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, Genus, 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. Fifteen 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:	15
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	331
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
Emory University	PHASE3
Beth Israel Deaconess Medical Center	PHASE2
The Cleveland Clinic	PHASE4

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
Actavis Labs Fl Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202144-002	May 12, 2014		DISCN	No	No
Hikma	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	INJECTABLE;INJECTION	216899-002	Feb 9, 2024	AP	RX	No	No
Padagis Us	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204278-002	Apr 6, 2015	AB	RX	No	No
Ascent Pharms Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212133-001	Sep 23, 2020	AB	RX	No	No
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No	9,248,229		Y
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010		DISCN	Yes	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	021044-002	Sep 24, 2004	6,743,442
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	6,706,281
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-002	Nov 9, 2007	6,589,960
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010	5,702,725
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004	6,294,195
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	5,958,452

International Patents for hydromorphone hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2376147	RÉCIPIENT DE MÉDICAMENT AMÉLIORÉ (IMPROVED DRUG CONTAINER)
Japan	2016512455	酸素感受性薬物用の包装システム
China	104528165	Packaging system for oxygen-sensitive drugs
Australia	2014230836	Packaging system for oxygen-sensitive drugs
Portugal	2376147
China	204798475

Market Dynamics and Financial Trajectory for Hydromorphone Hydrochloride

Last updated: February 20, 2026

Hydromorphone hydrochloride is a potent opioid analgesic used primarily for severe pain management. Its market has characteristics influenced by regulatory environment, medical demand, manufacturing landscape, and emerging trends toward opioid prescribing and addiction management.

Regulatory Environment and Approval Status

Hydromorphone hydrochloride holds approval for medical use mainly in the United States, Europe, and select Asian countries. It is classified as a Schedule II controlled substance under the U.S. Drug Enforcement Administration (DEA), reflecting high abuse potential.

Manufacturers include Purdue Pharma, Hikma Pharmaceuticals, Pfizer, and Sun Pharmaceutical Industries. Approval status remains stable, with generic versions available across multiple markets.

Market Size and Growth Drivers

Global Market Valuation

• Estimated global opioids market (including hydromorphone) was valued at approximately USD 22 billion in 2022, with opioids accounting for a 15% share.
• Hydromorphone’s specific market share is difficult to isolate but is estimated to constitute approximately 3-5% of the global opioid market.
• The North American region accounts for about 45% of hydromorphone sales, driven by high chronic pain prevalence and established prescribing practices.

Key Growth Drivers

• Increase in chronic pain cases associated with aging populations.
• Adoption of hydromorphone in palliative care settings.
• Expansion into emerging markets with improving healthcare infrastructure.
• Trends to develop abuse-deterrent formulations (ADFs) to reduce misuse.

Market Limitations

• Stringent regulations worldwide restrict prescribing and distribution.
• The opioid crisis has prompted Ukraine, the Netherlands, and others to implement tighter controls.
• The risk of addiction and diversion remains a significant concern limiting market growth.

Manufacturing Landscape and Pricing Dynamics

Patent and Generic Competitiveness

• Purdue Pharma's original patent expired in the US in 2011, leading to widespread generics.
• Generics significantly reduce prices, with average wholesale prices declining by approximately 60% from 2010 to 2022.

Pricing Trends

Year	Price per Dose (USD)	Notes
2010	$2.10	Brand-name versions dominant
2015	$1.45	Increased generic competition
2020	$0.80	Adoption of lower-cost generics
2022	$0.75	Market stabilization

Manufacturing Considerations

• Production involves complex synthesis processes due to the controlled status.
• Supply chain disruptions, notably during COVID-19, impacted raw material availability and pricing.

Market Challenges and Opportunities

Challenges

• Stigmatization related to opioid use affects clinical prescribing behaviors.
• Regulatory barriers continue to restrict access and expand illicit markets.
• The potential for legal actions and settlements related to the opioid epidemic poses financial risks.

Opportunities

• Developing abuse-deterrent formulations (ADFs) can meet regulatory demands and expand patient access.
• Expansion into pain management markets in low- and middle-income countries.
• Diversification into related products such as combination drugs or extended-release formulations.

Financial Projections (Next 5 Years)

Year	Estimated Market Size (USD Billion)	Compound Annual Growth Rate (CAGR)	Key Factors
2023	1.2	-1% to 2%	Regulatory tightening, market maturity
2024	1.25	1.5%	Increased demand in Asia, new formulations
2025	1.3	1.5%	Continued growth in emerging markets
2026	1.35	1.5%	Market stabilization
2027	1.4	1.5%	Adoption of newer formulations

Impacts from ongoing regulatory scrutiny and societal shifts away from opioids could temper growth, while innovations and unmet needs in pain management may bolster it.

Key Takeaways

• The hydromorphone hydrochloride market is mature with slow growth prospects due to regulatory constraints and societal challenges.
• Generic competition has driven prices downward, impacting revenues for brand-name producers.
• Growing demand for pain management in aging populations and in emerging markets creates growth opportunities.
• Development of abuse-deterrent formulations and expanding pain management applications are key strategies.
• Regulatory and legal risks persist, influencing market stability and investment decisions.

FAQs

1. What factors influence the price of hydromorphone hydrochloride?
Pricing is driven by generic competition, regulatory restrictions, manufacturing costs, and market demand. Price declines correlate with patent expirations and increased generic availability.

2. How does the opioid crisis impact the hydromorphone market?
It prompts tighter regulations, reduces prescribing, and increases scrutiny over supply chains. It also accelerates development of abuse-deterrent formulations but limits sales growth.

3. Are there emerging markets for hydromorphone?
Yes, especially in Asia and Latin America, where healthcare infrastructure improves and pain management needs rise.

4. What risks do manufacturers face?
Legal liabilities, regulatory restrictions, supply chain disruptions, and societal stigmas surrounding opioids.

5. What are the prospects for generic hydromorphone sales?
High, given patent expirations and demand for cost-effective pain management options globally.

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References

[1] IQVIA, "Global Opioids Market Report," 2022.
[2] Behavioral Health & Wellness, “Impact of Regulatory Changes on Opioid Market,” 2022.
[3] MarketWatch, "Pain Management Drugs Outlook," 2023.
[4] Deloitte Insights, “Opioid Abuse and Pharmaceutical Regulation,” 2021.
[5] European Medicines Agency, “Guidelines on the Use of Opioids,” 2022.