VANTRELA ER Drug Patent Profile

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

Vantrela Er is a drug marketed by Teva Branded Pharm and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-three patent family members in thirteen countries.

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vantrela Er

A generic version of VANTRELA ER was approved as hydrocodone bitartrate by ALVOGEN on January 21^st, 2020.

Summary for VANTRELA ER

International Patents:	33
US Patents:	3
Applicants:	1
NDAs:	1
DailyMed Link:	VANTRELA ER at DailyMed

US Patents and Regulatory Information for VANTRELA ER

VANTRELA ER 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
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-001	Jan 17, 2017		DISCN	Yes	No	9,216,176		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-003	Jan 17, 2017		DISCN	Yes	No	9,216,176		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-002	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-004	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-003	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-005	Jan 17, 2017		DISCN	Yes	No	9,216,176		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-001	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y

International Patents for VANTRELA ER

When does loss-of-exclusivity occur for VANTRELA ER?

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

Canada

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Mexico

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 VANTRELA ER around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011504455
Spain	2452033
Poland	2073795
Japan	2011517654
Portugal	2073795
Canada	2699142	FORMULATION MEDICAMENTEUSE CONTRE L'ABUS (ABUSE RESISTANT DRUG FORMULATION)
World Intellectual Property Organization (WIPO)	2008033523

VANTRELA ER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for VANTRELA ER

Introduction

VANTRELA ER, an extended-release (ER) formulation of hydrocodone bitartrate, is a significant player in the opioid market, particularly designed for the management of severe, chronic pain. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Context

The global opioids market is substantial and growing. As of 2023, the market size was valued at $22.74 billion and is projected to reach $26.78 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 1.5% from 2024 to 2034[3].

Product Characteristics and Indications

VANTRELA ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, where alternative treatment options are inadequate. It is available in 15, 30, 45, 60, and 90 mg strengths and is designed to be taken every 12 hours[1][4].

Abuse-Deterrent Features

One of the key differentiators of VANTRELA ER is its abuse-deterrent formulation. The drug is designed with a unique technology that maintains its extended-release properties even when manipulated, such as being crushed or dissolved. This reduces the potential for abuse via oral and intranasal routes, showing significantly lower drug liking and willingness to take the drug again compared to non-abuse-deterrent opioids[1][4].

Clinical Data and Safety Profile

Clinical studies have demonstrated that VANTRELA ER provides significant pain relief compared to placebo, with a safety profile similar to other ER opioid products. The drug has been shown to reduce worst pain intensity and average pain intensity effectively. However, it also comes with common adverse effects associated with opioids, such as constipation, nausea, headache, and somnolence[1].

Regulatory Requirements and REMS

The FDA has mandated a Risk Evaluation and Mitigation Strategy (REMS) for VANTRELA ER to ensure its safe use. This includes elements such as prescriber training, a Medication Guide, and ongoing assessments to monitor the drug's impact on misuse, abuse, and addiction. The REMS also requires post-marketing studies to assess the serious risks associated with long-term use of ER/LA opioid analgesics[2].

Market Share and Geographic Distribution

North America currently holds the highest market share in the global opioids market, with 45.13% in 2023. However, the Asia-Pacific region is expected to expand at the fastest CAGR during the forecast period. The oral segment, which includes VANTRELA ER, is anticipated to grow significantly, driven by the need for effective pain management solutions[3].

Financial Trajectory

Given the growing demand for pain management solutions and the specific need for abuse-deterrent opioids, VANTRELA ER is positioned to capture a significant share of the market. The drug's unique formulation and regulatory approvals are likely to contribute to its financial success. Here are some key financial insights:

• Market Growth: The overall opioids market is expected to grow, and VANTRELA ER, with its abuse-deterrent features, is likely to benefit from this trend.
• Revenue Share: The oral segment, which includes VANTRELA ER, held a significant revenue share in 2023 and is expected to continue growing at a CAGR of 2.5% over the predicted period[3].
• Competitive Advantage: The abuse-deterrent properties of VANTRELA ER provide a competitive edge, potentially increasing its market share and revenue.

Challenges and Opportunities

Despite its potential, VANTRELA ER faces several challenges:

• Regulatory Scrutiny: Opioids are under intense regulatory scrutiny due to their potential for abuse and addiction. Compliance with REMS and ongoing post-marketing studies are crucial.
• Market Competition: The opioids market is highly competitive, with various products available. Differentiating VANTRELA ER through its abuse-deterrent features is essential.
• Public Health Concerns: The opioid crisis remains a significant public health concern, which can impact market dynamics and public perception of opioid products.

However, there are also opportunities:

• Growing Demand for Pain Management: The increasing need for effective pain management solutions, especially in areas like cancer treatment and end-of-life care, presents a growing market for VANTRELA ER.
• Innovation in Abuse-Deterrent Technologies: Continued innovation in abuse-deterrent technologies can further enhance the product's market position.

Key Takeaways

• VANTRELA ER is an extended-release hydrocodone bitartrate tablet with abuse-deterrent properties.
• It is indicated for severe, chronic pain management where alternative treatments are inadequate.
• The drug has a unique formulation that maintains its extended-release profile even when manipulated.
• Regulatory requirements, including REMS, are in place to ensure safe use.
• The market for opioids is growing, with the oral segment expected to expand significantly.
• VANTRELA ER faces challenges such as regulatory scrutiny and market competition but also has opportunities driven by growing demand for pain management solutions.

FAQs

Q: What is the primary indication for VANTRELA ER? A: VANTRELA ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Q: How does VANTRELA ER deter abuse? A: VANTRELA ER is designed with a unique abuse-deterrent technology that maintains its extended-release properties even when manipulated, reducing the potential for abuse via oral and intranasal routes.

Q: What are the common adverse effects of VANTRELA ER? A: Common adverse effects include constipation, nausea, headache, somnolence, and others typical of opioid use.

Q: Is VANTRELA ER subject to any specific regulatory requirements? A: Yes, VANTRELA ER is subject to a Risk Evaluation and Mitigation Strategy (REMS) to ensure its safe use, including prescriber training and ongoing post-marketing studies.

Q: How is the market for VANTRELA ER expected to grow? A: The market for VANTRELA ER is expected to grow as part of the broader opioids market, driven by increasing demand for effective pain management solutions and the drug's unique abuse-deterrent features.

Cited Sources

1. FDA: Vantrela™ ER (hydrocodone bitartrate) Abuse Deterrent Extended Release Tablets[1].
2. FDA: VANTRELA ER (hydrocodone bitartrate) extended-release tablets[2].
3. Biospace: Opioids Market Size to Worth Around USD 26.78 Billion by 2034[3].
4. FDA: vantrelatm er (hydrocodone bitartrate)[4].