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ZUBSOLV Drug Patent Profile

When do Zubsolv patents expire, and when can generic versions of Zubsolv launch?

Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. There are ten patents protecting this drug and four Paragraph IV challenges.

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

The generic ingredient in ZUBSOLV 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 Zubsolv

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

Summary for ZUBSOLV

International Patents:	60
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	6
Patent Applications:	279
Drug Prices:	Drug price information for ZUBSOLV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZUBSOLV
What excipients (inactive ingredients) are in ZUBSOLV?	ZUBSOLV excipients list
DailyMed Link:	ZUBSOLV at DailyMed

See drug prices for ZUBSOLV

Recent Clinical Trials for ZUBSOLV

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

Sponsor	Phase
Johns Hopkins University	Phase 2
Indivior Inc.	Phase 4
Orexo AB	Phase 4

See all ZUBSOLV clinical trials

Pharmacology for ZUBSOLV

Drug Class	Opioid Antagonist Partial Opioid Agonist
Mechanism of Action	Opioid Antagonists Partial Opioid Agonists

Paragraph IV (Patent) Challenges for ZUBSOLV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	0.7 mg/0.18 mg	204242	1	2017-05-04
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	2.9 mg/7.1 mg	204242	1	2015-12-21
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	8.6 mg/2.1 mg and 11.4 mg/2.9 mg	204242	1	2015-07-24
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	1.4 mg/0.36 mg and 5.7 mg/1.4 mg	204242	1	2013-10-22

US Patents and Regulatory Information for ZUBSOLV

ZUBSOLV is protected by ten US patents.

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	204242-003	Dec 11, 2014		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y

Expired US Patents for ZUBSOLV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013

International Patents for ZUBSOLV

When does loss-of-exclusivity occur for ZUBSOLV?

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

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

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 ZUBSOLV around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	365540
Cyprus	1124764
Portugal	2805716
Hungary	230342	Gyógyszerkészítmény akut rendellenességek kezelésére (Pharmaceutical composition for the treatment of acute disorders)
Sweden	9803240
Cyprus	1116270
Canada	2345121	COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES MALADIES AIGUES (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS)

Supplementary Protection Certificates for ZUBSOLV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	484	Finland
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718

ZUBSOLV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zubsolv

Introduction

Zubsolv, a buprenorphine/naloxone sublingual tablet, has been a significant player in the opioid use disorder treatment market. Here, we delve into the market dynamics and financial trajectory of Zubsolv, highlighting its performance, market position, and future outlook.

Market Position of Zubsolv

Zubsolv is one of the leading branded drugs in the buprenorphine/naloxone market, which is expected to hold a 36% share of the opioid use disorder treatment market by 2022[4].

Market Growth

In Q2 2018, Zubsolv outpaced the market growth, with a 20.3% increase in prescriptions compared to the same quarter in 2017. It also grew 8.6% quarter-over-quarter, while the market grew 7.0%[1].

Competitive Advantage

Zubsolv has the best commercial access among buprenorphine/naloxone products, with nearly universal reimbursement in the commercial segment. It holds exclusive formulary positions with major health plans such as Humana Medicare Part D and Envision Rx, which significantly contribute to its market share[1].

Financial Performance

Revenue Growth

In Q2 2018, Zubsolv's US net revenue was SEK 158.4 million, up from SEK 124.1 million in Q2 2017, representing a growth of over 20%[1]. For the full year 2018, Zubsolv's net revenue was SEK 537.1 million, driving the total revenue growth of Orexo by 25%[1].

Recent Financials

In Q4 2023, Zubsolv's net sales continued to be strong, growing more than 6% year-over-year in both SEK and USD, and nearly 8% quarter-over-quarter. The US Pharma segment, which includes Zubsolv, generated net revenues of SEK 151.3 million for Q4 2023, with an EBIT margin of 49%[2][5].

Cost and Operational Efficiency

Orexo has been focusing on reducing the cost of goods and operating expenses. In 2018, the company started seeing the effects of cost reduction efforts, which contributed to improved profitability[1].

Recent Cost Control Measures

In 2023, Orexo reduced operating expenses by 23% from the previous year, which was a key factor in achieving a positive EBITDA in the second half of the year. The company aims to continue this trend, targeting an operating expense reduction below SEK 530 million in 2024[2][5].

Market Outlook and Projections

Market Growth Trajectory

The buprenorphine/naloxone market is expected to grow at a rate of 2-5% based on current trends. This growth is driven by an increasing number of patients seeking treatment for opioid use disorder[2].

Zubsolv Sales Projections

For 2024, Zubsolv's net sales in USD are expected to be in line with 2023 levels. This stability is crucial for Orexo's financial performance, especially as the company aims to achieve positive EBITDA for the full year 2024[2].

Reimbursement and Formulary Positions

Zubsolv's success is heavily influenced by its reimbursement status and formulary positions. The drug has maintained strong formulary positions, including exclusivity with Humana Medicare Part D and significant market share in Envision Rx[1].

Impact of Exclusive Contracts

Exclusive contracts have been a significant driver of Zubsolv's market share. However, the impact can vary depending on the health plans' ability to control prescriptions. For instance, Zubsolv achieved market shares above 75% with United Health Group and WellCare, but only around 40% in Maryland[1].

Challenges and Opportunities

Market Competition

The opioid use disorder treatment market is competitive, with other branded drugs like SUBLOCADE and SUBOXONE. However, Zubsolv's strong commercial access and formulary positions have helped it maintain a competitive edge[4].

Currency and Market Fluctuations

Orexo faces challenges from currency fluctuations, which can impact its financial performance. Despite these headwinds, the company has managed to meet its financial guidance and is confident about achieving positive EBITDA in 2024[2][5].

CEO Comments and Strategic Focus

The CEO of Orexo has expressed satisfaction with the Q4 2023 results, highlighting the strong recovery in financial performance and the continued drive for efficiencies across the business. The company is focusing on integrating digital mental health programs into its US Pharma operations to enhance overall profitability[2][5].

Key Takeaways

• Market Leadership: Zubsolv has consistently outpaced market growth and maintained a strong market position.
• Financial Performance: Zubsolv has driven significant revenue growth and profitability for Orexo.
• Cost Efficiency: Orexo has successfully reduced operating expenses, contributing to improved financial performance.
• Market Outlook: The buprenorphine/naloxone market is expected to grow at a rate of 2-5%, with Zubsolv's sales projected to remain stable.
• Reimbursement and Formulary: Strong formulary positions and reimbursement status are crucial for Zubsolv's market share.

FAQs

What is Zubsolv used for?

Zubsolv is used for the treatment of opioid dependence. It is a buprenorphine/naloxone sublingual tablet.

How has Zubsolv performed in the market?

Zubsolv has outpaced market growth, with significant increases in prescriptions and revenue. It has maintained a strong market position due to its commercial access and formulary positions.

What are the key drivers of Zubsolv's market share?

Exclusive formulary positions with major health plans and nearly universal reimbursement in the commercial segment are key drivers of Zubsolv's market share.

How has Orexo managed to improve its financial performance?

Orexo has improved its financial performance through cost reduction efforts, reduced operating expenses, and strong sales of Zubsolv.

What are the projections for Zubsolv's sales in 2024?

Zubsolv's net sales in USD are expected to be in line with 2023 levels, contributing to Orexo's aim for positive EBITDA in 2024.

Sources

1. Orexo Interim Report Q2 2018 - Cision
2. Orexo Interim Report Q4 2023, incl. Full Year Report - PR Newswire
3. Capital Markets Day - Indivior
4. Opioid Use Disorder Market - Virtu Market Research
5. Positive EBITDA in H2 setting the target for FY 2024 - MFN.se