BELBUCA Drug Patent Profile

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

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

This drug has seventy-six patent family members in twenty-seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Belbuca

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

Summary for BELBUCA

International Patents:	76
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	9
Patent Applications:	2
Drug Prices:	Drug price information for BELBUCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELBUCA
What excipients (inactive ingredients) are in BELBUCA?	BELBUCA excipients list
DailyMed Link:	BELBUCA at DailyMed

See drug prices for BELBUCA

Recent Clinical Trials for BELBUCA

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

Sponsor	Phase
Carolinas Pain Institute	Phase 4
BioDelivery Sciences International	Phase 4
Medical College of Wisconsin	Phase 2

See all BELBUCA clinical trials

Pharmacology for BELBUCA

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Paragraph IV (Patent) Challenges for BELBUCA

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 BELBUCA

BELBUCA is protected by three 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	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015		RX	Yes	No	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015		RX	Yes	No	9,655,843		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	9,901,539

Expired US Patents for BELBUCA

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

International Patents for BELBUCA

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

Country	Patent Number	Title	Estimated Expiration
Ukraine	118540	ПРИСТРОЇ ДЛЯ ТРАНСМУКОЗАЛЬНОЇ ДОСТАВКИ ЛІКІВ ДЛЯ ЗАСТОСУВАННЯ У ПОЛЕГШЕННІ ХРОНІЧНОГО БОЛЮ (TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF)
Portugal	1079813
Australia	2021202042	Transmucosal drug delivery devices for use in chronic pain relief

Market Dynamics and Financial Trajectory for BELBUCA

Introduction

BELBUCA, a buprenorphine buccal film, is a significant player in the pharmaceutical market, particularly in the realm of chronic pain management and opioid use disorder (OUD) treatment. Here, we delve into the market dynamics and financial trajectory of BELBUCA, highlighting its growth, market position, and future prospects.

FDA Approval and Market Entry

BELBUCA received FDA approval in 2016 for the management of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment, where alternative treatment options are inadequate. This approval was based on data from two placebo-controlled, randomized Phase 3 studies that demonstrated significant patient-reported pain relief with minimal opioid-like side effects[4].

Mechanism and Dosage

BELBUCA is a mu-opioid receptor partial agonist, utilizing BioDelivery Sciences International's (BDSI) BioErodible MucoAdhesive (BEMA) technology. It is available in seven dosage strengths, allowing for flexible dosing from 75 μg to 900 μg every 12 hours. This flexibility enables physicians to titrate the dose individually for patients to achieve adequate analgesia with minimal side effects[4].

Market Growth and Revenue

The financial performance of BELBUCA has been robust. In the second quarter of 2024, BELBUCA achieved record revenue of $52.2 million, representing a 21% increase year-over-year. This growth is attributed to an increase in total prescriptions, which rose by 2.1% year-over-year and 1.4% quarter-over-quarter[2][5].

Prescription Trends

The prescription trends for BELBUCA indicate a steady and growing demand. The increase in prescriptions is a result of several factors, including high awareness among healthcare professionals about the drug's efficacy in managing chronic pain and its role in OUD treatment. The drug's unique delivery mechanism and the flexibility in dosing also contribute to its popularity[2][5].

Competitive Landscape

BELBUCA operates in a competitive market, but its unique characteristics and strong commercial support have helped it maintain a significant market share. Collegium Pharmaceutical, the company behind BELBUCA, has a diversified pain management portfolio that includes other successful products like Xtampza ER and Nucynta. This diversified portfolio strengthens Collegium's position in the market and supports the growth of BELBUCA[3].

Financial Performance of Collegium Pharmaceutical

Collegium Pharmaceutical's overall financial performance is closely tied to the success of BELBUCA. In the second quarter of 2024, Collegium reported net revenues of $145.3 million, a 7% increase from the previous year. The company's adjusted EBITDA grew by 12% to $96.0 million, and GAAP net income increased by 51% to $19.6 million. These financial metrics reflect the company's strong cash generation and disciplined expense management[2][5].

Strategic Initiatives and Acquisitions

Collegium Pharmaceutical has been active in strategic initiatives and acquisitions to further bolster its market position. The company is set to acquire Ironshore Therapeutics in the third quarter of 2024, adding Jornay PM to its portfolio and expanding into the ADHD market. This move, along with other business development strategies, is expected to drive long-term value creation and diversify the company's revenue streams[2][3].

Debt Management and Capital Deployment

Collegium has a strong track record of managing its debt and deploying capital effectively. The company secured a new term loan of $646 million, reducing its cost of capital by 300 basis points. This financial maneuvering helps in maintaining a healthy balance sheet and supports the company's growth initiatives[2][3].

Market Outlook and Future Prospects

The market outlook for BELBUCA is promising, driven by increasing demand for effective chronic pain management and OUD treatment options. The global naltrexone and buprenorphine market, which includes BELBUCA, is projected to grow at a CAGR of 12.41% from 2024 to 2030, driven by factors such as the rising prevalence of substance use disorders and expanding government initiatives to combat the opioid crisis[1].

Regional Performance

In North America, which accounted for 39.39% of the naltrexone and buprenorphine market in 2023, BELBUCA is expected to continue its growth trajectory. The region's favorable reimbursement policies, increasing awareness of current treatments, and improved patient affordability are key drivers of this growth[1].

Conclusion

BELBUCA's market dynamics and financial trajectory are characterized by strong growth, driven by its unique delivery mechanism, flexible dosing options, and the increasing demand for chronic pain and OUD treatments. Collegium Pharmaceutical's strategic initiatives, robust financial performance, and effective capital deployment further support the drug's market position and future prospects.

Key Takeaways

• Record Revenue: BELBUCA achieved record revenue of $52.2 million in Q2 2024, up 21% year-over-year.
• Prescription Growth: Total prescriptions for BELBUCA increased by 2.1% year-over-year and 1.4% quarter-over-quarter.
• Market Position: BELBUCA operates within a diversified pain management portfolio, strengthening its market share.
• Financial Performance: Collegium Pharmaceutical reported strong net revenues and adjusted EBITDA growth.
• Strategic Initiatives: Acquisitions and debt management strategies support long-term value creation.
• Market Outlook: The global naltrexone and buprenorphine market is projected to grow significantly, driven by increasing demand for OUD treatments.

FAQs

1. What is BELBUCA used for? BELBUCA is used for the management of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment, where alternative treatment options are inadequate.

2. How does BELBUCA work? BELBUCA is a mu-opioid receptor partial agonist that utilizes BioErodible MucoAdhesive (BEMA) technology for its delivery.

3. What are the dosage options for BELBUCA? BELBUCA is available in seven dosage strengths, ranging from 75 μg to 900 μg every 12 hours.

4. Who is the manufacturer of BELBUCA? BELBUCA is manufactured by Collegium Pharmaceutical, although it was initially developed by BioDelivery Sciences International (BDSI) and distributed by Endo Pharmaceuticals.

5. What are the financial highlights of BELBUCA in Q2 2024? In Q2 2024, BELBUCA achieved record revenue of $52.2 million, a 21% increase year-over-year, with total prescriptions growing by 2.1% year-over-year and 1.4% quarter-over-quarter.

Sources

1. Grand View Research - Naltrexone And Buprenorphine Market Size Report, 2030
2. Stock Titan - Collegium Reports Second Quarter 2024 Financial Results
3. Collegium Pharmaceutical - Investor Presentation
4. BioSpace - BioDelivery Announces The Launch Of BELBUCA (buprenorphine) Buccal Film
5. Collegium Pharmaceutical - Collegium Reports Second Quarter 2024 Financial Results