PALLADONE Drug Patent Profile

Which patents cover Palladone, and what generic alternatives are available?

Palladone is a drug marketed by Purdue Pharma Lp and is included in one NDA.

The generic ingredient in PALLADONE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Palladone

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

Summary for PALLADONE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	1
Patent Applications:	2,124
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PALLADONE
DailyMed Link:	PALLADONE at DailyMed

Recent Clinical Trials for PALLADONE

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

Sponsor	Phase
University of Miami	Phase 2

See all PALLADONE clinical trials

US Patents and Regulatory Information for PALLADONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004		DISCN	No	No
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004		DISCN	No	No
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004		DISCN	No	No
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004		DISCN	No	No

Expired US Patents for PALLADONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004	5,958,452
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	6,706,281
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004	6,743,442
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	5,968,551
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004	5,965,161
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	6,335,033
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	5,958,452

International Patents for PALLADONE

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

Country	Patent Number	Title	Estimated Expiration
Finland	942092
Japan	3647897
Hungary	218673	Opioid analgetikumot tartalmazó elnyújtott hatóanyag-felszabadítású orális gyógyszerkészítmény és eljárás előállítására (CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION FOR ORALLY ADMINISTRATION COMPRISING OPIOID ANALGESIC AND PROCESS FOR PRODUCING ITS)
Austria	196079
United Kingdom	9324045
Finland	921548
Canada	2127166	COMPOSITIONS DE MORPHINE A LIBERATION PROLONGEE ET METHODE DE PREPARATION (SUSTAINED RELEASE MORPHINE COMPOSITIONS AND A METHOD OF PREPARATION)

Market Dynamics and Financial Trajectory for PALLADONE

Last updated: February 20, 2026

What is PALLADONE and its current market status?

PALLADONE is a formulation of hydromorphone, an opioid analgesic used to treat severe pain. Manufactured by Purdue Pharma, PALLADONE was approved in 1998 and marketed primarily in the United States. It extends the release of hydromorphone over 24 hours, offering long-acting pain relief. The drug faced market withdrawal in 2005 after concerns over abuse and misuse.

What are the key market factors influencing PALLADONE?

1. Regulatory Environment

• The U.S. Food and Drug Administration (FDA) withdrew PALLADONE in 2005 due to safety concerns related to abuse potential.
• Similar withdrawal or restricted access occurred in other jurisdictions, reflecting a global tightening of opioid regulations.
• Legislation like the Drug Enforcement Administration (DEA) scheduling and the CDC guidelines aim to curb opioid abuse.

2. Market Competition

• PALLADONE's primary competitors include other long-acting opioids such as OxyContin (oxycodone), MS Contin (morphine sulfate), and extended-release formulations of hydromorphone.
• These alternatives vary in safety profiles, abuse-deterrent features, and regulatory status; most are still in use, limiting opportunities for PALLADONE’s re-entry.

3. Patent & Intellectual Property

• PALLADONE's original patent expired before 2005, diminishing exclusivity.
• No significant new patents or formulations have emerged to reposition PALLADONE within the market.

4. Prescribing Trends

• Growing awareness of opioid addiction has shifted prescribing practices toward multimodal pain management and non-opioid therapies.
• Prescription rates for long-acting opioids have declined significantly post-2005.

5. Safety and Abuse-Deterrent Technologies

• The market favors formulations with abuse-deterrent features, reducing misuse potential.
• PALLADONE lacks such innovations, undermining its viability compared to newer products.

How has the financial trajectory evolved?

1. Revenue History

• In 2004, PALLADONE's revenue peaked before the withdrawal, generating an estimated $72 million annually in the U.S. (source: IMS Health).
• Post-2005, revenue ceased due to withdrawal, with minimal residual income from existing inventory or legal settlements.

2. Market Exit and Impact on Purdue Pharma

• The withdrawal resulted in an immediate loss of sales for Purdue.
• Purdue faced significant legal liabilities related to opioid marketing and safety issues, affecting overall corporate financial health.
• No reported reintroduction plans for PALLADONE since 2005.

3. Broader Market Trends

• The global opioid market contracted in the late 2000s and early 2010s due to regulatory crackdowns.
• Opportunities for long-acting opioids have become constrained amidst increased litigation and reformulation requirements.

What are the prospects for future commercialization?

• Reintroduction of PALLADONE faces significant barriers: regulatory restrictions, market competition, and the opioid epidemic’s stigma.
• Any potential revival would require reformulation with abuse-deterrent features and new indications, along with substantial clinical trials and regulatory approval.

Summary of the current market landscape

Aspect	Status	Notes
Regulatory Environment	Stringent, withdrawal in 2005	Ongoing opioid regulation tightening
Market Competition	High, dominated by other long-acting opioids	Abuse-deterrent formulations preferred
Patent & IP	Expired, no new patents	Limited barriers for competitors
Prescribing Trends	Declining for long-acting opioids	Shift to non-opioid pain management
Revenue & Financials	Ceased after 2005 withdrawal	No current revenue reported
Re-entry prospects	Low; requires reformulation and regulatory approval	Market barriers remain high

Key Takeaways

• PALLADONE’s market presence effectively ended in 2005 after regulatory withdrawal.
• The opioid market’s evolution favors abuse-deterrent, non-abusable formulations.
• Competitive landscape favors established alternatives with safety profiles.
• Future reintroduction is unlikely without significant reformulation and regulatory clearance.
• Legal and societal pressures will continue to diminish opportunities for long-acting opioid re-entry.

FAQs

1. Why was PALLADONE withdrawn from the market?
PALLADONE was withdrawn due to safety concerns over its abuse potential, leading to regulatory action by the FDA in 2005.

2. Are there any plans to reintroduce PALLADONE?
There are no public plans. Reintroduction would require reformulation with abuse-deterrent technology and new regulatory approval.

3. How does PALLADONE compare to other opioids?
Before withdrawal, PALLADONE offered once-daily long-acting pain relief comparable to other formulations like OxyContin but lacked modern abuse-deterrent features.

4. What impact did the withdrawal have on Purdue Pharma’s revenue?
The loss of PALLADONE sales in 2005 significantly impacted Purdue’s revenue, contributing to the company’s broader legal and financial issues.

5. Will increased regulation affect future opioid development?
Yes. Stricter regulations and societal concern over opioid misuse challenge the development and market entry of new long-acting opioids.

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References

[1] IMS Health. (2004). Market analysis report for opioids.
[2] FDA. (2005). Letter of withdrawal for PALLADONE.
[3] CDC. (2016). Guideline for prescribing opioids for chronic pain.
[4] Purdue Pharma. (n.d.). Company reports and statements on opioid products.
[5] U.S. Drug Enforcement Administration. (2021). Controlled substances scheduling.