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. Seventeen 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:	24
Clinical Trials:	1
Patent Applications:	4,953
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	021044-002	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004

International Patents for PALLADONE

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	9423498
Canada	2123160	FORMULATION A LIBERATION CONTROLEE (CONTROLLED RELEASE FORMULATION)
Australia	7445594
Bulgaria	62473
Slovakia	78694	SOLID MEDICAMENTOUS FORM WITH REGULATED RELEASE OF DRUG AND METHOD OF ITS PREPARING
European Patent Office	1504758

PALLADONE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for PALLADONE

Introduction

PALLADONE, an extended-release formulation of hydromorphone, was once a significant player in the opioid market, particularly for managing severe pain in opioid-tolerant patients. However, its market dynamics and financial trajectory have been significantly impacted by several factors, including safety concerns, regulatory actions, and market competition.

Indications and Usage

PALLADONE is indicated for the management of pain in opioid-tolerant patients that is severe enough to require daily, around-the-clock, long-term opioid treatment. It is not intended for as-needed (prn) analgesia and is reserved for patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate[1].

Safety Concerns and Regulatory Actions

One of the most critical factors affecting PALLADONE's market dynamics is the significant safety concern related to its interaction with alcohol. A pharmacokinetic study revealed that co-ingestion of PALLADONE with alcohol results in dangerous increases in peak plasma concentrations of hydromorphone, which can be lethal even in opioid-tolerant patients. This led the FDA to request that Purdue Pharma voluntarily suspend sales and marketing of PALLADONE in the United States due to an unfavorable risk versus benefit profile[4].

Market Impact of Safety Concerns

The suspension of PALLADONE's sales and marketing in the U.S. has had a profound impact on its market presence. The drug is no longer available for purchase in the U.S., significantly reducing its global market share and revenue. This decision was based on the FDA's analysis of pharmacokinetic data showing the potentially fatal interaction between PALLADONE and alcohol[4].

Financial Trajectory

Prior to its suspension, PALLADONE was part of a larger opioid market valued at billions of dollars. For instance, the global opioids market, which includes hydromorphone hydrochloride, was valued at US$22.74 billion in 2023[2].

However, the financial trajectory of PALLADONE itself has been severely curtailed. Without sales in the U.S., one of the largest pharmaceutical markets, the drug's revenue has plummeted. The financial impact is further exacerbated by the lack of ongoing sales and marketing efforts, which are crucial for maintaining market presence and generating revenue.

Market Competition

The opioid market is highly competitive, with numerous other opioids and analgesics available. The absence of PALLADONE from this market has allowed other products to fill the gap. For example, Indivior's SUBLOCADE, a buprenorphine injection for opioid use disorder, has seen significant growth and is projected to reach over $1.5 billion in annual net revenue by the end of 2025[3].

Conversion and Dosing Considerations

For patients who were previously on PALLADONE, healthcare providers must convert them to other opioid formulations. The process involves careful calculation and monitoring to ensure stable pain management and to avoid signs of opioid withdrawal or over-sedation/toxicity. This complexity adds another layer of challenge in maintaining patient care and highlights the need for alternative, safer options[1].

Global Market and Patent Landscape

While PALLADONE is no longer available in the U.S., the global market for hydromorphone hydrochloride remains active. There are numerous international patents, trade names, and applicants involved in the production and distribution of hydromorphone hydrochloride. However, the specific financial trajectory of PALLADONE itself is largely irrelevant in this broader context due to its removal from the U.S. market[2].

Conclusion on Market Dynamics

The market dynamics for PALLADONE are characterized by a significant decline due to safety concerns and subsequent regulatory actions. The drug's removal from the U.S. market has led to a loss of revenue and market share, allowing other opioid products to dominate the market.

Key Takeaways

• Safety Concerns: PALLADONE's interaction with alcohol led to its suspension in the U.S. market.
• Regulatory Actions: FDA requested the voluntary suspension of PALLADONE's sales and marketing.
• Market Impact: The drug is no longer available in the U.S., significantly reducing its global market share and revenue.
• Financial Trajectory: PALLADONE's revenue has plummeted due to the lack of sales and marketing efforts.
• Market Competition: Other opioid products have filled the gap left by PALLADONE.

FAQs

Q: Why was PALLADONE suspended from the U.S. market? A: PALLADONE was suspended due to a potentially fatal interaction with alcohol, which significantly increases peak plasma concentrations of hydromorphone[4].

Q: What are the indications for PALLADONE? A: PALLADONE is indicated for the management of pain in opioid-tolerant patients that is severe enough to require daily, around-the-clock, long-term opioid treatment[1].

Q: How does the suspension of PALLADONE affect its financial trajectory? A: The suspension has led to a significant reduction in revenue and market share, as the drug is no longer available for purchase in the U.S.[4].

Q: What are the alternatives for patients who were previously on PALLADONE? A: Patients must be converted to other opioid formulations, which involves careful calculation and monitoring to ensure stable pain management[1].

Q: What is the current status of the global market for hydromorphone hydrochloride? A: The global market remains active, with numerous international patents and trade names involved in the production and distribution of hydromorphone hydrochloride, although PALLADONE itself is no longer a part of this market[2].

Sources

1. Palladone: Package Insert / Prescribing Information - Drugs.com
2. HYDROMORPHONE HYDROCHLORIDE - Generic Drug Details - Drug Patent Watch
3. Capital Markets Day - Indivior
4. Information for Healthcare Professionals: Hydromorphone Hydrochloride Extended-Release Capsules - FDA
5. Alcohol-associated rapid release of a long-acting opioid - CMAJ