ZOHYDRO ER Drug Patent Profile

When do Zohydro Er patents expire, and when can generic versions of Zohydro Er launch?

Zohydro Er is a drug marketed by Recro Gainesville and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in twenty-four countries.

The generic ingredient in ZOHYDRO 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 Zohydro Er

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

Summary for ZOHYDRO ER

International Patents:	37
US Patents:	16
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	10
Drug Prices:	Drug price information for ZOHYDRO ER
Drug Sales Revenues:	Drug sales revenues for ZOHYDRO ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOHYDRO ER
What excipients (inactive ingredients) are in ZOHYDRO ER?	ZOHYDRO ER excipients list
DailyMed Link:	ZOHYDRO ER at DailyMed

See drug prices for ZOHYDRO ER

See drug sales revenues for ZOHYDRO ER

Paragraph IV (Patent) Challenges for ZOHYDRO ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOHYDRO ER	Extended-release Capsules	hydrocodone bitartrate	10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg	202880	1	2014-02-26

US Patents and Regulatory Information for ZOHYDRO ER

ZOHYDRO ER is protected by sixteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No	9,610,286
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	9,713,611		Y
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	10,322,120		Y
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No	10,092,559
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No	9,326,982
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No	10,722,511
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	10,722,511

Expired US Patents for ZOHYDRO ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013	6,228,398
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013	6,902,742
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013	6,228,398
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013	6,228,398
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013	6,902,742
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013	6,902,742
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013	6,228,398

International Patents for ZOHYDRO ER

See the table below for patents covering ZOHYDRO ER around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2017112301	СТОЙКИЕ К ЗЛОУПОТРЕБЛЕНИЮ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Russian Federation	2017112301
China	101242813
Mexico	380566
China	1335768
Mexico	2007016151	COMPOSICIONES DE LIBERACION CONTROLADA Y EN FORMA DE NANO-PARTICULAS QUE COMPRENDEN COMPUESTOS ARIL-HETEROCICLICOS. (NANOPARTICULATE AND CONTROLLED RELEASE COMPOSITIONS COMPRISING ARYL-HETEROCYCLIC COMPOUNDS.)
Spain	2313797

Market Dynamics and Financial Trajectory for ZOHYDRO ER

Last updated: August 2, 2025

Introduction

ZOHYDRO ER, an extended-release formulation of hydrocodone, is a prescription opioid used primarily for managing severe pain. As a Schedule II controlled substance, it falls within a complex regulatory and commercial landscape shaped by evolving healthcare policies, societal attitudes toward opioids, and marked shifts in pharmaceutical innovation. This article systematically analyzes the market dynamics and financial trajectory of ZOHYDRO ER, providing insights valuable for investors, pharmaceutical companies, healthcare providers, and policymakers.

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Regulatory Environment and Market Entry Barriers

The landscape for opioid medications like ZOHYDRO ER is heavily influenced by stringent regulatory frameworks. The U.S. Food and Drug Administration (FDA) rigorously monitors opioid formulations due to their potential for misuse, dependence, and diversion. In 2020, the FDA issued new guidelines urging manufacturers to develop abuse-deterrent formulations (ADFs) in response to the opioid crisis, impacting product development and market acceptance.

Additionally, the Drug Enforcement Agency (DEA) has tightened restrictions on prescribing and dispensing opioids, further constraining market growth. Generic competition has also increased since patent expirations, fragmenting market share among multiple players. Notably, while the original patent for ZOHYDRO ER has expired or is nearing expiry, manufacturers have sought to introduce reformulated versions with enhanced abuse-deterrent qualities, influencing market dynamics.

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Market Size and Growth Drivers

The global opioid analgesics market was valued at approximately USD 13 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of about 4% through 2028 ([1], Grand View Research). Despite regulatory and societal challenges, the demand for potent, long-acting pain relief remains robust due to an aging population, rising prevalence of chronic pain conditions, and improving pain management protocols.

In the United States, opioids constitute a significant portion of pain management therapies. The CDC reported that over 50 million Americans experience chronic pain, underpinning the enduring need for effective opioid formulations like ZOHYDRO ER. The growing opioid prescribing trends, coupled with the adoption of pain management guidelines favoring long-acting opioids for severe, persistent pain, bolster ZOHYDRO ER's market potential.

However, the ongoing opioid epidemic has prompted increased scrutiny and regulatory restrictions, tempering growth forecasts. These dynamics necessitate a careful balancing act between addressing unmet medical needs and mitigating abuse risks.

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Competitive Landscape

Key competitors include other extended-release opioids such as OxyContin (oxycodone ER), MS Contin (morphine ER), and newer abuse-deterrent formulations like Xtampza ER. The emergence of abuse-deterrent formulations has shifted market share, emphasizing safety and misuse reduction. For instance, Purdue Pharma’s reformulated OxyContin gained FDA approval in 2010 with abuse-deterrent features, influencing market expectations for similar products like ZOHYDRO ER.

The entry of generics post-patent expiry further fragments the market, reducing revenues for the original manufacturer. Companies that successfully develop more effective abuse-deterrent formulations or possess patents covering innovative delivery systems can sustain higher margins and market share.

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Regulatory and Societal Influences on Financial Trajectory

The financial outlook hinges on regulatory trajectories, societal perceptions, and legislative actions. The Biden administration and Congress have unveiled measures aimed at curbing opioid misuse, including tighter prescribing guidelines and increased funding for addiction treatment programs. These initiatives, while crucial for public health, pose risks for sales volumes of opioid medications like ZOHYDRO ER ([2]).

In parallel, legal pressures from class-action lawsuits against opioid manufacturers—claiming deceptive marketing practices and contributing to the opioid crisis—may impact profitability and market viability. The resolution of ongoing legal disputes and potential settlement costs could influence cash flows and corporate valuation.

Adjustments in reimbursement policies by insurance providers and Medicaid/Medicare also affect market access and pricing strategies. The adoption of value-based pricing models, emphasizing safety and long-term cost savings via abuse deterrence, might bolster ZOHYDRO ER’s financial prospects if it demonstrates a superior risk profile.

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Innovations and Asset Development

The development of abuse-deterrent formulations (ADFs) has become central to ZOHYDRO ER’s future. Capable of reducing misuse via tamper-resistant features, ADFs align with regulatory mandates and societal expectations. Innovating within this space can enable companies to maintain premium pricing and market relevance despite generic competition.

Additionally, digital health integration—such as biometric monitoring and prescription drug monitoring programs (PDMPs)—is gaining traction, promising to enhance responsible prescribing and consumption. Pharmaceutical companies investing in such innovations could bolster the profile and therapeutic value of ZOHYDRO ER, positively affecting revenue streams.

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Financial Trajectory and Investment Outlook

Forecasts suggest that ZOHYDRO ER’s revenues will face headwinds but remain resilient within its niche, especially if reformulated with advanced abuse-deterrence features. The patent landscape and regulatory developments are critical determinants; patent expiries could lead to revenue erosion, whereas new formulations could rejuvenate sales.

The company's strategic focus on research and development (R&D), clinical evidence supporting safety and efficacy, and strong regulatory compliance are central to sustaining financial success. Conversely, increased scrutiny, legal liability, and societal pushback could cap growth prospects.

In an environment of cautious optimism, companies that effectively innovate, demonstrate safety, and align with legal frameworks may see modest, sustained revenue streams. Conversely, declining formulations without new patent protection or meaningful abuse-deterrent features could witness revenue diminutions over a 3-5 year horizon.

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Market Trends and Future Outlook

The transition toward multimodal pain management, integrating non-opioid therapies and advanced formulations, poses both risks and opportunities. Companies investing in combination therapies or alternative modalities could encroach on traditional opioid markets, impacting ZOHYDRO ER's long-term viability.

Emerging digital and personalized medicine approaches could redefine pain management, possibly diminishing reliance on opioids. However, for severe pain cases, long-acting formulations like ZOHYDRO ER remain indispensable, affording a niche for continued revenues if market conditions remain favorable.

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Key Takeaways

• The market for ZOHYDRO ER faces a nuanced landscape shaped by regulatory reforms, societal attitudes, and technological innovations.
• Patent expiration and generic competition threaten revenue streams, emphasizing the importance of abuse-deterrent reformulations and patent strategies.
• Societal pushback against opioids and legislative measures are likely to temper growth but can be mitigated through improved safety profiles and value-based pricing.
• Asset innovation, including abuse-deterrent formulations and digital health integrations, will be pivotal for sustaining financial health.
• The future of ZOHYDRO ER hinges on balancing regulatory compliance, technological advancement, and societal needs within a shifting healthcare paradigm.

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FAQs

1. How does patent expiration affect ZOHYDRO ER’s market potential?
Patent expiration opens the market to generic competitors, significantly reducing prices and margins. To sustain revenue, companies need to develop reformulations with abuse-deterrent features or acquire new patents.

2. What role do abuse-deterrent formulations play in ZOHYDRO ER’s future?
They are critical for regulatory compliance and market relevance. Abuse-deterrent features can command premium pricing, reduce misuse, and align with legal requirements, thus positively impacting the drug’s financial trajectory.

3. How are regulatory policies influencing the opioid market?
Stricter prescribing guidelines, enhanced monitoring, and legal actions have curtailed sales growth. However, approval of safer formulations with abuse-deterrent properties provides opportunities for continued market presence.

4. What are the main risks to ZOHYDRO ER’s revenue growth?
Legal liabilities, societal backlash, regulatory restrictions, and aggressive competition from generics and alternative therapies threaten revenue stability.

5. Can digital health innovations impact ZOHYDRO ER’s market?
Yes. Digital tools that improve prescribing practices, monitor compliance, and reduce misuse can enhance safety, potentially elevating ZOHYDRO ER’s market profile and patient trust.

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References

[1] Grand View Research. "Opioid Market Size, Share & Trends Analysis Report." 2021.
[2] Centers for Disease Control and Prevention. "Annual Surveillance Report of Drug-Related Risks and Outcomes." 2022.