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. 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

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILAUDID

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
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984		DISCN	Yes	No	9,248,229		Y

International Patents for DILAUDID

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

Country	Patent Number	Title	Estimated Expiration
Japan	4886953
European Patent Office	2003134	Compositions d'hydromorphinone (Hydromorphinone compositions)
Canada	2389193
European Patent Office	2968729	SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
Australia	2018236914	PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS
Mexico	PA02004678	COMPOSICIONES DE HIDROCODEINONA E HDROMORFINONA Y METODOS PARA SU SINTESIS. (HYDROMORPHINONE AND HYDROCODEINONE COMPOSITIONS AND METHODS FOR THEIR SYNTHESIS.)
China	104528165	Packaging system for oxygen-sensitive drugs

Investment Scenario and Fundamentals Analysis for DILAUDID (Hydromorphone HCl)

Last updated: February 20, 2026

What Is DILAUDID and Its Market Position?

DILAUDID (hydromorphone hydrochloride) is a potent opioid analgesic approved for pain management. It is classified as a Schedule II controlled substance in the United States, reflecting its high potential for abuse and dependence. Its primary indication involves moderate to severe pain treatment, typically in hospital or hospice settings.

Regulatory Status and Patent Landscape

DILAUDID itself has no active patent status in the U.S. since its original patent expired decades ago. However, the formulation, manufacturing processes, and delivery methods may have patent protection protected by patents that expire over the next 5-10 years. Even with patent expirations, generic versions dominate the market, limiting revenue potential for original producers unless they develop novel formulations.

Market Size and Trends

Global Opioid Analgesics Market (2023–2030)

Indicator	Value	Notes
Market size (2023)	$9.8 billion	Estimated global sales for opioid analgesics
CAGR (Compound Annual Growth Rate)	3.1%	Driven by aging populations and chronic pain cases
Major regions	North America, Europe	North America accounts for over 60% of sales, driven by high opioid prescribing rates

Key Market Drivers

• Aging populations facing chronic pain conditions
• Hospitals and hospice care reliance on opioids
• Ongoing demand despite regulatory and societal challenges around opioid use

Market Challenges

• Stringent regulatory controls
• Rising litigation over opioid-related issues
• Growth of abuse-deterrent formulations (ADFs)

Competition and Revenue Sources

Generics and Biosimilars

• The market for DILAUDID is primarily supplied by multiple generic manufacturers post-patent expiry.
• Generic hydromorphone is priced 25-40% lower than branded DILAUDID, reducing profit margins for original producers.

New Formulations and Delivery Systems

• Extended-release formulations or abuse-deterrent versions can command premium pricing.
• Industry R&D focuses on novel delivery systems to reduce misuse, though regulatory approvals are lengthy.

Key Players

Company	Market Share	Strategic Moves	Recent Approvals
Purdue Pharma	Declined after bankruptcy	Historically dominant; no longer active due to legal issues	N/A
Teva Pharmaceuticals	Significant	Large generic portfolio, ongoing product launches	N/A
Mylan (now part of Viatris)	Significant	Wide product range including hydromorphone	N/A

Investment Considerations

Positives

• Steady demand in acute care and hospice settings.
• Opportunities to develop abuse-deterrent formulations.
• Potential growth in emerging markets where opioid analgesics are increasingly utilized.

Risks

• Regulatory restrictions limit prescribing and distribution.
• Legal liabilities and litigation costs.
• Shift in pain management practices favoring non-opioid therapies.
• Potential for rescheduling or tighter control laws.

Financial Outlook

• Original patent expiries undermine premium pricing.
• Long-term revenues depend on reformulations and lower-cost generics.
• Industry consolidation could affect supplier dynamics.

Policy and Legal Environment

• The U.S. FDA enforces strict labeling and distribution standards on opioids.
• Recent legislative efforts include Prescription Drug Monitoring Programs (PDMPs) to reduce misuse.
• Federal and state lawsuits target opioid manufacturers, increasing legal liabilities and costs.

Industry R&D Pipeline

• Focus on abuse-deterrent formulations (ADFs).
• Development of transdermal patches, sublingual films, and extended-release versions.
• Investment in non-opioid pain management alternatives remains a strategic priority.

Key Takeaways

• DILAUDID's revenue stability relies on its positioning in hospital and hospice markets.
• Patent expirations and the proliferation of generics suggest limited long-term monopoly benefits.
• Growing regulatory oversight constrains sales growth but emphasizes reformulation development.
• Industry shifts toward non-opioid alternatives threaten overall opioid sales potential.
• Investment viability depends heavily on R&D success in abuse-deterrent and alternative pain therapies.

FAQs

1. What is the future outlook for DILAUDID’s revenue?
Limited, due to patent expiries and rising generic competition. Growth prospects hinge on the development and approval of abuse-deterrent formulations.

2. How do regulatory policies impact DILAUDID sales?
Regulations restrict prescribing practices, dictate distribution controls, and heighten legal scrutiny, reducing volume but potentially increasing demand for safer formulations.

3. Are there significant patent protections on DILAUDID?
No. The original patent expired years ago; current protections focus on formulation patents unlikely to last beyond 2028.

4. What is the competitive landscape?
Dominated by generic producers like Teva and Viatris, with limited differentiation except through abuse-deterrent versions.

5. How might legal actions influence the market?
Ongoing litigation elevates risks of financial liabilities and could lead to tighter regulations, further constraining market growth.

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References

1. Market Research Future. (2023). Global Opioid Analgesics Market. Retrieved from [source].

2. U.S. Food and Drug Administration. (2023). Opioid Analgesic Labeling and Policy. Retrieved from [source].

3. IQVIA. (2022). Market Data and Insights on Pain Management Drugs. Retrieved from [source].

4. Statista. (2023). Pain management drugs revenue by region. Retrieved from [source].

5. U.S. Department of Justice. (2022). Opioid Litigation and Industry Impact. Retrieved from [source].