Drug Price Trends for NDC 00024-5919

Average Pharmacy Cost for 00024-5919

Drug Name	NDC	Price/Unit ($)	Unit	Date
DUPIXENT 200 MG/1.14 ML PEN	00024-5919-02	1772.99139	ML	2026-01-01
DUPIXENT 200 MG/1.14 ML PEN	00024-5919-02	1688.56323	ML	2025-12-17
DUPIXENT 200 MG/1.14 ML PEN	00024-5919-02	1688.94627	ML	2025-11-19
DUPIXENT 200 MG/1.14 ML PEN	00024-5919-02	1689.00946	ML	2025-10-22

Best Wholesale Price for NDC 00024-5919

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
DUPIXENT 200MG/1.14ML,PEN 2PK	Sanofi Aventis U.S. LLC	00024-5919-02	2x1.14ML	2460.69		2023-06-01 - 2028-05-31	Big4
DUPIXENT 200MG/1.14ML,PEN 2PK	Sanofi Aventis U.S. LLC	00024-5919-02	2x1.14ML	3488.75		2023-06-01 - 2028-05-31	FSS
DUPIXENT 200MG/1.14ML,PEN 2PK	Sanofi Aventis U.S. LLC	00024-5919-02	2x1.14ML	2532.01		2024-01-01 - 2028-05-31	Big4
DUPIXENT 200MG/1.14ML,PEN 2PK	Sanofi Aventis U.S. LLC	00024-5919-02	2x1.14ML	3488.75		2024-01-01 - 2028-05-31	FSS

Zohydro ER Market Analysis and Price Projections

Last updated: February 18, 2026

Zohydro ER (hydrocodone bitartrate extended-release capsules) is an opioid analgesic indicated for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment. Its extended-release formulation allows for less frequent dosing compared to immediate-release opioids. The market for Zohydro ER is primarily driven by the prevalence of chronic pain conditions and the availability of alternative pain management therapies, including non-opioid analgesics, other ER opioids, and interventional procedures.

What is the Current Market Size and Growth Trajectory for Zohydro ER?

The market size for Zohydro ER is intrinsically linked to the broader market for extended-release opioid analgesics and the overall pain management sector. Precise, publicly available market share data specifically for Zohydro ER is limited. However, the U.S. market for opioid analgesics, which includes extended-release formulations, is substantial. In 2022, the global pain management market was valued at approximately $80.5 billion and is projected to grow to $134.8 billion by 2029, at a compound annual growth rate (CAGR) of 7.6% [1]. While Zohydro ER represents a segment of this, its specific market penetration is influenced by prescribing patterns, formulary restrictions, and physician preference.

The growth trajectory for Zohydro ER is subject to several factors:

• Chronic Pain Prevalence: The increasing incidence of chronic pain conditions, such as lower back pain, arthritis, and neuropathic pain, fuels demand for analgesics.
• Competition: Zohydro ER faces competition from other extended-release opioid formulations, including OxyContin (oxycodone controlled-release), Opana ER (oxymorphone extended-release – though its market presence has significantly diminished due to safety concerns and voluntary withdrawal), and generic extended-release hydrocodone products. It also competes with non-opioid pain relievers and alternative therapies.
• Regulatory Environment: The opioid crisis has led to increased regulatory scrutiny and prescribing guidelines for all opioid analgesics, impacting Zohydro ER's market access and physician prescribing habits. This includes state and federal initiatives aimed at reducing opioid use and abuse.
• Physician and Patient Acceptance: The initial introduction of Zohydro ER faced some resistance due to concerns about its abuse potential, as it is not formulated with abuse-deterrent technologies. While newer formulations and risk evaluation and mitigation strategies (REMS) have been implemented, historical perceptions can linger.
• Formulary Access: Insurance provider formularies play a crucial role in Zohydro ER's market penetration. Preferred status on formularies can significantly boost prescriptions, while restrictions or high co-pays can limit access.

Given these dynamics, a precise market size and growth forecast specifically for Zohydro ER is challenging to isolate. However, its performance is expected to align with the broader trends in the ER opioid market, which, despite overall declines in opioid prescribing, still represents a significant therapeutic area for severe chronic pain.

What Are the Key Competitive Products and Their Market Positions?

Zohydro ER competes in a crowded pain management market, with its primary competitive set being other extended-release opioid analgesics. Key competitors include:

• OxyContin (oxycodone controlled-release): Manufactured by Purdue Pharma. OxyContin has historically been a dominant player in the ER opioid market. Despite ongoing legal challenges and evolving market dynamics related to the opioid crisis, it remains a significant competitor. Its market position has been impacted by the emergence of abuse-deterrent formulations and increased regulatory pressure on Purdue Pharma.
• Xtampza ER (oxycodone extended-release capsules): Manufactured by Premier Research. Xtampza ER utilizes proprietary abuse-deterrent technology designed to resist crushing, chewing, and dissolving. This provides a competitive advantage in the current regulatory climate.
• Generic Extended-Release Hydrocodone Products: The availability of generic versions of other extended-release hydrocodone formulations (e.g., Hysingla ER, which is hydrocodone bitartrate extended-release tablets) can offer a lower-cost alternative, impacting Zohydro ER's market share, particularly among cost-sensitive payers and patients.
• Other Opioid Analgesics: While Zohydro ER is an extended-release formulation, it also indirectly competes with other opioids, including immediate-release formulations and other opioid classes, for patients requiring chronic pain management, depending on the severity and type of pain.
• Non-Opioid Analgesics: The market is increasingly shifting towards non-opioid alternatives due to the risks associated with opioids. This includes acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, antidepressants, and topical treatments. These represent a significant indirect competitive threat.
• Interventional Pain Management: Procedures such as nerve blocks, spinal cord stimulation, and radiofrequency ablation offer non-pharmacological alternatives for chronic pain, diverting patients from opioid therapies.

The market position of Zohydro ER is characterized by its unique formulation as an extended-release hydrocodone product without specific abuse-deterrent technologies that are prevalent in newer entrants or reformulations. Its competitive strength lies in its indication for continuous, around-the-clock pain management and its chemical profile as hydrocodone. However, it faces challenges related to the broader public health concern surrounding opioids and the availability of competitor products with enhanced abuse-deterrent features or lower price points.

What Are the Pricing Dynamics and Reimbursement Landscape for Zohydro ER?

Pricing for Zohydro ER is influenced by several factors, including manufacturing costs, R&D investments, marketing expenses, competitor pricing, and the perceived value in the treatment of chronic pain. As an extended-release opioid, its price is generally higher than immediate-release formulations due to the complexity of its manufacturing and extended therapeutic effect.

Manufacturer's Suggested Retail Price (MSRP) and Actual Selling Prices:

Exact MSRPs can fluctuate and are often subject to discounts and rebates negotiated with payers. For example, as of late 2023/early 2024, the average retail price for a 30-count bottle of Zohydro ER 10 mg capsules could range from approximately $300 to $600, depending on the pharmacy and insurance coverage [2]. This translates to a per-capsule cost of $10-$20. Higher dosages and larger quantities would naturally increase the total cost.

Reimbursement Landscape:

The reimbursement landscape for Zohydro ER is complex and has evolved significantly due to opioid-related policies.

• Formulary Placement: Zohydro ER is included on many commercial insurance formularies, but its tier placement varies. It is often placed on higher tiers, requiring higher co-pays or co-insurance, reflecting the general trend of restricting access to opioids. Some plans may require prior authorization or step-therapy protocols, where patients must try other, often non-opioid, pain medications first.
• Medicare and Medicaid: Reimbursement under Medicare Part D and state Medicaid programs is subject to federal and state regulations. These programs often have strict utilization controls and preferred drug lists that can impact Zohydro ER's accessibility. The Centers for Medicare & Medicaid Services (CMS) guidelines and state-specific Medicaid policies are critical determinants of reimbursement.
• Payer Restrictions: Many payers have implemented stringent opioid prescribing guidelines, limiting the total daily dosage, duration of therapy, and the types of patients for whom opioids are approved. This directly affects Zohydro ER's utilization.
• Abuse-Deterrent Formulations (ADFs): While Zohydro ER is not an ADF, the increased availability and preference for ADFs among some payers and prescribers can indirectly impact Zohydro ER's market share and reimbursement if ADFs are prioritized or mandated.
• Patient Assistance Programs: To mitigate out-of-pocket costs for eligible patients, manufacturers may offer patient assistance programs or co-pay cards. These programs can help improve affordability and adherence but do not alter the underlying pricing or reimbursement structure.

Price Projections:

Future pricing for Zohydro ER is likely to be influenced by the ongoing opioid crisis management strategies and the competitive landscape.

• Downward Pressure: Increased availability of generic alternatives, continued payer pressure to limit opioid utilization, and the development of novel non-opioid pain therapies are likely to exert downward pressure on Zohydro ER's price and volume.
• Stability for Chronic Pain: For appropriately selected patients with severe chronic pain requiring continuous opioid therapy, Zohydro ER will likely maintain a stable, albeit potentially volume-constrained, market. The price for these specific indications may remain relatively firm, reflecting the cost of managing severe, intractable pain.
• Generic Competition: The eventual expiration of key patents could lead to the introduction of generic Zohydro ER, which would significantly drive down prices. However, the patent landscape for Zohydro ER needs careful examination for specific expiry dates.
• Value-Based Pricing: Emerging trends in value-based healthcare might influence pricing discussions, though this is more prevalent for newer therapies with demonstrable outcome improvements.

Overall, while Zohydro ER remains a treatment option for specific chronic pain needs, its pricing and reimbursement are under constant scrutiny, and future price projections are tempered by significant regulatory and competitive headwinds.

What Is the Regulatory and Legal Landscape Impacting Zohydro ER?

The regulatory and legal landscape surrounding Zohydro ER is profoundly shaped by the ongoing opioid crisis and the concerted efforts to curb opioid misuse, abuse, and overdose.

Regulatory Frameworks:

• FDA Oversight: The U.S. Food and Drug Administration (FDA) approves opioid analgesics, including Zohydro ER. Post-market surveillance, REMS programs, and labeling requirements are critical components of FDA oversight. Zohydro ER's original approval in 2013 and subsequent labeling changes have been subject to FDA review. The FDA has also issued guidance on the development of opioid analgesics, including requirements for abuse-deterrent formulations.
• Risk Evaluation and Mitigation Strategies (REMS): While Zohydro ER's initial approval did not mandate a specific abuse-deterrent formulation, REMS are a crucial tool for managing the risks of opioid medications. Healthcare providers prescribing Zohydro ER must adhere to any applicable REMS requirements, which may include education on safe prescribing practices and patient counseling on the risks and benefits of opioid therapy. The FDA has encouraged the development and use of abuse-deterrent formulations, and products that incorporate such technologies may receive preferential consideration in some regulatory contexts.
• State Prescription Drug Monitoring Programs (PDMPs): All states operate PDMPs, which are electronic databases that track controlled substance prescriptions. Prescribers and pharmacists are generally required to check PDMPs before dispensing Zohydro ER to identify potential patients who may be diverting or misusing prescription drugs. This provides a layer of oversight and can inform prescribing decisions.
• DEA Scheduling: Hydrocodone bitartrate, the active ingredient in Zohydro ER, is a Schedule II controlled substance under the U.S. Controlled Substances Act. This classification imposes strict regulations on manufacturing, distribution, prescribing, and dispensing, including prescription limitations and record-keeping requirements.

Legal Challenges and Litigation:

• Opioid Litigation: While Zohydro ER itself has not been the primary focus of the mass tort litigation that has engulfed manufacturers of other opioids like OxyContin, it exists within the broader legal environment shaped by these lawsuits. Manufacturers of all opioid analgesics face the risk of litigation related to allegations of deceptive marketing, contributing to the opioid epidemic, and failure to adequately warn about the risks of addiction and overdose.
• Product Liability Claims: Claims can arise if patients allege harm due to the drug's inherent risks if not appropriately managed, or if there are perceived manufacturing defects or inadequate labeling.
• Marketing and Promotion Scrutiny: Regulatory bodies and legal plaintiffs have scrutinized the marketing and promotional practices of opioid manufacturers, particularly concerning claims about addiction risk and pain management efficacy. Companies are subject to scrutiny for any statements that may downplay risks or overstate benefits.

Impact on Market Access and Prescribing:

The stringent regulatory and legal environment has had a profound impact:

• Reduced Prescribing: Overall opioid prescribing has declined significantly over the past decade due to these pressures. This trend affects all opioid products, including Zohydro ER.
• Shift to Non-Opioids: There is a strong push from regulatory bodies, payers, and patient advocacy groups to prioritize non-opioid pain management alternatives whenever possible.
• Increased Scrutiny on Prescribers: Physicians face increased professional and legal risks associated with prescribing opioids, leading to more cautious prescribing habits.
• Focus on Abuse-Deterrent Technologies: Regulatory agencies and some payers increasingly favor opioid products formulated with abuse-deterrent technologies, which can disadvantage Zohydro ER if not reformulated.

The future regulatory and legal landscape for Zohydro ER will likely continue to emphasize harm reduction, prescription controls, and the promotion of safer pain management alternatives. Manufacturers must navigate these evolving complexities to ensure market access and responsible product stewardship.

Key Takeaways

• Zohydro ER operates within a substantial but complex pain management market, influenced by the increasing prevalence of chronic pain and a strong shift towards non-opioid therapies.
• Competition is intense, primarily from other extended-release opioids like OxyContin and Xtampza ER, as well as a growing array of non-opioid analgesics and interventional treatments.
• Pricing is subject to payer negotiations, formulary restrictions, and the need to mitigate high out-of-pocket costs for patients. Projections indicate potential downward price pressure due to generics and market trends, though stable pricing for appropriately selected chronic pain patients is anticipated.
• The regulatory and legal environment is dominated by the opioid crisis, leading to strict prescribing guidelines, PDMP monitoring, and a preference for abuse-deterrent formulations, all of which significantly shape Zohydro ER's market access and prescribing patterns.

Frequently Asked Questions

1. What are the specific patent expiry dates for Zohydro ER that would allow for generic entry? Specific patent expiry dates for Zohydro ER require detailed patent landscaping analysis. The primary patent is U.S. Patent No. 7,879,376, which has an expiry date in late 2025. However, other patents related to its formulation, manufacturing processes, and methods of use could extend market exclusivity. Generic manufacturers will assess these patents for potential challenges or expiry timelines.

2. How does the abuse potential of Zohydro ER compare to immediate-release hydrocodone products and other ER opioids? Zohydro ER is an extended-release formulation of hydrocodone bitartrate. Like all opioid analgesics, it carries a risk of abuse, dependence, and addiction. Its extended-release nature is designed to reduce the euphoria associated with rapid dose absorption, thus theoretically lowering abuse potential compared to immediate-release formulations when used as prescribed. However, it does not incorporate specific abuse-deterrent technologies designed to resist crushing, chewing, or dissolving, which are features of some newer ER opioid formulations.

3. What is the typical daily dosage range for Zohydro ER in clinical practice? The starting dosage for Zohydro ER is typically 10 mg every 12 hours. Dosage adjustments are based on individual patient response, pain severity, and tolerance. Doses can be increased by 5 mg to 10 mg every 3 days as needed. The maximum daily dose is not explicitly defined in the prescribing information, but doses are titrated to achieve adequate pain relief with acceptable side effects. Clinicians generally aim for the lowest effective dose.

4. Are there any specific risk management strategies mandated by the FDA for Zohydro ER beyond standard controlled substance regulations? As of its last major regulatory reviews, Zohydro ER did not have a mandatory, product-specific REMS program that included requirements for abuse-deterrent formulations at the time of its initial approval. However, all opioid analgesics are subject to the general opioid REMS program that focuses on prescriber and dispenser education. Manufacturers are also encouraged to develop and implement strategies to mitigate abuse and diversion.

5. How has the market share of Zohydro ER been affected by the increasing use of medical cannabis for chronic pain management? The increasing use of medical cannabis for chronic pain management represents a competitive threat to all opioid analgesics, including Zohydro ER. As more patients and physicians turn to cannabis as an alternative or adjunct therapy, it can lead to a reduction in opioid prescriptions for chronic pain. The extent of this impact on Zohydro ER specifically is difficult to quantify without detailed market data, but it contributes to the broader trend of diversifying pain management strategies away from opioids.

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Citations

[1] Grand View Research. (2023). Pain Management Market Size, Share & Trends Analysis Report By Type (Analgesics, Interventional Procedures), By Application (Neuropathic Pain, Chronic Back Pain), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Grand View Research website]

[2] GoodRx. (2023). Zohydro ER Prices, Coupons, and Patient Assistance Programs. Retrieved from [GoodRx website]