DILAUDID-HP Drug Patent Profile

When do Dilaudid-hp patents expire, and when can generic versions of Dilaudid-hp launch?

Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are two patents protecting this drug and four Paragraph IV challenges.

This drug has twenty-two patent family members in twelve countries.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilaudid-hp

A generic version of DILAUDID-HP was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

Summary for DILAUDID-HP

International Patents:	22
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	103
Patent Applications:	2,124
DailyMed Link:	DILAUDID-HP at DailyMed

Recent Clinical Trials for DILAUDID-HP

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Keck School of Medicine of USC	PHASE3
University of Miami	Phase 2
The Cleveland Clinic	N/A

See all DILAUDID-HP clinical trials

Pharmacology for DILAUDID-HP

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for DILAUDID-HP

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DILAUDID-HP	Injection	hydromorphone hydrochloride	0.2 mg/mL	019034	1	2023-12-19
DILAUDID-HP	Injection	hydromorphone hydrochloride	0.5 mg/0.5 mL and 1 mg/mL	019034	1	2022-12-13
DILAUDID-HP	Injection	hydromorphone hydrochloride	10 mg/mL	019034	1	2011-11-04
DILAUDID-HP	Injection	hydromorphone hydrochloride	2 mg/mL	019034	1	2011-06-22

US Patents and Regulatory Information for DILAUDID-HP

DILAUDID-HP is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984		DISCN	Yes	No			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984		DISCN	Yes	No			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No			Y

Expired US Patents for DILAUDID-HP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994

International Patents for DILAUDID-HP

See the table below for patents covering DILAUDID-HP around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2376147
China	204798475
Japan	5737692
Japan	2012510330
Canada	2902346	SYSTEME DE CONDITIONNEMENT POUR MEDICAMENTS SENSIBLES A L'OXYGENE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
Australia	1595701

Market Dynamics and Financial Trajectory for DILAUDID-HP

Last updated: July 28, 2025

Introduction

DILAUDID-HP, a high-potency formulation of hydromorphone, operates within a complex pharmaceutical landscape marked by evolving regulatory frameworks, shifting prescriber practices, and dynamic demand patterns. As a potent opioid analgesic, DILAUDID-HP’s market trajectory hinges on its clinical utility, regulatory constraints, societal attitudes towards opioids, and competitive positioning. This analysis aims to provide a comprehensive overview of the key market drivers, financial prospects, and strategic considerations influencing DILAUDID-HP’s future in the pharmaceutical industry.

Pharmacological Profile and Clinical Applications

DILAUDID-HP combines hydromorphone, a potent opioid analgesic, with a high-potency formulation designed for severe pain management, especially in oncology, palliative care, and post-operative settings. Its efficacy in alleviating intense pain offers significant clinical value, often reserved for cases where other analgesics prove inadequate. However, the same potency that underpins its medical utility also predicates concerns regarding abuse potential and regulatory scrutiny.

Regulatory Environment and Impact on Market Dynamics

Stringent Oversight and Restrictions

DILAUDID-HP's registration, distribution, and prescribing are governed by strict regulatory standards primarily overseen by agencies such as the U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA). The opioid epidemic has resulted in tighter controls, with increased licensing, monitoring, and prescribing limitations [1].

Changing Prescription Guidelines

In recent years, health authorities have enacted guidance to curb opioid overprescription, emphasizing multimodal pain management and non-opioid alternatives. This shift impacts volume sales, particularly in regions with aggressive opioid stewardship policies. Conversely, for patients with severe, refractory pain, DILAUDID-HP remains an essential option, preserving its niche but constraining broad market expansion.

Market Drivers

Growing Demand for Pain Management in Specialized Settings

The increase in chronic pain prevalence, especially among aging populations, fuels demand for potent opioids like DILAUDID-HP, primarily within hospices, cancer treatment centers, and postoperative care units [2]. Advances in personalized medicine and improved pain management protocols further enhance its utility.

Regulatory and Legal Challenges

Despite demand, regulatory constraints and opioid litigation risks pose significant barriers. High-profile lawsuits against pharmaceutical companies have led to more cautious prescribing practices and, in some cases, reduced access to opioids, impacting DILAUDID-HP’s sales trajectory.

Market Competition and Alternatives

DILAUDID-HP faces competition from generic hydromorphone formulations, other opioid derivatives, and non-opioid analgesics such as NSAIDs, anticonvulsants, and antidepressants for chronic neuropathic pain [3]. The advent of abuse-deterrent formulations (ADFs) aims to reduce misuse, influencing both market share and pricing strategies.

Emerging Non-Opioid Pain Therapies

Advancements in non-opioid pain therapeutics—such as gabapentinoids, nerve growth factor inhibitors, and novel anti-inflammatory agents—are gradually reshaping the pain management landscape, potentially diminishing the long-term demand for opioid-based products like DILAUDID-HP [4].

Financial Projections

Revenue Streams

The primary revenue source for DILAUDID-HP derives from hospital and institutional sales, with limited retail or outpatient prescriptions due to regulatory constraints. Currently, sales are concentrated in regions with high pain management needs and less restrictive opioid stewardship policies.

Pricing Dynamics and Reimbursement

Premium pricing persists owing to the drug’s potency and formulation complexity. However, reimbursement policies, especially within government-funded healthcare systems, are becoming more stringent, leading to margin pressures. Payer scrutiny regarding opioid utilization and abuse liability exerts additional influence on pricing and formulary placements.

Market Penetration and Growth Outlook

Forecasting indicates modest growth over the next 3-5 years, contingent on:

• Continued clinical necessity in specialized pain management procedures.
• Regulatory stability allowing sustained prescribing.
• Introduction of abuse-deterrent formulations or new delivery systems reducing misuse concerns.

A compound annual growth rate (CAGR) of approximately 2-4% seems attainable, aligning with broader opioid market trends [5]. However, downside risks include stricter laws, societal backlash, and shifting reimbursement policies.

Risks and Considerations

1. Regulatory Risks: Potential for tighter restrictions, scheduling reclassification, or import bans could constrain access.
2. Legal Liabilities: Ongoing litigation and liability exposure may induce operational and financial costs.
3. Market Share Erosion: Efficacy of abuse-deterrent formulations and alternative therapies could curtail demand.
4. Public Perception: Growing societal concern over opioids may influence prescriber behavior and patient acceptance.

Strategic Outlook

To optimize its financial trajectory, stakeholders could consider diversifying formulations, investing in novel delivery systems, and engaging proactively with regulatory agencies. Pharmaceutical innovator alliances focusing on abuse deterrence and targeted niche marketing could also sustain profitability.

Key Takeaways

• DILAUDID-HP remains a critical agent in severe pain management but faces diminishing growth prospects amid regulatory tightening and societal challenges.
• The current market is highly concentrated in institutional settings with constrained outpatient prescriptions.
• Future growth hinges on navigating regulatory changes, embracing abuse-deterrent technologies, and competing with emerging non-opioid therapies.
• Pricing and reimbursement pressures demand strategic cost management and value demonstration.
• Long-term viability depends on balancing clinical utility with societal responsibilities, especially under increasing scrutiny of opioid use.

FAQs

Q1: What factors most significantly influence DILAUDID-HP's market performance?
A1: Regulatory constraints, prescriber habits, societal attitudes towards opioids, competition from alternatives, and advancements in abuse-deterrent technologies primarily impact its performance.

Q2: How does the opioid epidemic affect DILAUDID-HP’s sales prospects?
A2: The epidemic has resulted in stricter regulations, reduced prescribing, and increased legal risks, collectively tempering growth prospects despite ongoing clinical demand.

Q3: Are non-opioid pain therapies a threat to DILAUDID-HP’s market share?
A3: Yes. As non-opioid options improve in efficacy and safety, they pose a competitive threat, particularly for non-severe pain management.

Q4: What regulatory trends could impact DILAUDID-HP in the future?
A4: Potential reclassification under stricter scheduling, mandatory abuse-deterrent formulations, and tighter prescribing guidelines could significantly influence its market access.

Q5: What strategic moves can pharmaceutical companies pursue to sustain DILAUDID-HP’s relevance?
A5: Investing in abuse-deterrent formulations, expanding niche clinical applications, engaging with regulators, and diversifying pain management portfolios are vital strategies.

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Sources:

[1] U.S. Food & Drug Administration. (2022). "Opioid Analgesics."
[2] National Cancer Institute. (2021). "Pain Management in Cancer Patients."
[3] IMS Health. (2022). "Opioid Market Overview."
[4] Journal of Pain Research. (2020). "Emerging Non-Opioid Analgesics."
[5] MarketWatch. (2023). "Pharmaceutical Market Forecasts."