Hydromorphone hydrochloride - Generic Drug Details

What are the generic drug sources for hydromorphone hydrochloride and what is the scope of freedom to operate?

Hydromorphone hydrochloride is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Fresenius Kabi Usa, Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, Chartwell, Specgx Llc, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Mpp Pharma, and Nesher Pharms, and is included in twenty-nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydromorphone hydrochloride has twenty-two patent family members in twelve countries.

There are nine drug master file entries for hydromorphone hydrochloride. Sixteen suppliers are listed for this compound.

Summary for hydromorphone hydrochloride

International Patents:	22
US Patents:	2
Tradenames:	5
Applicants:	18
NDAs:	29
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	328
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydromorphone hydrochloride
What excipients (inactive ingredients) are in hydromorphone hydrochloride?	hydromorphone hydrochloride excipients list
DailyMed Link:	hydromorphone hydrochloride at DailyMed

Recent Clinical Trials for hydromorphone hydrochloride

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

Sponsor	Phase
The Cleveland Clinic	PHASE4
Beth Israel Deaconess Medical Center	PHASE2
Texas Scottish Rite Hospital for Children	PHASE2

See all hydromorphone hydrochloride clinical trials

Pharmacology for hydromorphone hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for hydromorphone hydrochloride

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for hydromorphone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for HYDROMORPHONE HYDROCHLORIDE

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	Tablets	hydromorphone hydrochloride	2 mg, 4 mg, and 8 mg	019892	1	2013-08-05
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
DILAUDID	Oral Solution	hydromorphone hydrochloride	5 mg/5mL	019891	1	2011-02-25
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	8 mg and 12 mg	021217	1	2010-09-02
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	16 mg	021217	1	2010-08-02

US Patents and Regulatory Information for hydromorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	INJECTABLE;INJECTION	216899-001	Feb 9, 2024	AP	RX	No	No
Hikma	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	217812-001	Dec 14, 2023		RX	Yes	Yes
Aurolife Pharma Llc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	205814-003	May 13, 2016	AB	RX	No	No
Hospira Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	INJECTABLE;INJECTION	200403-003	Dec 1, 2011	AP	RX	No	No
Specgx Llc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	076855-001	Dec 23, 2004	AB	RX	No	No

Expired US Patents for hydromorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-002	Mar 1, 2010

International Patents for hydromorphone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Denmark	2376147
Japan	2016512455	酸素感受性薬物用の包装システム
Japan	5737692
Australia	2014230836	Packaging system for oxygen-sensitive drugs
World Intellectual Property Organization (WIPO)	2010064074

Market Dynamics and Financial Trajectory for Hydromorphone Hydrochloride

Last updated: July 28, 2025

Introduction

Hydromorphone Hydrochloride, a potent opioid analgesic, serves as a critical component in pain management, especially for severe pain in clinical settings. As a semi-synthetic derivative of morphine, it offers rapid onset and potent analgesic effects. However, its market dynamics—characterized by regulatory controls, evolving prescribing practices, and global opioid consumption trends—shape its financial trajectory. This analysis explores these factors, forecast growth patterns, and provides insights for stakeholders.

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Market Overview

Hydromorphone Hydrochloride functions primarily in hospital and palliative care contexts, with a substantial share in managing acute and chronic pain. The drug is marketed under various brand names (e.g., Dilaudid, Exalgo) and in generic formulations, with global revenues driven by increasing opioid prescriptions and expanding palliative care services.

The global opioid analgesics market, valued at approximately USD 8 billion in 2022[^1], is projected to grow at a compound annual growth rate (CAGR) of 3-4% over the next five years. Hydromorphone, within this segment, benefits from robust demand in mature markets such as North America and Europe but faces regulatory and social headwinds.

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Market Drivers

1. Rising Global Burden of Chronic Pain

The increasing prevalence of chronic pain conditions—cancer-related, post-surgical, and non-cancer pain—drives demand for potent analgesics like hydromorphone. An aging population globally further amplifies this need, especially in developed economies.

2. Advancements in Pain Management Protocols

Medical protocols favor opioid use for severe pain, with hydromorphone being preferred for its potency and fewer side effects compared to morphine. Enhanced formulations (e.g., extended-release variants) improve patient compliance and safety, expanding market opportunities.

3. Expansion of Palliative and End-of-Life Care

Growing acceptance and expansion of palliative care services, especially in developing countries, open new markets for hydromorphone. Governments and health organizations increasingly include opioids in essential medicines lists, facilitating access.

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Market Restraints and Challenges

1. Regulatory and Legal Constraints

Stringent regulations aimed at curbing opioid misuse and diversion have significantly limited hydromorphone’s market growth. Many countries have introduced tighter control measures, impacting supply and prescribing practices[^2].

2. Opioid Epidemic and Public Perception

The global opioid crisis, notably in North America, has led to increased scrutiny and restrictions on opioid prescribing. This environment hampers market expansion, favoring alternative pain management strategies and reducing overall consumption.

3. Risk of Abuse and Misuse

Hydromorphone's high potency raises concerns over addiction and misuse, prompting regulatory agencies to impose stringent prescribing protocols, which can limit patient access and sales volume.

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Competitive Landscape

Hydromorphone faces competition from several opioid analgesics, including morphine, oxycodone, fentanyl, and hydrocodone. However, its unique potency and pharmacokinetics position it as a preferred choice in specific clinical niches.

Key market players include Purdue Pharma, Hikma Pharmaceuticals, Sun Pharmaceutical Industries, and generic manufacturers. Patent statuses and formulation innovations (e.g., abuse-deterrent formulations) influence the competitive dynamics.

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Global Market Segmentation

By Geography:

• North America: Dominates due to high opioid consumption, advanced healthcare infrastructure, but faces regulatory hurdles.
• Europe: Moderate growth driven by increasing palliative care services.
• Asia-Pacific: Emerging market harnessing expanding healthcare access and pain management awareness.
• Latin America and Middle East: Limited but growing markets, contingent on regulatory reforms.

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Financial Trajectory and Forecast

Historical Trends

Between 2018 and 2022, the hydromorphone market experienced steady revenue growth aligned with overall opioid analgesics expansion. However, the post-pandemic landscape showed increased restraint owing to regulatory crackdowns and evolving prescribing behaviors.

Future Outlook

Based on current trends, the global hydromorphone market is projected to grow at a CAGR of approximately 2-3% from 2023 to 2028[^3]. Factors influencing this trajectory include:

• Market stabilization in mature regions due to strict regulation.
• Emerging opportunities in Asia-Pacific driven by expanding healthcare infrastructure.
• Developments in formulations—including abuse-deterrent and long-acting options—that can rejuvenate growth.

Revenue Projections

• 2023: Estimated global revenue of USD 400-500 million.
• 2028: Projected revenue nearing USD 550-650 million, contingent on regulatory environments and market access policies.

Potential Disruptors

• Regulatory relaxations or tightenings: Policy changes can significantly influence market size.
• Patient preference shifts: Increased adoption of non-opioid modalities.
• Technological innovations: Novel analgesic formulations could attenuate demand.

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Regulatory Environment

Regulatory agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others enforce strict controls on hydromorphone distribution and prescribing. The implementation of Prescription Drug Monitoring Programs (PDMPs) aims to reduce misuse but complicates supply chains and prescribing autonomy.

In some jurisdictions, hydromorphone is designated as a Schedule II controlled substance, imposing strict prescribing, record-keeping, and dispensing restrictions. This limits growth potential but maintains profitability within approved markets.

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Supply Chain and Manufacturing Considerations

The production of hydromorphone involves complex chemical synthesis with rigorous quality controls. The manufacturing landscape is concentrated among a few large pharmaceutical companies, with generic manufacturers playing a substantial role. Supply chain disruptions—due to regulatory, geopolitical, or raw material sourcing issues—can influence pricing and availability.

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Strategic Considerations for Stakeholders

• Pharmaceutical companies should explore formulation innovations and geographic expansion into niche markets like Asia-Pacific.
• Regulatory compliance and engagement are crucial to navigate evolving legal landscapes.
• Investments in abuse-deterrent formulations can provide a competitive edge amid rising concerns about misuse.
• Partnerships with healthcare providers can facilitate responsible prescribing and access.

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Key Takeaways

• Hydromorphone Hydrochloride remains a vital opioid analgesic, with steady demand driven by severe pain management needs.
• Regulatory constraints and the global opioid epidemic significantly influence its market growth, with a projected CAGR of 2-3% through 2028.
• Market expansion opportunities primarily exist in emerging regions, aided by increasing healthcare infrastructure and palliative care programs.
• Innovation in formulations and adherence to regulatory standards are critical to sustain profitability and market share.
• Stakeholders must balance clinical needs with ethical and legal considerations, leveraging strategic planning to optimize the financial trajectory.

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FAQs

1. How does regulatory oversight impact the hydromorphone market?
Stringent regulations restrict prescribing and distribution, leading to limited market growth but ensuring controlled use and safety.

2. What regions present the best growth opportunities for hydromorphone?
Emerging markets in Asia-Pacific and Latin America offer expanding healthcare infrastructures and increasing acceptance of opioid analgesics.

3. Are there alternatives to hydromorphone that are gaining market share?
Yes, non-opioid analgesics and newer modalities like nerve blocks or neuromodulation are increasingly used, particularly in regions with tight opioid controls.

4. How do formulation innovations influence the market?
Abuse-deterrent and extended-release formulations can rejuvenate market interest and meet regulatory expectations, opening new revenue streams.

5. What is the outlook for generic vs. branded hydromorphone products?
Generics dominate due to cost advantages, but branded formulations with novel features may command premium pricing and market share in specialized settings.

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References

[1] MarketWatch. "Global Opioid Analgesics Market Size, Share & Trends," 2022.
[2] U.S. Drug Enforcement Administration. "Controlled Substances Act Regulations," 2023.
[3] Grand View Research. "Opioid Market Size & Trends," 2023.