DILAUDID-HP Drug Patent Profile

Which patents cover Dilaudid-hp, and what generic alternatives are available?

Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are two patents protecting this drug and four Paragraph IV challenges.

This drug has twenty-two patent family members in twelve countries.

The generic ingredient in DILAUDID-HP 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-hp

A generic version of DILAUDID-HP was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

Summary for DILAUDID-HP

International Patents:	22
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	102
Patent Applications:	1,901
DailyMed Link:	DILAUDID-HP at DailyMed

Recent Clinical Trials for DILAUDID-HP

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-HP clinical trials

Pharmacology for DILAUDID-HP

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for DILAUDID-HP

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-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

US Patents and Regulatory Information for DILAUDID-HP

DILAUDID-HP 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-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984		DISCN	Yes	No			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984		DISCN	Yes	No			Y
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994		DISCN	No	No			Y

Expired US Patents for DILAUDID-HP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994

International Patents for DILAUDID-HP

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

Country	Patent Number	Title	Estimated Expiration
Canada	2389193
Japan	2003513980
European Patent Office	2003134	Compositions d'hydromorphinone (Hydromorphinone compositions)
Portugal	2968729
Japan	2012510330
Spain	2309001

DILAUDID-HP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DILAUDID-HP

Introduction to DILAUDID-HP

DILAUDID-HP, containing the active ingredient hydromorphone hydrochloride, is a high-potency opioid analgesic used for the management of moderate-to-severe pain in opioid-tolerant patients. This medication is part of a broader class of opioid agonists, which are highly regulated due to their potential for abuse and addiction[2][3][5].

Market Need and Indications

DILAUDID-HP is indicated for patients who require higher doses of opioids to manage their pain, particularly those who are opioid-tolerant. This includes patients taking around-the-clock opioids such as at least 60 mg oral morphine per day, or equivalent doses of other opioids. The medication is crucial for patients whose pain is not adequately managed by other treatment options[3][5].

Competitive Landscape

The opioid analgesic market is highly competitive, with several other potent opioids available, such as fentanyl, oxycodone, and morphine. However, DILAUDID-HP stands out due to its high potency and specific indication for opioid-tolerant patients. This niche positioning helps it maintain a significant market share within the opioid analgesic segment[3][5].

Regulatory Environment

The regulatory environment for opioids, including DILAUDID-HP, is stringent due to concerns about abuse, misuse, and addiction. Regulatory bodies such as the FDA closely monitor these medications, and their use is subject to strict guidelines. For instance, DILAUDID-HP is a Schedule II controlled substance, indicating its high potential for abuse and dependence[1][3][5].

Pricing and Reimbursement

The pricing of DILAUDID-HP is influenced by several factors, including production costs, regulatory requirements, and market demand. Given its high potency and specific use in opioid-tolerant patients, DILAUDID-HP tends to be more expensive than some other opioid formulations. Reimbursement policies also play a crucial role, with many health insurance plans covering the cost of DILAUDID-HP for patients who meet the specified criteria[3].

Sales and Revenue

The sales and revenue of DILAUDID-HP are driven by the demand for effective pain management solutions in opioid-tolerant patients. Despite the challenges posed by the opioid crisis and subsequent regulatory scrutiny, DILAUDID-HP continues to generate significant revenue due to its efficacy and the ongoing need for potent opioid analgesics.

Financial Performance

The financial performance of DILAUDID-HP is closely tied to the overall performance of its manufacturer and the broader pharmaceutical industry. Here are some key financial metrics:

• Revenue Growth: The revenue from DILAUDID-HP has seen fluctuations over the years, influenced by changes in regulatory policies, market competition, and public health initiatives aimed at reducing opioid misuse.
• Market Share: DILAUDID-HP maintains a significant market share within the opioid analgesic segment, particularly among opioid-tolerant patients.
• Profit Margins: The profit margins for DILAUDID-HP are substantial due to its high potency and the critical need it fulfills in pain management.

Challenges and Opportunities

Challenges

• Regulatory Scrutiny: The opioid crisis has led to increased regulatory scrutiny, which can impact sales and revenue.
• Public Perception: Negative public perception of opioids can affect prescribing rates and patient acceptance.
• Competition: The market is highly competitive, with other potent opioids available.

Opportunities

• Growing Demand for Pain Management: The need for effective pain management solutions continues to grow, providing a steady demand for DILAUDID-HP.
• Innovation in Delivery Systems: Advances in delivery systems, such as lyophilized formulations, can enhance patient compliance and safety.
• Expanding Indications: Potential expansion of indications to include other types of pain management could increase market share.

Risk Factors

Abuse and Misuse

DILAUDID-HP, like other opioids, carries a high risk of abuse, misuse, and addiction. This risk is a significant factor in its regulatory environment and public perception[2][3][5].

Respiratory Depression

One of the most critical risks associated with DILAUDID-HP is respiratory depression, which can be life-threatening. This risk necessitates careful monitoring and dose adjustment[1][3][5].

Hypotension and Other Adverse Effects

Other risk factors include hypotension, gastrointestinal obstruction, and increased intracranial pressure, which require cautious use and monitoring[1][3][5].

Future Outlook

The future outlook for DILAUDID-HP is complex, influenced by ongoing regulatory changes, public health initiatives, and advancements in pain management therapies.

• Regulatory Evolution: Continued regulatory scrutiny and potential changes in opioid prescribing guidelines could impact sales.
• Innovative Formulations: Development of new formulations or delivery systems could enhance safety and efficacy.
• Market Demand: The persistent need for effective pain management solutions will likely continue to drive demand for DILAUDID-HP.

Key Takeaways

• DILAUDID-HP is a high-potency opioid analgesic specifically indicated for opioid-tolerant patients.
• Regulatory Environment: The medication is subject to strict regulatory guidelines due to its potential for abuse and addiction.
• Market Dynamics: The competitive landscape is influenced by other potent opioids, but DILAUDID-HP maintains a significant market share.
• Financial Performance: Revenue and profit margins are substantial, despite challenges posed by regulatory scrutiny and public perception.
• Risk Factors: Abuse, misuse, respiratory depression, and other adverse effects are critical risk factors.

FAQs

Q: What is DILAUDID-HP used for? A: DILAUDID-HP is used for the management of moderate-to-severe pain in opioid-tolerant patients.

Q: Why is DILAUDID-HP considered high-risk? A: DILAUDID-HP is considered high-risk due to its potential for abuse, misuse, and addiction, as well as its side effects such as respiratory depression.

Q: How is DILAUDID-HP administered? A: DILAUDID-HP can be administered intravenously, subcutaneously, or intramuscularly, with specific dosing guidelines for each method.

Q: What are the common side effects of DILAUDID-HP? A: Common side effects include constipation, nausea, dizziness, drowsiness, and the potential for physical dependence.

Q: Can DILAUDID-HP be used in patients who are not opioid-tolerant? A: No, DILAUDID-HP should only be used in patients who are opioid-tolerant due to the risk of severe respiratory depression and other adverse effects.

Cited Sources

1. FDA Label: DILAUDID® and DILAUDID-HP® INJECTION 1 mg/mL, 2 mg/mL, 4mg/mL, and 10 mg/mL (hydromorphone hydrochloride) C-II[1].
2. NPS MedicineWise: Dilaudid and Dilaudid-HP injections - Medicine - NPS MedicineWise[2].
3. Drugs.com: Dilaudid-HP: Package Insert / Prescribing Information - Drugs.com[3].
4. Mayo Clinic: Hydromorphone (injection route) - Mayo Clinic[4].
5. FDA Label: DILAUDID® INJECTION and DILAUDID-HP® INJECTION Label[5].