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. Seventeen 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
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	102
Patent Applications:	4,704
Drug Prices:	Drug price information for DILAUDID
Drug Sales Revenues:	Drug sales revenues for DILAUDID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DILAUDID
What excipients (inactive ingredients) are in DILAUDID?	DILAUDID excipients list
DailyMed Link:	DILAUDID at DailyMed

See drug prices for DILAUDID

See drug sales revenues for DILAUDID

Recent Clinical Trials for DILAUDID

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

Sponsor	Phase
University of Miami	Phase 2
The Cleveland Clinic	N/A
Hennepin Healthcare Research Institute	Phase 4

See all DILAUDID clinical trials

Pharmacology for DILAUDID

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

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			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No			Y
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	AP	RX	Yes	Yes			Y
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-007	Feb 10, 2017	AP	RX	Yes	Yes			Y

Expired US Patents for DILAUDID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-001	Dec 7, 1992
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-002	Nov 9, 2007
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009

International Patents for DILAUDID

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

Country	Patent Number	Title	Estimated Expiration
Canada	2389193
Japan	2003513980
European Patent Office	2003134	Compositions d'hydromorphinone (Hydromorphinone compositions)
Portugal	2968729

DILAUDID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dilaudid

Introduction to Dilaudid

Dilaudid, generically known as hydromorphone, is a potent Schedule II opioid analgesic used for the relief of moderate-to-severe pain. It is marketed under various forms, including injectable ampules, multiple dose vials, tablets, and suppositories[1][3][5].

Medical Uses and Market Demand

Dilaudid is prescribed for patients requiring continuous, around-the-clock pain relief, particularly in hospital settings for postoperative pain, severe injuries, and chronic conditions like cancer. Its rapid pain-relieving effects make it a crucial medication in managing acute pain episodes effectively[3][5].

Market Size and Prescription Trends

The total prescriptions dispensed for hydromorphone in the United States remained relatively stable between 2012 and 2015, according to the IQVIA National Prescription Audit™. However, the misuse and diversion of Dilaudid have been significant concerns, with various DEA field offices reporting incidents of pharmacy robberies and diversion[1].

Financial Aspects: Pricing and Revenue

The street price of Dilaudid varies widely, ranging from $5 to $100 per 4 mg tablet depending on the region. This variability highlights the lucrative but illicit market for the drug. Legitimately, the cost of Dilaudid can be substantial, contributing to financial difficulties for those misusing the drug. For example, individuals may face financial devastation due to the high price of Dilaudid, leading to economic problems and even criminal activities to fund their habit[1][2][3].

Abuse and Diversion Impact on Market

The diversion of Dilaudid is a significant issue, with reports from multiple DEA field offices across the United States. This diversion not only affects the legitimate market but also fuels the illicit trade, impacting the overall financial trajectory of the drug. The DEA’s National Forensic Laboratory Information System (NFLIS) has reported a notable number of hydromorphone cases, indicating ongoing misuse and diversion[1].

Regulatory Environment

As a Schedule II controlled substance, Dilaudid is subject to strict regulations. The Drug Enforcement Administration (DEA) and other regulatory bodies closely monitor its prescription and distribution to mitigate abuse and diversion. This regulatory environment can influence the market dynamics by limiting the supply and ensuring that only legitimate medical needs are met[1][3][4].

Competitive Landscape

Dilaudid operates within a competitive opioid market that includes other potent opioids like morphine, oxycodone, fentanyl, and methadone. The competition is driven by the need for effective pain management solutions, and Dilaudid's strong analgesic properties make it a preferred choice in certain medical scenarios. However, the high potential for abuse and addiction also means that prescribers often consider alternative non-opioid analgesics, which can impact Dilaudid's market share[3][4][5].

Economic Impact of Misuse and Addiction

The economic impact of Dilaudid misuse and addiction is substantial. Individuals struggling with addiction may experience financial devastation, including job loss, divorce, and incarceration due to theft or forging prescriptions. Additionally, the healthcare system bears significant costs related to treating addiction and managing the complications associated with Dilaudid abuse[2][3][5].

Treatment and Rehabilitation Market

The need for treatment and rehabilitation services for Dilaudid addiction has created a parallel market. Facilities like the Greenhouse Treatment Center offer various levels of care, including detoxification, counseling, and long-term recovery programs. This market segment is growing as more individuals seek help for opioid addiction, contributing to the overall financial trajectory of the drug[5].

Future Outlook

Given the ongoing opioid crisis and the high potential for abuse associated with Dilaudid, the future market dynamics are likely to be influenced by stricter regulatory measures and increased focus on alternative pain management strategies. The development of non-opioid analgesics and innovative treatment options for opioid addiction will also play a crucial role in shaping the market.

Key Statistics

• Approximately 11.5 million people aged 12 and older reported misusing prescription opioids like Dilaudid at least once in the previous year, according to the National Survey on Drug Use and Health (NSDUH)[3].
• The DEA’s NFLIS reported 839 cases of hydromorphone in 2021, 643 in 2022, and 356 in 2023 (reports still pending)[1].

Expert Insights

"Opioids, like Dilaudid, act on reward centers in the brain, causing intense euphoria in some users when taken in high doses or for long periods of time. Over time, tolerance and physical dependence can occur," notes an expert from the addiction treatment field. This highlights the dual nature of Dilaudid as both a valuable medical tool and a substance with high abuse potential[5].

Highlight: Regulatory Concerns

"Schedule II opioid agonists, including morphine, oxycodone, oxymorphone, fentanyl and methadone, have the highest potential for abuse and risk of fatal respiratory depression. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion."[4]

Key Takeaways

• Dilaudid is a potent opioid with significant medical use but high potential for abuse and addiction.
• The market is influenced by regulatory measures, diversion, and misuse.
• Financial impacts include both legitimate revenue and illicit trade, as well as economic burdens on individuals and the healthcare system.
• The future outlook is shaped by the development of alternative pain management strategies and increased focus on treatment and rehabilitation.

FAQs

Q: What is Dilaudid used for? A: Dilaudid is used for the relief of moderate-to-severe pain, particularly in patients requiring continuous, around-the-clock pain relief.

Q: Why is Dilaudid considered high-risk? A: Dilaudid has a high potential for abuse and addiction due to its powerful effects on the brain’s reward system and opioid receptors.

Q: What are the common side effects of Dilaudid? A: Common side effects include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.

Q: How does Dilaudid lead to addiction? A: Dilaudid leads to addiction by altering the brain’s chemistry, producing intense feelings of euphoria and pain relief, and triggering the release of dopamine.

Q: What are the financial impacts of Dilaudid misuse? A: Financial impacts include financial devastation, job loss, divorce, and incarceration due to theft or forging prescriptions.

Cited Sources

1. Diversion Control Division Drug & Chemical Evaluation Section - Hydromorphone.
2. Addiction Center - Dilaudid Symptoms and Warning Signs.
3. Grove Treatment - Dilaudid Addiction: Effects, Risks, Symptoms, Causes & Treatment.
4. FDA - DILAUDID® and DILAUDID-HP® INJECTION 1 mg/mL, 2 mg/mL.
5. Greenhouse Treatment - Dilaudid Addiction: Side Effects, Withdrawal & Treatment.