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, Nesher Pharms, and Nostrum Labs Inc, 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. Seventeen 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:	17
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	303
Patent Applications:	2,796
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
Johns Hopkins University	Phase 3
Cure Addiction Now	Phase 3
University of Miami	Phase 2

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
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984		DISCN	Yes	No			Y
Chartwell	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	077471-003	Dec 9, 2009		DISCN	No	No
Ascent Pharms Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	210506-002	Jan 17, 2018	AB	RX	No	No

Expired US Patents for HYDROMORPHONE HYDROCHLORIDE

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

International Patents for HYDROMORPHONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2695158
European Patent Office	3424547	SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)
Australia	2018236914	PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS

HYDROMORPHONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydromorphone Hydrochloride

Introduction to Hydromorphone Hydrochloride

Hydromorphone hydrochloride, commonly known by its trade names Dilaudid® and Exalgo®, is a potent schedule II opioid analgesic. It is used for the relief of moderate to severe pain and functions as a μ-opioid receptor agonist, providing analgesia through its interaction with these receptors[2][3].

Global Market Overview

The global opioids market, within which hydromorphone hydrochloride is a significant player, was valued at US$22.74 billion in 2023 and is projected to reach US$26.78 billion by 2034, growing at a CAGR of 1.5% from 2024 to 2034[4].

Segmentation and Market Share

By Application

The pain relief segment holds a major market share, with hydromorphone being a key medication in this category. The pain relief segment accounted for 24% of the market share in 2023[4].

By Route of Administration

The injectable segment has the highest revenue share, with 44% of the market in 2023. However, the oral segment, which includes hydromorphone formulations, is anticipated to expand at a CAGR of 2.5% over the predicted period[4].

By Distribution Channel

The retail pharmacy segment led the market with the maximum market share of 38% in 2023. This indicates that hydromorphone, available through various distribution channels, is predominantly accessed through retail pharmacies[4].

Financial Trajectory of Hydromorphone

Prescription Trends

The total prescriptions dispensed for hydromorphone in the United States remained stable between 2012 and 2015, averaging approximately 3.82 million per year. However, this number decreased to approximately 2.23 million in 2020, 2.22 million in 2021, and 2.16 million in 2022. This decline reflects broader trends in opioid prescribing due to increased regulatory scrutiny and public health concerns[3].

Market Value and Growth

While specific financial data for the hydromorphone market is not provided in isolation, the overall opioids market growth indicates a stable but cautious expansion. The global hydromorphone market is expected to grow, albeit at a moderate pace, driven by the need for effective pain management solutions[1][4].

Key Drivers and Restraints

Drivers

• Demand for Effective Pain Management: The increasing need for managing moderate to severe pain, particularly in post-surgical, trauma, and chronic pain conditions, drives the demand for hydromorphone[4].
• Advancements in Pharmacokinetics: Improvements in drug formulations, such as extended-release and abuse-deterrent formulations, enhance the safety and efficacy of hydromorphone, contributing to market growth[4].

Restraints

• Abuse and Misuse: Hydromorphone has a high abuse and dependence potential, which is a significant restraint. The drug is often diverted through forged prescriptions, "doctor-shoppers," and other illicit means[3].
• Regulatory Scrutiny: Increased regulatory measures to combat the opioid crisis have led to a decrease in prescriptions and a more cautious approach to opioid use, affecting market growth[3].

Geographic Regions

The global hydromorphone market is segmented across various geographic regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America, particularly the United States, has been a significant market due to its high prevalence of opioid use and stringent regulatory environment[1][4].

Competitive Landscape

The opioids market, including hydromorphone, is highly competitive with several key players such as:

• Mallinckrodt Pharmaceuticals LLC
• Purdue Pharmaceuticals L.P.
• Teva Pharmaceuticals Inc.
• Johnson and Johnson
• AbbVie Inc (Allergan PLC)
• Hikma Pharmaceuticals PLC
• Endo Pharmaceuticals Inc.
• Amneal Pharmaceuticals Inc.
• Pfizer Inc.[4]

Innovations and Safety Measures

Abuse-Deterrent Formulations

The shift towards abuse-deterrent formulations is a significant trend. These formulations are designed to deter manipulation of the drug, such as crushing for snorting or injecting, thereby reducing misuse and associated harms[4].

Emergency Treatment

Initiatives like the FDA approval for over-the-counter naloxone hydrochloride nasal spray enhance accessibility for emergency opioid overdose treatment, which can impact the market dynamics by reducing the risks associated with opioid use[4].

Clinical and Therapeutic Use

Hydromorphone is indicated for moderate to severe pain relief. Its pharmacokinetics include an onset of action within 15 to 30 minutes for immediate-release formulations and up to 6 hours for extended-release formulations. The drug is metabolized in the liver and primarily excreted through the urine in its glucuronidated form[2][3].

Challenges and Future Outlook

Opioid Crisis

The ongoing opioid crisis and regulatory pressures continue to shape the market. Efforts to balance pain management needs with safety and reduced abuse potential are crucial for the future growth of hydromorphone and the broader opioids market[3][4].

Public Health Initiatives

Government initiatives, such as the Biden-Harris Administration's $50 million initiative for opioid treatment and recovery services in rural communities, highlight the ongoing commitment to addressing opioid-related issues. These initiatives can influence market dynamics by promoting safer use and reducing misuse[4].

Key Takeaways

• Market Growth: The hydromorphone market is expected to grow moderately, driven by the need for effective pain management.
• Regulatory Environment: Stringent regulations and public health concerns impact prescription trends and market growth.
• Abuse-Deterrent Formulations: Innovations in abuse-deterrent formulations are key drivers for market growth and safety.
• Geographic Focus: North America remains a significant market due to its high prevalence of opioid use.
• Competitive Landscape: The market is highly competitive with several major pharmaceutical companies involved.

Frequently Asked Questions (FAQs)

Q: What is the primary use of hydromorphone hydrochloride? A: Hydromorphone hydrochloride is primarily used for the relief of moderate to severe pain.

Q: What are the common trade names for hydromorphone hydrochloride? A: The common trade names for hydromorphone hydrochloride are Dilaudid® and Exalgo®.

Q: How does hydromorphone hydrochloride work? A: Hydromorphone hydrochloride works as a μ-opioid receptor agonist, providing analgesia through its interaction with these receptors.

Q: What are the main sources of hydromorphone diversion? A: The main sources of hydromorphone diversion include forged prescriptions, "doctor-shoppers," pharmacists and physicians, and armed robberies of pharmacies and nursing homes[3].

Q: What are the potential risks associated with hydromorphone use? A: Hydromorphone use is associated with risks such as respiratory depression, euphoria, feelings of relaxation, reduced anxiety, sedation, constipation, and a high potential for abuse and dependence[2][3].

Cited Sources

1. Global Hydromorphone Market Research Report 2023 - Valuates Reports
2. Dilaudid (hydromorphone) - NCBI - National Institutes of Health (NIH)
3. Hydromorphone - Diversion Control Division, U.S. Department of Justice
4. Opioids Market Size to Worth Around USD 26.78 Billion by 2034 - BioSpace