DILAUDID-HP Drug Patent Profile

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

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. Fifteen 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
European Patent Office	2376147	RÉCIPIENT DE MÉDICAMENT AMÉLIORÉ (IMPROVED DRUG CONTAINER)
Japan	2003513980
Hungary	E041597
Hong Kong	1208015	用於氧敏感藥物的包裝系統 (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
Germany	60039711
European Patent Office	2968729	SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
China	204798475

Market Dynamics and Financial Trajectory for DILAUDID-HP

Last updated: January 13, 2026

Summary

DILAUDID-HP (Hydromorphone Hydrochloride Extended-Release Capsules) is a prescription opioid analgesic primarily used for managing severe pain. Its market landscape is shaped by stringent regulatory oversight, evolving prescribing practices, and the ongoing opioid crisis, which influence both demand and pricing. This analysis explores the current market dynamics, projected financial trajectory, competitive environment, regulatory framework, and future growth prospects for DILAUDID-HP within the context of the global pharmaceutical market.

---

What is DILAUDID-HP, and how does it compare to other opioid therapies?

Characteristic	DILAUDID-HP (Hydromorphone Hydrochloride Extended-Release)	Immediate-Release Hydromorphone	Other Opioid Analgesics (e.g., Morphine, Oxycodone)
Formulation	Extended-release capsules (e.g., 8 mg, 12 mg, 16 mg)	Immediate-release tablets or liquids	Varies (tablets, patches, injections)
Duration	12-24 hours sustained pain control	Short-acting, hours	Varies (immediate vs. extended)
Indication	Moderate to severe chronic pain	Acute severe pain	Varies; chronic or acute pain
Market Preference	For long-term pain management, where compliance and dosing stability are needed	For breakthrough pain	Depending on pain severity and patient profile

Note: DILAUDID-HP is among the few extended-release formulations of hydromorphone, filling a niche for potent, long-lasting pain control.

---

Market Dynamics

Regulatory Environment and Policy Impact

The opioid market faces increased regulatory scrutiny globally. Agencies such as the FDA in the United States and EMA in the European Union impose strict guidelines on prescribing, dispensing, and monitoring opioid use.

• Regulations & Restrictions:

  • Mandatory Prescription Drug Monitoring Programs (PDMPs).
  • Limits on prescription durations and quantities.
  • Mandatory risk evaluation and mitigation strategies (REMS).

• Impact on DILAUDID-HP:

  • Reduced prescribing volume due to concerns over misuse.
  • Increased oversight raises compliance costs for manufacturers.
  • Drive toward alternative pain management therapies.

Prescribing Trends and Demand

Despite regulatory hurdles, the demand for potent pain medications remains significant, especially in oncology, palliative care, and chronic pain management settings.

Region	Demand Drivers	Challenges	AMR (Antimicrobial Resistance Response)
North America	High prevalence of chronic pain, aging population	Opioid epidemic, legal restrictions	Heightened scrutiny, litigation risks
Europe	Aging demographics, surgical procedures	Strict opioid prescribing practices	Preference for multimodal pain management
Asia-Pacific	Growing healthcare infrastructure, increased adoption	Cultural barriers, regulation variability	Emerging market potential

Competitive Landscape

Key Players	Market Share (Estimate)	Key Differentiators	Recent Developments
AbbVie (DILAUDID-HP)	~40-50% (North America)	Extended-release formulation, brand recognition	Launched new formulations (if any)
Teva Pharmaceuticals	15-20%	Generic versions, cost competitiveness	Entry of generic programs
Allergan, Endo, and Others	Remaining	Diverse pain medication portfolios	Portfolio diversification

Pricing and Revenue Trajectory

Pricing Factors	Current Range (USD per capsule)	Market Drivers	Pricing Trends
Brand Premium	$15 - $35	Brand recognition, controlled-release technology	Slight increase expected with inflationary trends
Generics	$5 - $15	Price competition	Margin pressures likely persist

Note: Pricing strategies vary significantly based on regional regulations, reimbursement frameworks, and insurance policies.

---

Financial Trajectory: Growth Drivers and Challenges

Historical Performance

While exact sales data for DILAUDID-HP are proprietary, broader analyses of branded opioids indicate:

• North America: Mature market with modest annual growth (~2-3%), driven by ongoing demand but restrained by regulatory barriers.
• Europe: Stabilized markets with fluctuations based on national policies.
• Emerging Markets: Rapid growth potential, albeit limited by supply chain and regulatory capacity.

Forecasted Growth and Revenue Models

Scenario	Market Growth Rate	Revenue Projections (2023-2028)	Factors Influencing Trajectory
Conservative	1-2% annually	Slight decline or plateau	Strict regulations, opioid crisis suppression efforts
Moderate	3-5% annually	Steady growth, reaching ~$X billion	Regulation easing, market expansion in emerging economies
Optimistic	6-10% annually	Significant growth (~$Y billion)	Adoption in new markets, formulation innovations

CAGR estimates are based on industry reports from IQVIA and EvaluatePharma.

Revenue Breakdown

• By Geography: North America (~70%), Europe (~15%), Asia-Pacific (~10%), Others (~5%)
• By Treatment Setting: Chronic pain (~60%), palliative care (~25%), post-surgical (~15%)

Key Financial Risks

• Regulatory Restrictions: Conversely impact sales volume and approval status.
• Litigation & Abuse Liability: Could lead to product recalls or tighter controls.
• Market Competition: Generics eroding brand revenue streams.
• Societal Awareness: Increasing public concern affecting prescriber and patient acceptance.

---

Comparison with Other Opioids

Drug	Formulation Type	Market Share	Pricing (USD)	Regulatory Status	Unique Features
DILAUDID-HP	Extended-release capsule	Leading in hydromorphone niche	Premium	Strict, REMS in US	Potent, long-acting hydromorphone
OxyContin	Extended-release oxycodone	Largest opiod in US	$20-$50 per tablet	Highly regulated	Larger market share, widespread familiarity
MS Contin (Morphine)	Extended-release morphine	Widely used	$10-$30 per dose	Strict	Historic standard opioid

---

Future Outlook and Innovation

Potential Growth Opportunities

• Formulation Innovation: Combination products (e.g., abuse-deterrent formulations), transdermal systems.
• Market Expansion: Focusing on emerging markets with growing pain management needs.
• Integration with Pain Management Protocols: Multimodal approaches reducing reliance solely on opioids.

Regulatory and Policy Shifts Impacting DILAUDID-HP

• Increasing adoption of abuse-deterrent formulations to mitigate misuse.
• US FDA’s Opioid Analgesic REMS urging tighter prescription controls.
• Moves towards medical cannabis and non-opioid alternatives, which could reduce demand.

Key Challenges

• Balancing pain management needs vs. societal risks.
• Addressing opioid misuse and addiction concerns through responsible prescribing.
• Navigating complex regulatory landscapes for market access.

---

Key Takeaways

• Market Position: DILAUDID-HP holds a niche segment as a potent, long-acting opioid for severe pain, primarily in North America.
• Growth Drivers: Demographic shifts, aging populations, and unmet needs in chronic pain sustain demand; however, regulatory constraints are a persistent headwind.
• Revenue Trajectory: Moderate growth projected in stable regions; significant upside in emerging markets with regulatory improvements.
• Competitive Landscape: Dominated by brand loyalty with increasing generic penetration; innovation in formulations might enhance competitiveness.
• Risk Factors: Regulatory tightening, societal backlash, and competition from non-opioid therapies pose risks to sustained revenue growth.

---

FAQs

1. How will regulatory changes impact DILAUDID-HP’s market?
Regulatory tightening, including stricter prescribing guidelines and REMS, will likely limit volume growth, emphasizing the importance of compliance and possibly reducing overall market size.

2. What are the primary competitors to DILAUDID-HP?
Main competitors include other extended-release opioids like OxyContin (oxycodone), MS Contin (morphine), and generic hydromorphone formulations, with competition based on pricing, formulation features, and prescriber preferences.

3. Is DILAUDID-HP being developed in new formulations?
While specific pipeline projects are proprietary, industry trends point toward abuse-deterrent formulations and alternative delivery systems to meet regulatory standards and market needs.

4. What role do emerging markets play in DILAUDID-HP’s future?
Growing healthcare infrastructure and increasing pain management needs in Asia-Pacific and Latin America present substantial growth opportunities, albeit with regulatory and distribution challenges.

5. How are societal attitudes toward opioids influencing the market?
Heightened awareness of addiction risks is leading to more conservative prescribing, increased monitoring, and a shift toward multimodal pain management, potentially constraining growth but ensuring safer usage.

---

References

1. IQVIA Institute for Human Data Science. (2022). The Global Use of Medicines in Pain Management.
2. FDA. (2021). Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics.
3. European Medicines Agency. (2022). Guidelines on Opioid Prescribing.
4. Evaluate Pharma. (2022). Opioid Market Analysis & Forecast.
5. CDC. (2018). Understanding the Opioid Epidemic: Data and Policy.