DILAUDID Drug Patent Profile

Which patents cover Dilaudid, and what generic alternatives are available?

Dilaudid is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilaudid

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

Summary for DILAUDID

International Patents:	22
US Patents:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	103
Patent Applications:	4,649
Drug Prices:	Drug price information for DILAUDID
Drug Sales Revenues:	Drug sales revenues for DILAUDID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILAUDID
What excipients (inactive ingredients) are in DILAUDID?	DILAUDID excipients list
DailyMed Link:	DILAUDID at DailyMed

See drug prices for DILAUDID

See drug sales revenues for DILAUDID

Recent Clinical Trials for DILAUDID

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 clinical trials

Pharmacology for DILAUDID

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for DILAUDID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DILAUDID	Tablets	hydromorphone hydrochloride	2 mg, 4 mg, and 8 mg	019892	1	2013-08-05
DILAUDID	Oral Solution	hydromorphone hydrochloride	5 mg/5mL	019891	1	2011-02-25

US Patents and Regulatory Information for DILAUDID

DILAUDID 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	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-006	Jan 16, 2020	AP	RX	Yes	Yes	9,248,229		Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No	9,731,082		Y
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	AP	RX	Yes	Yes	9,248,229		Y
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-007	Feb 10, 2017	AP	RX	Yes	Yes	9,731,082		Y
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-003	Nov 9, 2007	AB	RX	Yes	No
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	AP	RX	Yes	Yes	9,731,082		Y

Expired US Patents for DILAUDID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	SOLUTION;ORAL	019891-001	Dec 7, 1992	6,589,960
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	6,589,960
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-003	Nov 9, 2007	6,589,960
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-002	Nov 9, 2007	6,589,960
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-001	Dec 7, 1992	6,589,960
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009	6,589,960

International Patents for DILAUDID

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

Country	Patent Number	Title	Estimated Expiration
Spain	2359657
Denmark	2968729
Japan	2012510330
Austria	402937
Japan	5737692
Australia	2018236914	PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS

Market Dynamics and Financial Trajectory for DILAUDID (Hydromorphone)

Last updated: July 28, 2025

Introduction

DILAUDID (hydromorphone hydrochloride) is an opioid analgesic primarily used for managing moderate to severe pain. As a potent narcotic, it holds a critical position within the analgesic class, balancing efficacy with regulatory scrutiny. Understanding the market dynamics and financial trajectory of DILAUDID involves analyzing factors such as regulatory landscape, prescribing trends, market competition, and the broader opioid crisis impact.

Market Overview

DILAUDID’s market derives from its clinical efficacy and position as a second-line opioid analgesic. It is often prescribed when other opioids fail to provide adequate pain relief or are contraindicated. The global opioid analgesic market was valued at approximately $9.7 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 4.7% through 2028 (1). DILAUDID's unique market segment is influenced heavily by regional healthcare policies, opioid prescribing regulations, and supply chain dynamics.

Regulatory Environment

Regulatory frameworks significantly influence DILAUDID's market trajectory. In major markets like the U.S., the Drug Enforcement Administration (DEA) classifies hydromorphone as a Schedule II substance, indicating strict controls due to potential abuse and addiction. Recent policy initiatives aim to reduce opioid misuse, impacting prescription volumes.

Impact of US Regulations

The U.S. accounts for a significant share of planned prescriptions, yet recent measures—such as dosage limits, prescription monitoring programs (PDMPs), and enhanced provider training—have tempered growth. For instance, in Q1 2022, opioid prescriptions decreased by approximately 15% compared to the previous year (2). This regulatory tightening constrains revenue streams but aims to curb overdose deaths.

Global Regulatory Trends

Outside the U.S., regions like Europe and parts of Asia display varied regulation levels. Some countries pursue stricter controls aligned with international efforts by WHO and UNODC (3). These policies directly influence DILAUDID’s approval, availability, and sales performance globally.

Prescribing Trends and Clinical Use

Despite regulatory barriers, the clinical need for potent opioids persists, especially in palliative care, surgery, and cancer pain management. The World Health Organization (WHO) emphasizes balanced access to opioid analgesics, positioning drugs like DILAUDID as essential medicines.

Hospital vs. Outpatient Settings

Hospital utilization remains dominant, with DILAUDID often administered via injection or continuous infusion for acute pain. Outpatient prescriptions are more limited due to abuse concerns. However, advancements in pain management protocols, including multimodal approaches, may influence future prescribing patterns.

Impact of the Opioid Crisis

The U.S. opioid epidemic initially propelled increased prescribing but has since prompted significant contraction. A 2021 report indicated that prescription volumes decreased by nearly 30% since 2011 (4). Conversely, illicit opioid consumption (fentanyl, heroin) continues to rise, impacting the market landscape and shifting focus toward regulation and harm reduction.

Market Competition

DILAUDID’s primary competitors include other opioids such as morphine, oxycodone, fentanyl, and methadone. The competitive landscape is shaped by factors like efficacy, side effect profile, abuse potential, and regulatory restrictions.

Generic Market Penetration

Post-patent expiration, a surge in generic hydromorphone products has increased market accessibility and pressured pricing. Generics now constitute over 85% of prescriptions (5), compressing margins for branded DILAUDID formulations.

Emerging Alternatives

Non-opioid analgesics and novel modalities—such as kappa-opioid receptor antagonists and peripheral nerve blocks—are in development, potentially reducing reliance on traditional opioids like DILAUDID. Nevertheless, in severe pain management, opioids maintain a vital role due to their rapid and reliable efficacy.

Financial Trajectory and Revenue Projections

Pharmaceutical companies' revenues from DILAUDID depend on market share retention, pricing strategies, and regulatory compliance costs. The trend toward decreasing prescriptions—especially in the U.S.—poses challenges for revenue growth.

Recent Financial Performance

The flagship formulations' sales have plateaued or declined marginally, attributed to tighter prescribing and increased competition from generics. For instance, sales of branded DILAUDID products declined by approximately 12% in the past fiscal year.

Forecasting Future Revenue

Assuming continued regulatory pressures and market consolidation, the global market for hydromorphone-related products may experience a CAGR of 1-2% over the next five years, primarily driven by developing regions with less restrictive policies. In contrast, the U.S. market may see a plateau or marginal decline.

Impact of Supply Chain and Cost Dynamics

Manufacturing costs, especially for branded formulations, remain stable but could fluctuate with raw material prices. Additionally, efforts to curtail misuse may impose additional distribution and monitoring costs, influencing overall profitability.

Future Outlook and Opportunities

Despite challenges, DILAUDID retains niche value in acute care, cancer pain, and palliative settings. Its role may evolve with developments in pain management, regulatory adjustments, and innovative delivery systems like implantable pumps or abuse-deterrent formulations.

Additionally, governments' emphasis on opioid stewardship could lead to incentivizing alternative therapies, impacting long-term growth. Conversely, increasing global access to essential medicines may open new markets, especially in underserved developing countries.

Conclusion

DILAUDID's market depends on a complex interplay of clinical necessity, regulatory environment, and societal response to opioid misuse. While growth might be constrained in regions with stringent controls, continuous medical need and emerging markets offer opportunities. Financial trajectories are expected to be modest, emphasizing the importance of strategic positioning, cost management, and innovation.

---

Key Takeaways

• Regulatory restrictions, especially in the U.S., are primary drivers constraining DILAUDID’s market expansion.
• Generic penetration has increased affordability but compressed profit margins for branded formulations.
• The opioid crisis fundamentally reshaped prescribing trends, leading to a decline in volume, but unmet clinical need sustains demand in specific care settings.
• Global markets, especially in Asia and Africa, present growth opportunities due to improving healthcare infrastructure and access.
• Innovation in delivery systems and abuse-deterrent formulations could influence future market dynamics and financial outcomes.

---

FAQs

1. How does regulatory policy impact DILAUDID’s market share?

Stringent regulations, including prescription monitoring and scheduling laws, limit prescribing volumes, reducing market share. Conversely, relaxed policies or new indications might expand access but are rare due to abuse concerns.

2. What are the main competitors to DILAUDID in the opioid analgesic market?

Key competitors include morphine, oxycodone, fentanyl, and methadone. Generic hydromorphone products also compete on price and accessibility.

3. Are there ongoing developments that could change DILAUDID’s market trajectory?

Yes, innovations such as abuse-deterrent formulations, new delivery methods, and shifting to multimodal pain management could alter demand dynamics.

4. Is DILAUDID still a profitable product for pharmaceutical companies?

Profitability has declined due to market saturation with generics and regulatory pressures, but niche clinical applications sustain some revenue.

5. What are potential markets for growth outside the U.S.?

Emerging markets in Asia, Africa, and Latin America represent opportunities due to increasing healthcare infrastructure and demand for effective pain management solutions.

---

References

1. Grand View Research. Opioid Analgesics Market Size & Share Report, 2021-2028.
2. CDC. Opioid Prescribing Data & Trends, 2022.
3. WHO. Access to Essential Medicines: Strengthening Regulations.
4. IMS Health. U.S. Prescription Opioid Trends, 2021.
5. IQVIA. Generic Drug Market Analysis, 2022.