KADIAN Drug Patent Profile

When do Kadian patents expire, and when can generic versions of Kadian launch?

Kadian is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in KADIAN is morphine sulfate. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kadian

A generic version of KADIAN was approved as morphine sulfate by HOSPIRA on September 30^th, 1992.

Summary for KADIAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	16
Patent Applications:	4,388
Drug Prices:	Drug price information for KADIAN
What excipients (inactive ingredients) are in KADIAN?	KADIAN excipients list
DailyMed Link:	KADIAN at DailyMed

See drug prices for KADIAN

See drug sales revenues for KADIAN

Recent Clinical Trials for KADIAN

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

Sponsor	Phase
University of British Columbia	Phase 4
Bruyere Research Institute	Phase 3
Ottawa Hospital Research Institute	Phase 3

See all KADIAN clinical trials

US Patents and Regulatory Information for KADIAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-001	Jul 3, 1996		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-004	Mar 9, 2001		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-006	Oct 27, 2006		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-007	Feb 27, 2007		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-008	Apr 20, 2007		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-009	Jul 9, 2012		DISCN	Yes	No
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-010	Jul 9, 2012		DISCN	Yes	No

Expired US Patents for KADIAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-005	Mar 9, 2001
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-002	Jul 3, 1996
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-001	Jul 3, 1996
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-007	Feb 27, 2007
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-001	Jul 3, 1996
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-008	Apr 20, 2007
Allergan	KADIAN	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	020616-002	Jul 3, 1996

International Patents for KADIAN

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

Country	Patent Number	Title	Estimated Expiration
Australia	617573
Austria	167629
European Patent Office	0377518	Composition pharmaceutique à libération retardée (Sustained release pharmaceutical composition)
Germany	69025208
Hong Kong	154296	Sustained release pharmaceutical composition
New Zealand	232029	SUSTAINED RELEASE PHARMACEUTICAL PELLET COMPOSITION COMPRISING A CORE COATING MATERIAL SLIGHTLY SOLUBLE AT LOW PH ALLOWING LATER FASTER RELEASE
Spain	2120562

Market Dynamics and Financial Trajectory for Kadian (Morphine Sulfate Extended-Release Capsules)

Introduction

Kadian, a brand name for morphine sulfate extended-release capsules, is a potent opioid medication used for the management of severe, chronic pain. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its market position, regulatory environment, and financial performance.

Market Position and Indications

Kadian is indicated for the management of pain severe enough to require daily, continuous, long-term opioid treatment, where alternative options are inadequate. It is available in various strengths, including 20, 30, 50, 60, 80, and 100 mg capsules[3][4].

Regulatory Environment

The use of Kadian is heavily regulated due to its potential for addiction, abuse, and misuse. In the United States, the FDA has implemented strict guidelines, including a black box warning highlighting the risks of co-administration with other CNS depressants, overdose, and death. The FDA also requires updated Risk Evaluation and Mitigation Strategy (REMS) programs to educate prescribers and patients about these risks[3].

Market Size and Sales

As of 2016, the annual combined brand and generic sales of morphine sulfate extended-release capsules in the United States were approximately $98.4 million[1]. This figure indicates a significant market presence, driven by the ongoing need for effective chronic pain management.

Generic Competition

The launch of generic versions of Kadian by companies like Impax Laboratories has introduced competition into the market. This competition can lead to price reductions and increased accessibility for patients, but it also affects the revenue of the original brand[1].

Safety and Adverse Events

Kadian carries significant safety risks, including addiction, abuse, and life-threatening respiratory depression. Post-marketing adverse events have been reported, and patients must be carefully monitored for signs of these complications[1][4].

Pharmacokinetics and Clinical Use

Kadian's extended-release formulation allows for slower and more sustained release of morphine, providing steady-state plasma concentrations that are lower at peak and higher at trough compared to conventional oral morphine solutions. This pharmacokinetic profile helps in managing chronic pain effectively but also necessitates careful dosing to avoid adverse effects[4].

Financial Performance

The financial performance of Kadian is influenced by several factors, including market competition, regulatory requirements, and the ongoing opioid crisis. Despite the challenges, Kadian remains a significant player in the opioid market. The generic competition, however, has likely impacted the revenue of the brand name product.

Impact of the Opioid Crisis

The opioid crisis has had a profound impact on the market dynamics of Kadian and other opioid medications. Regulatory bodies have tightened their oversight, and there has been a push for more stringent prescribing practices and education programs. This has led to a decrease in the overall prescription volume of opioids, affecting the financial trajectory of these drugs[3][5].

Cost-Effectiveness and Health Economic Outcomes

While Kadian is effective in managing chronic pain, its cost-effectiveness is a subject of ongoing debate. Similar to other extended-release opioids, Kadian's higher costs compared to immediate-release formulations can be a barrier. However, for patients with severe pain who require long-term treatment, Kadian may offer better health-related quality of life outcomes, justifying its use despite the higher costs[2].

Patient and Clinician Perspectives

From a patient perspective, Kadian offers the benefit of once-daily dosing, which can improve adherence and reduce the complexity of pain management regimens. Clinicians appreciate the predictable pharmacokinetics and the ability to manage severe pain effectively, but they must also be vigilant about the potential for abuse and adverse effects[4].

Future Outlook

The future outlook for Kadian is complex. While it remains a valuable tool in chronic pain management, the ongoing opioid crisis and regulatory scrutiny will continue to shape its market dynamics. Efforts to develop safer, more effective pain management options and to address the opioid epidemic will influence the financial trajectory of Kadian and similar medications.

Key Takeaways

• Market Position: Kadian is a significant player in the opioid market for chronic pain management.
• Regulatory Environment: Strict regulations due to the opioid crisis impact its use and prescribing practices.
• Financial Performance: Affected by generic competition and the opioid crisis.
• Safety and Adverse Events: Carries significant risks that require careful monitoring.
• Pharmacokinetics: Offers predictable and sustained release of morphine.
• Cost-Effectiveness: Higher costs but potentially better health-related quality of life outcomes.

FAQs

What is Kadian used for?

Kadian is used for the management of pain severe enough to require daily, continuous, long-term opioid treatment, where alternative options are inadequate.

What are the key safety concerns associated with Kadian?

Key safety concerns include addiction, abuse, life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome.

How does the generic competition affect Kadian's market?

Generic competition has introduced price reductions and increased accessibility but also affects the revenue of the original brand.

What are the pharmacokinetic advantages of Kadian?

Kadian offers a slower and more sustained release of morphine, providing steady-state plasma concentrations that are lower at peak and higher at trough compared to conventional oral morphine solutions.

How has the opioid crisis impacted Kadian's market dynamics?

The opioid crisis has led to stricter regulations, decreased prescription volumes, and increased scrutiny, affecting the financial trajectory of Kadian.

Is Kadian cost-effective?

Kadian may not be cost-effective in all cases but offers better health-related quality of life outcomes for patients with severe pain requiring long-term treatment.

Sources

1. Impax Laboratories, Inc. - "Impax Launches Generic Version of Kadian® (morphine sulfate) Extended Release Capsules, USP CII" - PR Newswire, December 22, 2016.
2. The Lancet - "Superiority and cost-effectiveness of monthly extended-release buprenorphine versus daily standard of care medication: a pragmatic, parallel-group, open-label, multicentre, phase III randomised controlled trial" - November 16, 2023.
3. Therapeutic Goods Administration (TGA) - "auspar-morphine-sulfate-pentahydrate-190321.pdf" - March 21, 2019.
4. FDA - "40-9068 (morphine sulfate extended-release) Capsules KADIAN" - 2007.
5. United Nations Office on Drugs and Crime - "WORLD REPORT 2018 - Booklet 3: Drug Markets" - 2018.