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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VANTRELA ER
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
Hong Kong	1193567	抗濫用藥物配方 (ABUSE RESISTANT DRUG FORMULATION)
Japan	5357032
European Patent Office	2692341	Préparation médicamenteuse empêchant l'utilisation abusive (Abuse resistant drug formulation)
Poland	2200593
Spain	2452033
Poland	2692341
Portugal	2692341

VANTRELA ER: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

VANTRELA ER, a once-daily extended-release formulation of tramadol hydrochloride, targets moderate to moderately severe pain. The drug's market positioning is defined by its generic availability, established efficacy profile, and its role within the broader opioid analgesic landscape. Financial performance hinges on prescription volume, pricing strategies, and market share relative to competitors, including other tramadol formulations and non-opioid alternatives.

What is the Approved Indication for VANTRELA ER?

VANTRELA ER is indicated for the management of moderate to moderately severe pain in adults. The extended-release formulation allows for less frequent dosing compared to immediate-release tramadol products, potentially improving patient adherence and convenience. The active pharmaceutical ingredient, tramadol, is a centrally acting synthetic opioid analgesic that also inhibits the reuptake of norepinephrine and serotonin.

The U.S. Food and Drug Administration (FDA) approved VANTRELA ER on October 29, 2010. It is manufactured by Depomed, Inc., a subsidiary of Assertio Holdings, Inc.

What is the Competitive Landscape for VANTRELA ER?

The market for pain management therapeutics is highly competitive, characterized by a range of pharmacological classes and individual agents. VANTRELA ER operates within the opioid analgesic segment, facing competition from:

• Other Tramadol Formulations: Immediate-release tramadol products, other extended-release tramadol formulations, and combination products containing tramadol with acetaminophen. Examples include generic tramadol hydrochloride extended-release tablets and Ultram ER (ortho-tryclofenac extended-release).
• Other Opioid Analgesics: A broad class of drugs including hydrocodone, oxycodone, morphine, and fentanyl. These drugs vary in potency, duration of action, and abuse potential.
• Non-Opioid Analgesics: This category includes acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, and adjuvant analgesics such as gabapentinoids and antidepressants.
• Novel Pain Therapeutics: Emerging treatments in development for chronic pain conditions, including non-opioid options and targeted therapies.

VANTRELA ER differentiates itself through its extended-release profile, aiming for consistent pain relief over a 24-hour period with a single daily dose. However, its efficacy and safety profile are generally considered comparable to other tramadol products.

What are the Key Market Drivers and Restraints for VANTRELA ER?

Several factors influence the market dynamics of VANTRELA ER:

Market Drivers:

• Prevalence of Chronic Pain: A significant and growing patient population suffers from chronic pain conditions, driving demand for effective analgesics. According to the Centers for Disease Control and Prevention (CDC), an estimated 20.4% of U.S. adults experience chronic pain [1].
• Convenience of Extended-Release Formulations: Once-daily dosing can improve patient compliance and reduce the burden of frequent medication administration, particularly for individuals managing chronic pain.
• Established Efficacy of Tramadol: Tramadol has a long history of clinical use and is recognized for its efficacy in managing moderate pain.
• Generic Availability: As a branded product with a generic equivalent, VANTRELA ER benefits from the accessibility and cost-effectiveness of generic pharmaceuticals, although its direct market share is impacted by generic competition.

Market Restraints:

• Opioid Prescription Regulations: Increasing regulatory scrutiny and efforts to curb opioid overprescription and misuse pose a significant restraint. This includes prescription drug monitoring programs (PDMPs), prescribing guidelines, and restrictions on opioid dosage and duration.
• Side Effect Profile: Like all opioids, tramadol carries risks of side effects, including nausea, dizziness, constipation, somnolence, and the potential for respiratory depression and addiction.
• Abuse Potential and Diversion: Tramadol, despite being classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA), still carries a risk of abuse and diversion, contributing to regulatory pressures.
• Growth of Non-Opioid Alternatives: Advancements in non-opioid pain management therapies are providing viable alternatives for some patient populations, reducing reliance on opioid analgesics.
• Payer Restrictions and Formulary Limitations: Insurance companies and pharmacy benefit managers (PBMs) may implement restrictions on opioid coverage, favoring lower-cost generics or non-opioid alternatives.

What is the Financial Performance and Revenue Outlook for VANTRELA ER?

Assessing the precise, standalone financial performance of VANTRELA ER is challenging as it is part of Assertio Holdings, Inc.'s broader portfolio. Assertio reports its revenue across several therapeutic areas, and VANTRELA ER is often grouped with other pain management products. However, its historical performance and market positioning provide insights into its likely financial trajectory.

As of the fourth quarter of 2022, Assertio Holdings, Inc. reported net revenue of $135.6 million. The company's pain management portfolio, which includes VANTRELA ER, is a significant contributor to its overall revenue.

Key Financial Considerations:

• Sales Volume: Prescription data from sources like IQVIA or Symphony Health Solutions would provide granular insights into VANTRELA ER's prescription volume, which is a primary driver of its revenue. While specific figures for VANTRELA ER are not always publicly disclosed by the manufacturer, trends in tramadol prescriptions overall can be indicative.
• Pricing: The Average Manufacturer Price (AMP) and net selling price to wholesalers are critical. Pricing strategies are influenced by competitive pressures, payer negotiations, and the drug's perceived value.
• Generic Competition: The presence of generic tramadol products significantly impacts the pricing power and market share of branded VANTRELA ER. Generic versions are typically priced at a substantial discount.
• Regulatory Impact: Changes in opioid prescribing regulations can directly affect demand and, consequently, revenue. Stricter guidelines can lead to reduced prescription volumes for all opioid analgesics.
• Portfolio Diversification: Assertio's strategy involves diversifying its product portfolio, which can buffer the impact of individual product performance fluctuations. VANTRELA ER's revenue contributes to this diversified income stream.

Revenue Outlook:

The revenue outlook for VANTRELA ER is likely to be characterized by stability rather than significant growth, primarily due to:

• Maturity: VANTRELA ER is a mature product in its market lifecycle.
• Generic Erosion: The ongoing impact of generic tramadol products will continue to limit opportunities for significant price increases or market share expansion for the branded version.
• Regulatory Headwinds: The unfavorable regulatory environment for opioid analgesics is expected to persist, potentially leading to further declines in overall opioid prescription volumes.
• Competition from Non-Opioids: The increasing adoption of non-opioid pain management strategies will continue to draw patients away from opioid therapies.

Assertio's focus on expanding its portfolio with other therapeutic areas, such as neurology and hospital-based products, suggests a strategic shift away from heavy reliance on established, mature pain management drugs like VANTRELA ER. This indicates that while VANTRELA ER will continue to contribute to revenue, it is unlikely to be a primary growth engine for the company.

What is the Patent Landscape and Exclusivity Status for VANTRELA ER?

Understanding the patent landscape is crucial for assessing the long-term commercial viability and competitive positioning of VANTRELA ER.

• Core Patents: The primary patents for VANTRELA ER would have covered its novel extended-release formulation and its manufacturing process.
• Exclusivity Periods: Upon FDA approval, VANTRELA ER was granted periods of market exclusivity based on patent protections and regulatory data exclusivity.
• Generic Entry: The expiration of key patents and regulatory exclusivities opens the door for generic manufacturers to introduce their own versions of tramadol extended-release products. This significantly impacts the pricing and market share of the branded product.
• Evergreening Strategies: Pharmaceutical companies sometimes employ strategies to extend patent life through new formulations, new indications, or new combination products. The success of such strategies depends on the novelty and patentability of these advancements.

Specific patent numbers and their expiration dates are critical for a precise analysis. However, general trends indicate that for a drug approved in 2010, most core patent exclusivities would have expired or be nearing expiration, allowing for broad generic competition.

Assertio Holdings, Inc.'s intellectual property strategy would involve monitoring the patent landscape for VANTRELA ER and its competitors, and potentially pursuing new patent filings if novel aspects are developed.

What are the Regulatory Considerations Affecting VANTRELA ER?

The regulatory environment for opioid analgesics is one of the most significant factors influencing VANTRELA ER.

• Controlled Substance Classification: Tramadol is classified as a Schedule IV controlled substance by the DEA. This designation imposes specific requirements for prescribing, dispensing, and record-keeping.
• FDA Post-Market Surveillance: The FDA actively monitors the safety of all approved drugs, including opioids. Any emerging safety concerns can lead to label changes, risk evaluation and mitigation strategies (REMS), or even market withdrawal.
• Opioid Crisis Response: Federal and state governments have implemented numerous initiatives to combat the opioid crisis. These include:
  • Prescribing Guidelines: Recommendations and mandates for limiting opioid prescriptions, particularly for acute pain.
  • Prescription Drug Monitoring Programs (PDMPs): State-level databases that track controlled substance prescriptions to prevent diversion and doctor shopping.
  • Limits on Opioid Dosage and Duration: Restrictions on the maximum daily dosage and length of opioid prescriptions.
  • Promotion of Non-Opioid Alternatives: Encouraging the use of non-opioid pain management strategies.
• DEA Quotas: The DEA sets annual production quotas for opioid raw materials, which can indirectly affect the availability and cost of opioid analgesics.

These regulatory measures collectively aim to reduce opioid prescribing and minimize harm. For VANTRELA ER, this translates to a more challenging prescribing environment and potentially lower demand.

Key Takeaways

VANTRELA ER is an established extended-release tramadol product operating in a competitive and highly regulated pain management market. Its market position is defined by the widespread availability of generic tramadol, the ongoing opioid crisis, and the increasing adoption of non-opioid pain therapies. While the convenience of its once-daily formulation remains an advantage, the overall market dynamics and regulatory pressures point to a mature product with limited growth potential. Assertio Holdings, Inc.'s financial performance will be influenced by its broader portfolio, but VANTRELA ER's contribution is likely to be stable, impacted by generic competition and evolving prescribing practices.

Frequently Asked Questions

1. When was VANTRELA ER first approved by the FDA? VANTRELA ER was approved by the U.S. Food and Drug Administration (FDA) on October 29, 2010.

2. What is the primary mechanism of action for tramadol, the active ingredient in VANTRELA ER? Tramadol is a centrally acting synthetic opioid analgesic that inhibits the reuptake of norepinephrine and serotonin.

3. What are the main challenges facing VANTRELA ER in the current market? The main challenges include intense generic competition, strict government regulations on opioid prescribing, the potential for abuse and diversion, and the growing availability of non-opioid pain management alternatives.

4. How does the extended-release formulation of VANTRELA ER benefit patients? The extended-release formulation allows for once-daily dosing, which can improve patient adherence to their pain management regimen and provide more consistent pain relief over a 24-hour period.

5. What is the DEA scheduling of tramadol? Tramadol is classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA).

Citations

[1] Dahlhamer, J., Lucas, J., Zelaya, C., Nahin, S., Sennblatt, L., & Peterson, S. (2018). Prevalence of chronic pain and high-impact chronic pain among adults – United States, 2016. MMWR. Morbidity and Mortality Weekly Report, 67(36), 1001–1006. https://doi.org/10.15585/mmwr.mm6736a2