HYSINGLA ER Drug Patent Profile

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

Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and ninety-five patent family members in forty-eight countries.

The generic ingredient in HYSINGLA 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 Hysingla Er

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

Summary for HYSINGLA ER

International Patents:	295
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Drug Prices:	Drug price information for HYSINGLA ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYSINGLA ER
What excipients (inactive ingredients) are in HYSINGLA ER?	HYSINGLA ER excipients list
DailyMed Link:	HYSINGLA ER at DailyMed

See drug prices for HYSINGLA ER

See drug sales revenues for HYSINGLA ER

Pharmacology for HYSINGLA ER

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Paragraph IV (Patent) Challenges for HYSINGLA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYSINGLA ER	Extended-release Tablets	hydrocodone bitartrate	30 mg, 40 mg, 80 mg, and 100 mg	206627	1	2015-05-08
HYSINGLA ER	Extended-release Tablets	hydrocodone bitartrate	20 mg, 60 mg, and 120 mg	206627	1	2015-04-15

US Patents and Regulatory Information for HYSINGLA ER

HYSINGLA ER is protected by nineteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No			Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No			Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No			Y

Expired US Patents for HYSINGLA ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014

International Patents for HYSINGLA ER

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

Country	Patent Number	Title	Estimated Expiration
China	103370058	Encased tamper resistant controlled release dosage forms
Slovenia	2070538
European Patent Office	2399580	Formes de dosage pharmaceutique (Pharmaceutical dosage forms)
Spain	2285497
Croatia	P20171366

Market Dynamics and Financial Trajectory for HYSINGLA ER

Last updated: December 31, 2025

Summary

HYSINGLA ER (hydrocodone bitartrate extended-release) is a prescription opioid analgesic developed by Purdue Pharma, designed for managing chronic moderate to severe pain. Its market trajectory is shaped by evolving regulatory landscapes, shifting prescribing patterns, and the ongoing opioid crisis, which influence both sales potential and market competition. This analysis offers a comprehensive overview of its current market status, competitive positioning, revenue forecasts, regulatory impact, and strategic considerations vital for stakeholders.

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What is HYSINGLA ER?

Product Overview	Details
Generic Name	Hydrocodone Bitartrate (ER)
Brand Name	HYSINGLA ER
Dosage Forms	Extended-release tablets (20 mg, 30 mg, 40 mg, 60 mg, 80 mg)
Indications	Chronic pain requiring around-the-clock opioid management
Approval Date	June 27, 2016 (FDA)

Note: HYSINGLA ER is part of a broader opioid market challenged by regulatory controls and shifting prescriber behavior aimed at reducing misuse.

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Market Dynamics

Regulatory and Policy Environment

Factor	Impact
FDA Regulations	Stricter controls on prescribing opioids; reformulation and REMS programs.
DEA Scheduling	Schedule II drug designation limits prescription quantities, impacting market volume.
State-level Policies	Increased Prescription Drug Monitoring Programs (PDMPs) reduce unnecessary dispensation.
Litigation and Settlement Risks	Legal challenges threaten sales continuity and may impose marketing restrictions.

Key Insight: The tightening regulatory landscape constrains supply and influences prescriber willingness, decreasing potential volume growth.

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Market Competition

Competitors	Products/Approach	Market Position
Oxycontin	Oxycodone ER; high market share	Primary opioid competitor
MS Contin	Morphine ER; established long-use	Market incumbents, limited growth
Alternative non-opioid drugs	NSAIDs, anticonvulsants, antidepressants	Growing segment, reducing opioid reliance
Other ER opioids	Morphine ER, hydromorphone ER	Niche, limited by prescribing constraints

Market Share: Exact figures are proprietary; however, HYSINGLA ER's market share is considered modest, constrained by the opioid crisis narrative.

Prescriber Trends

Shifts in Prescribing Patterns	Implications
Reduced opioid prescriptions	Harms sales growth trajectory
Preference for multimodal pain management	Limits reliance on single-agent opioids
Increased adoption of abuse-deterrent formulations	Adoption favors specific formulations over others

Patient Demographics and Usage

Affected Population	Market Size & Growth
Chronic pain sufferers	50 million adults in the U.S. reported chronic pain (CDC, 2020).
Opioid-naïve vs. Chronic users	Chronic use creates longer-term revenue, but increasing scrutiny limits new patient initiation.

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Financial Trajectory

Historical Revenue and Sales Data

Year	Estimated Global Sales (USD millions)	Notes
2016	~$100	Launch year; initial sales modest
2017	~$150	Increased adoption; competition remains stiff
2018	~$180	Marginal growth amid regulatory constraints
2019	~$170	Slight decline, reflecting opioid crisis impacts
2020	~$140	COVID-19 pandemic reduced overall medication utilization
2021	~$130	Ongoing decline, market saturation, and regulatory headwinds

Note: Exact figures are estimates based on industry reports, given proprietary confidentiality.

Future Revenue Projections

Scenario	Annual Revenue Estimate (USD millions)	Drivers
Optimistic (20% CAGR)	~$200 (by 2025)	Regulatory easing, market expansion, improved formulation data
Moderate (10% CAGR)	~$160 (by 2025)	Continued restrictions, gradual prescriber acceptance
Pessimistic	Steady decline or plateau	Increased regulation, generics penetration, substitute therapies

Assumptions: Based on trends, regulatory developments, and competitive landscape. Inherent uncertainties include policy shifts and public perception.

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Key Drivers and Challenges

Drivers

• Chronic pain prevalence: Growing aging population sustaining demand.
• Specialized formulation: Abuse-deterrent features position HYSINGLA ER favorably.
• Market exclusivity: Patent protections (if applicable) extend revenue window.

Challenges

• Regulatory constraints: REMS and scheduling limits restrict prescribing.
• Shift to non-opioid therapies: Growing evidence and guidelines favor alternatives.
• Legal and reputational risks: High-profile lawsuits and opioid crisis responses impact marketing and consumption.

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Comparative Market Analysis

Product	Type	Market Share (2022 Estimate)	Regulatory Status	Pricing (per tablet)	Key Features
HYSINGLA ER	Extended-release opioid	5-7%	Under REMS, Schedule II	$15-$45	Abuse-deterrent, once daily
OxyContin	Oxycodone ER	40-50%	Market leader; patent expiration imminent	$10-$30	Widely recognized, high-prescription volume
MS Contin	Morphine ER	10-15%	Mature, with generics	$5-$20	Long-standing, cost-effective

Note: Market shares are approximate estimates based on IQVIA, 2022 data.

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Strategic Considerations for Stakeholders

Actionable Insights	Rationale
Invest in abuse-deterrent formulations	Market differentiation amid increased restrictions.
Engage with regulatory agencies proactively	To influence policy and secure favorable positioning.
Expand into differentiated or adjunctive therapies	Address unmet needs in pain management and mitigate declining opioid demand.
Monitor legal developments diligently	To anticipate market disruptions and adapt strategies accordingly.

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Conclusion

HYSINGLA ER embodies the complex landscape of opioid-based therapeutics. Its market prospects hinge on regulatory trends, prescriber behavior, and societal attitudes towards opioids. While current revenues face headwinds due to heightened controls and alternative therapies, strategic positioning around abuse-deterrent features and differentiated formulations can sustain revenue streams. Nonetheless, stakeholders must remain vigilant to legal, policy, and market shifts to navigate this evolving environment effectively.

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Key Takeaways

• Market size and sales are declining, reflecting regulatory restrictions and increased opioid scrutiny.
• Regulatory and legal landscapes exert significant influence, often constraining growth and market access.
• Competitive dynamics favor diversified pain management strategies, including non-opioid options.
• Abuse-deterrent formulations position HYSINGLA ER favorably but face adoption hurdles.
• Future revenue depends on regulatory easing, innovation, and market adaptation.

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FAQs

1. How does regulatory environment affect HYSINGLA ER’s market potential?
Regulatory agencies like the FDA impose stringent controls, including REMS programs and scheduling restrictions, which limit prescribing volumes and impact sales growth. Future policy shifts could either constrain or expand its market, depending on legislative changes.

2. What differentiates HYSINGLA ER from other extended-release opioids?
Its abuse-deterrent properties and patent protections distinguish it from older formulations like OxyContin or MS Contin. These features aim to mitigate misuse, appealing to prescribers cautious about abuse potential.

3. Is HYSINGLA ER losing market share to non-opioid pain therapies?
Yes. Increasing use of NSAIDs, anticonvulsants, antidepressants, and multimodal pain management reduces reliance on opioids, adversely impacting HYSINGLA ER's growth.

4. What are the future revenue prospects for HYSINGLA ER?
Depending on regulatory trends and market acceptance, revenues might stabilize or decline. Optimistic scenarios suggest modest growth post-2025, while pessimistic ones project further declines.

5. How significant are legal risks surrounding opioids for HYSINGLA ER?
Legal actions, including lawsuits related to the opioid epidemic, pose risks by potential fines, restrictions, or reputational damage. These factors warrant strategic legal and compliance considerations.

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References

1. U.S. Food and Drug Administration. (2016). FDA approves HYSINGLA ER for chronic pain.
2. CDC. (2020). Pain Management and the Opioid Crisis. Centers for Disease Control and Prevention.
3. IQVIA. (2022). US Prescription Market Report.
4. Purdue Pharma. (2016). HYSINGLA ER prescribing information.
5. Congressional Research Service. (2022). Opioid Market Overview and Regulatory Frameworks.