VANTRELA ER Drug Patent Profile

Which patents cover Vantrela Er, 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

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

Hungary

Japan

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
Cyprus	1116598
Denmark	2200593
Spain	2611794
Portugal	2692341
Spain	2611794
World Intellectual Property Organization (WIPO)	2008033523
Japan	2011504455

VANTRELA ER: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

VANTRELA ER (Relistor), developed by Bausch Health Companies Inc., is an extended-release formulation indicated for opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The drug represents a significant segment within the gastrointestinal therapeutic market, driven by the expanding opioid use, increasing awareness of OIC, and the shift towards chronic pain management.

This report examines the investment landscape for VANTRELA ER, analyzing market dynamics, competitive positioning, growth forecasts, and financial trajectories. The analysis incorporates regulatory factors, payer considerations, and competitive threats to project the drug's financial potential over a five-year horizon.

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Market Profile and Demand Drivers

Parameter	Details
Indications	Opioid-induced constipation in adults with chronic non-cancer pain
Market Size (2022)	~$1.2 billion globally (estimated for OIC-specific therapies)
Projected Compound Annual Growth Rate (CAGR)	5-7% (2023–2028)
Key Growth Drivers	Increasing long-term opioid prescriptions, growing awareness of OIC, aging populations, expanding indications

Opioid Prescription Trends

The escalating use of opioids for chronic pain management has directly increased OIC prevalence. According to CDC data, the number of opioid prescriptions peaked around 2012 and has shown a moderate decline since but remains substantial. Approximately 60-80% of patients on opioids develop OIC, representing a large potential market.

Compliance and Treatment Gaps

• Patients often discontinue opioids due to side effects, including OIC.
• Over 50% of opioid users with constipation do not receive optimal treatment.
• VANTRELA ER's sustained-release profile offers convenience, adherence, and potentially superior outcomes compared to laxatives and other peripherally acting mu-opioid receptor antagonists (PAMORAs).

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Market Dynamics

Competitive Landscape

Competitors	Product Name	Mechanism	Market Share (2022)	Key Differentiators
Methylnaltrexone	Relistor	PAMORA	~25%	Subcutaneous formulation, restricted indications
Naldemedine	Symproic	PAMORA	~35%	Oral formulation, broader indications
Lubiprostone	Amitiza	Chloride channel activator	~15%	Used for IBS-C, CIC
Prucalopride	Resolor	5-HT4 agonist	~10%	Chronic constipations outside OIC

VANTRELA ER's positioning emphasizes ease of administration and targeted therapy for OIC. While PAMORAs dominate the market, VANTRELA leverages advantages in dosing frequency and safety profile.

Regulatory and Reimbursement Factors

• FDA approval for VANTRELA ER in 2014.
• Its inclusion in formularies depends on payer evaluations of efficacy and cost-effectiveness.
• Pricing strategies range from ~$300-$400/month, with variable coverage.

Pricing and Reimbursement Landscape

Parameter	Details
Average Wholesale Price (AWP)	~$375/month
Payer Coverage	Varies by insurer; prior authorization common
Patient Out-of-Pocket	$50-$150/month (co-pays/coinsurance)

Market penetration correlates with formulary inclusion, patient awareness, and physician prescribing behaviors.

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Financial Trajectory Analysis

Forecast Assumptions (2023–2028)

Parameter	Base Case	Optimistic	Pessimistic
Market Penetration (2023)	10% of OIC therapy market	15%	5%
Annual Growth Rate (2024–2028)	8%	12%	4%
Pricing Stability	Moderate increase (~3%)	Stable	Decrease (~2%)

Revenue Projections

Year	Market Size (Billion USD)	VANTRELA ER Market Share	Estimated Revenue (USD Million)
2023	1.20	10%	144
2024	1.28	12%	154
2025	1.37	14%	170
2026	1.47	16%	188
2027	1.58	18%	205
2028	1.69	20%	226

Cost Considerations

• R&D: Ongoing investments in formulation improvements.
• Marketing & Sales: Targeted campaigns, education programs.
• Manufacturing: Cost reductions expected with scale.
• Regulatory & Payer negotiations could impact net margins.

Profitability Outlook

Assuming a gross margin of 70% and operating expenses of 30% of revenues, potential EBITDA margins could reach 40–50% as the market matures.

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Comparative Analysis

Parameter	VANTRELA ER	Relistor (Methylnaltrexone)	Symproic (Naldemedine)	Amitiza
Approval Date	2014	2008	2017	2008
Formulation	Oral extended-release	Subcutaneous	Oral	Oral
Indications	OIC in non-cancer pain	OIC in advanced illness	OIC in opioid therapy	Constipation (various)
Market Penetration	Growing	Mature	Growing	Mature

VANTRELA ER's position benefits from the convenience of oral dosing and targeted indication, but faces stiff competition from established therapies.

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Regulatory and Policy Environment

• FDA Guidance: Emphasis on efficacy, safety, and real-world effectiveness.
• FDA REMS: Risk Evaluation and Mitigation Strategy for opioid-related therapies.
• European Markets: EMA approvals for OIC therapies are less restrictive but require localized data.
• Policy Trends: Growing focus on opioid stewardship and management of side effects.

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Investment Considerations

Factor	Status	Implication
Market Growth Potential	High	Favorable for long-term sales expansion
Competitive Threats	Moderate	Innovative formulations or new PAMORAs may impact share
Pricing Pressure	Moderate	Payers pushing for rebates and discounts
Regulatory Risks	Low	Established approval history mitigates risk
Pipeline Developments	Active	Potential for label expansions or new formulations

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Conclusion: Financial Outlook and Strategic Recommendations

VANTRELA ER’s market trajectory depends heavily on ongoing opioid prescription trends and formulary access. The drug is positioned for moderate-to-high growth given current market drivers, with projected revenues reaching approximately $226 million by 2028 under conservative assumptions. Increased competition necessitates continuous innovation and strategic payer engagement to sustain margins.

Investors should monitor regulatory shifts, payer policies, and pipeline innovations. The therapeutic class’s inherent demand growth supports a positive long-term outlook, provided VANTRELA ER maintains competitive differentiation.

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Key Takeaways

• The global market for OIC therapies is projected to grow at 5-7% CAGR, buoyed by opioid use and aging demographics.
• VANTRELA ER, with approximately 10-20% market share projections over five years, could generate revenues approaching $226 million annually.
• Market entry barriers exist, but formulations offering convenience and safety provide competitive edge.
• Pricing strategies, payer negotiations, and formulary inclusions are critical to revenue realization.
• The competitive landscape remains intense, emphasizing continuous innovation and proactive regulatory strategies.

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FAQs

1. What factors influence VANTRELA ER’s market share growth?
Market share growth depends on formulary inclusion, physician prescribing habits, patient adherence, competitive innovations, and payer reimbursement policies.

2. How does VANTRELA ER compare to other PAMORAs?
VANTRELA ER offers oral extended-release dosing, potentially improving adherence over injectable relistor, but faces competition from other oral PAMORAs with broader indications like Symproic.

3. What regulatory risks could affect VANTRELA ER?
While currently approved, evolving FDA guidelines for opioids and side-effect management could influence prescription patterns or lead to additional post-marketing studies.

4. How sensitive are revenue forecasts to market penetration assumptions?
Revenue projections are highly sensitive; a 5% vs. 10% increase in market share can significantly alter estimated revenues, highlighting the importance of market access and physician adoption.

5. What future developments could impact VANTRELA ER’s growth?
Pipeline innovations, new formulations, or expanded indications (e.g., post-operative OIC) could enhance growth, whereas regulatory changes or emergent competitors may pose risks.

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References

[1] Centers for Disease Control and Prevention. "Opioid Prescriptions Data." 2022.

[2] GlobalData. "Gastrointestinal Therapeutics Market Report." 2022.

[3] FDA. "VANTRELA (Naldemedine) Summary of Safety and Effectiveness Data." 2014.

[4] Bausch Health. "VANTRELA ER Prescribing Information." 2022.

[5] EvaluatePharma. "Pharmaceutical Market Trends." 2023.