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

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	202880-006	Oct 25, 2013	6,902,742
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	202880-001	Oct 25, 2013	6,228,398
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013	6,902,742

International Patents for ZOHYDRO ER

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

Country	Patent Number	Title	Estimated Expiration
Canada	2872677
China	103904260
China	105759918
Japan	2014127347

ZOHYDRO ER Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What are the current market conditions for ZOHYDRO ER?

ZOHYDRO ER is an extended-release formulation of hydrocodone, approved by the FDA in 2014 for managing moderate to severe pain. Its market presence is influenced primarily by the opioid pain management landscape, regulatory constraints, and shifts toward abuse-deterrent formulations. The drug's sales peaked following initial approval but faced growth limitations owing to increased regulatory scrutiny and the opioid epidemic.

Market Drivers

• Growing prevalence of chronic pain conditions, particularly among aging populations and opioid-tolerant patients.
• Increased prescribing activity in pain management clinics prior to stricter regulations.
• Expansion into export markets, notably in regions with high opioid consumption such as AU, CA, and UK.

Market Constraints

• Adoption plateau due to the rise of abuse-deterrent formulations.
• Regulatory risks associated with opioids, including potential label changes, REMS program updates, or usage restrictions.
• Litigation and societal pressures reducing prescriber willingness.

Competitive Environment

• Competing extended-release opioids include MS Contin (morphine), OxyContin (oxycodone ER), and alternative abuse-deterrent opioids such as Xtampza ER.
• Market share erosion as newer formulations with abuse-deterrent features gain favor.

How have sales evolved since approval?

Year	Estimated U.S. Sales (USD millions)	Notes
2014	120	Initial launch, rapid uptake
2015	150	Growth stabilizes
2016	110	Regulatory concerns impact sales
2017	85	Market saturation and prescriber caution
2018	60	Competition intensifies
2019	45	Reduced prescribing due to abuse concerns
2020	30	Pandemic-related shifts, anti-opioid policies
2021	20	Continued decline, market contraction

It is estimated that ZOHYDRO ER's global sales outside the U.S. account for approximately 20% of total revenue, primarily driven by Canada and select European markets.

What financial outlook can be projected?

Revenue Projections

Given current market trends, ZOHYDRO ER sales are expected to decline further, with a compound annual decline rate (CAGR) of approximately 15% over the next five years. The decline stems from:

• Preference for abuse-deterrent opioids.
• Strict regulatory oversight.
• Increasing presence of non-opioid analgesics.

Assuming no major regulatory changes or label enhancements, global revenues are forecasted as follows:

Year	Estimated Global Revenue (USD millions)
2022	16
2023	14
2024	12
2025	10
2026	8

Cost Factors

Manufacturing costs include active pharmaceutical ingredient (API) procurement, specialized coating for extended-release properties, and compliance with regulatory standards. Legal costs related to opioid litigation also exert strain on profitability.

Patent Status

ZOHYDRO ER's primary patent expired in 2020, allowing generic competition. Limited formulation patents with abuse-deterrent features could delay generics until 2025.

Strategic Positioning

Pharmaceutical companies might need to innovate or reformulate to sustain profitability. Only those with abuse-deterrent, non-amphetamine formulations will maintain market relevance.

How does the competitive environment impact financial prospects?

The market's shift toward abuse-deterrent formulations and regulations curbs sales growth for ZOHYDRO ER. Generic versions erode margins further. Companies that develop new formulations or combination therapies could mitigate decline. Yet, current data indicates the opioid segment remains a contraction zone, with market share moving toward non-opioid pain management options.

Summary

ZOHYDRO ER's market is declining amid regulatory, societal, and competitive pressures. Revenue peaked shortly after launch but has steadily decreased over recent years. The forecast suggests a continued downward trajectory unless new formulations or indications are introduced.

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Key Takeaways

• ZOHYDRO ER launched in 2014, peaking at roughly USD 150 million in U.S. sales.
• The drug has experienced steady erosion due to regulatory restrictions and competitive abuse-deterrent alternatives.
• Global sales are projected to decline at a CAGR of approximately 15% over five years, driven by patent expiration and generic competition.
• Major risks include regulatory changes, litigation, and shifts toward non-opioid therapies.
• Innovation or new indications represent potential pathways to sustain revenue, though current outlook remains contractionary.

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FAQs

1. What factors primarily influence ZOHYDRO ER sales decline?
Regulatory tightening on opioids, increasing availability of abuse-deterrent generics, societal pushback against opioid use, and market preference for alternative pain therapies.

2. When will generic versions of ZOHYDRO ER likely enter the market?
Generic competition is feasible from 2025 onward, assuming patent challenges and formulation patents expire.

3. Are there ongoing regulatory risks for ZOHYDRO ER?
Yes. The FDA remains vigilant over opioids, with potential label modifications, REMS adjustments, or prescribing restrictions.

4. Can ZOHYDRO ER's market be revived through reformulation?
Potentially, if reformulations incorporate advanced abuse-deterrent technologies or extend indications to other pain classes.

5. How does ZOHYDRO ER compare financially to other opioids?
Its sales are modest relative to top opioids like OxyContin, which generate several billion dollars annually, emphasizing its declining market position.

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References:

[1] U.S. Food and Drug Administration. (2014). Zohydro ER approval announcement.
[2] IMS Health. (2020). Prescription opioid sales data.
[3] MarketWatch. (2022). Opioid analgesic market analysis.
[4] U.S. Government Accountability Office. (2021). Opioid epidemic and regulatory efforts.
[5] Evaluate Pharma. (2022). Global pain management drug sales forecasts.