OPVEE Drug Patent Profile

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

Opvee is a drug marketed by Indivior and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in eight countries.

The generic ingredient in OPVEE is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Opvee

A generic version of OPVEE was approved as nalmefene hydrochloride by PURDUE PHARMA LP on February 8^th, 2022.

Summary for OPVEE

International Patents:	12
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for OPVEE
What excipients (inactive ingredients) are in OPVEE?	OPVEE excipients list
DailyMed Link:	OPVEE at DailyMed

See drug prices for OPVEE

Pharmacology for OPVEE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for OPVEE

OPVEE is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470-001	May 22, 2023		RX	Yes	Yes	11,458,091		Y
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470-001	May 22, 2023		RX	Yes	Yes

International Patents for OPVEE

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2769397	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ (COMPOSITIONS AND METHODS OF TREATING OPIOID OVERDOSE)
Canada	3044221	COMPOSITIONS ET METHODES DE TRAITEMENT D'UNE PRISE EXCESSIVE D'OPIOIDES (INTRANASAL NALMEFENE COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE)
Russian Federation	2019118465	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ
China	110139651	用于治疗阿片样物质过量的组合物和方法 (COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE)
Australia	2017360910	Compositions and methods for the treatment of opioid overdose

OPVEE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OPVEE

Introduction to OPVEE

OPVEE, a novel opioid overdose reversal agent developed by Indivior, has been making significant waves in the healthcare and pharmaceutical industries. Here’s a detailed look at the market dynamics and financial trajectory of this promising drug.

The Need for Effective Opioid Overdose Reversal Agents

The opioid epidemic, particularly the rise in synthetic opioid overdoses, has created a critical need for more effective reversal agents. Traditional treatments like naloxone have shown limitations, especially against potent synthetic opioids such as fentanyl and carfentanil[1].

Comparative Effectiveness of OPVEE

Recent studies have highlighted OPVEE's superior performance compared to naloxone. A study published in a peer-reviewed journal found that a single dose of OPVEE (2.7mg) significantly reduced the incidence of simulated cardiac arrest in fentanyl and carfentanil overdoses. In chronic opioid users, OPVEE reduced the cardiac arrest rate to 12% compared to 47% with single-dose naloxone[1].

Market Opportunity

Given the increasing number of synthetic opioid overdoses, the market demand for effective reversal agents is on the rise. OPVEE's effectiveness positions it as a strong contender to capture a significant market share, potentially displacing naloxone as the standard treatment[1].

Target Market and Customer Base

The primary target market for OPVEE includes healthcare providers, emergency responders, and public health agencies. The drug's adoption is expected to be driven by its superior efficacy in reversing synthetic opioid overdoses, which are becoming increasingly common.

Financial Outlook

Current Revenue and Projections

As of the second quarter of 2024, OPVEE's net revenue was immaterial, less than $1 million. However, Indivior expects OPVEE's revenue to grow significantly, driven primarily by the fulfillment of the first delivery under a 10-year contract with the Biomedical Advanced Research and Development Authority (BARDA), valued at approximately $8 million[2].

For the full year 2024, Indivior projects OPVEE's net revenue to be between $9 million and $14 million, with further growth anticipated in subsequent years. The company expects OPVEE to contribute substantially to its financial performance once it gains traction among healthcare providers and emergency responders[2].

Regulatory and Market Approval

The publication of OPVEE's efficacy data in a peer-reviewed journal adds significant scientific validation, which could accelerate regulatory approvals and market penetration. This validation is crucial for securing broader acceptance and adoption of OPVEE[1].

Competitive Landscape

Comparison with Naloxone

OPVEE's superior performance in reducing cardiac arrest incidence gives it a strong competitive advantage over naloxone. While naloxone has been the standard treatment for opioid overdoses, its limited effectiveness against synthetic opioids presents a substantial opportunity for OPVEE to capture market share[1].

Integration with Other Indivior Products

Indivior's portfolio includes other addiction-focused treatments like SUBLOCADE, which is expected to achieve a net revenue run rate of $1 billion by the end of 2025. The integration of OPVEE into this portfolio enhances Indivior's overall market position and ability to address the opioid epidemic comprehensively[2].

Challenges and Considerations

Cost and Accessibility

While OPVEE has shown superior efficacy, its higher cost compared to naloxone could be a barrier to widespread adoption. Indivior will need to navigate pricing strategies and work with payors to ensure that OPVEE is accessible to those who need it[1].

Regulatory and Legal Factors

Indivior is also dealing with regulatory and legal challenges, including a recent settlement with end payor plaintiffs. These factors can impact the company's financial performance and must be managed carefully to ensure the successful launch and adoption of OPVEE[2].

Market Size and Growth Potential

The global opioids market, which includes reversal agents, is projected to grow significantly. By 2030, the opioid drugs market is expected to surpass $56.5 billion, and by 2034, the global opioids market is anticipated to reach around $26.78 billion, growing at a CAGR of 1.5% from 2024 to 2034[3][4].

Key Takeaways

• Superior Efficacy: OPVEE has shown significant effectiveness in reversing synthetic opioid overdoses compared to naloxone.
• Market Opportunity: The rising incidence of synthetic opioid overdoses creates a substantial market opportunity for OPVEE.
• Financial Projections: OPVEE's revenue is expected to grow, driven by contracts like the one with BARDA, and is projected to contribute significantly to Indivior's financial performance.
• Competitive Advantage: OPVEE's superior performance gives it a strong competitive edge in the market.
• Challenges: Higher costs and regulatory factors need to be managed to ensure widespread adoption.

FAQs

Q: What is OPVEE, and how does it differ from naloxone?

A: OPVEE is a novel opioid overdose reversal agent that has shown superior efficacy in reversing synthetic opioid overdoses compared to naloxone, particularly in reducing cardiac arrest incidence.

Q: What are the financial projections for OPVEE in 2024?

A: For 2024, Indivior projects OPVEE's net revenue to be between $9 million and $14 million, primarily driven by the fulfillment of the first delivery under a 10-year contract with BARDA.

Q: How does OPVEE fit into Indivior's overall product portfolio?

A: OPVEE is part of Indivior's addiction-focused portfolio, which includes other treatments like SUBLOCADE. This integration enhances Indivior's ability to comprehensively address the opioid epidemic.

Q: What are the potential barriers to OPVEE's adoption?

A: Higher costs compared to naloxone and regulatory factors could be barriers to widespread adoption. Indivior must navigate these challenges to ensure OPVEE's accessibility.

Q: What is the projected growth of the opioids market, and how does OPVEE fit into this?

A: The global opioids market is expected to grow significantly, with projections exceeding $56.5 billion by 2030 and $26.78 billion by 2034. OPVEE's superior efficacy positions it to capture a significant share of this growing market.

Sources

1. Indivior Announces the Publication of New Data on the Comparative Efficacy of OPVEE and Naloxone. Stock Titan, June 18, 2024.
2. Indivior Provides Business Update. Investis, July 9, 2024.
3. Opioid Drugs Market to Surpass $56.5 billion by 2030. GlobeNewswire, November 29, 2023.
4. Opioids Market Size to Worth Around USD 26.78 Billion by 2034. BioSpace, July 17, 2024.