforts, and continuous R&D activities. These strategies aim to improve the product's uptake and financial performance[2].

Sources

1. Fortune Business Insights - Opioid Use Disorder [OUD] Market Size, Share | Growth, 2032
2. Braeburn Rx - Titan Pharmaceuticals and Braeburn Announce Mutual Termination of License Agreement for Probuphine for Opioid Dependence
3. Grand View Research - Naltrexone And Buprenorphine Market Size Report, 2030