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Last Updated: December 23, 2024

KADIAN Drug Patent Profile


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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. Thirty 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 30th, 1992.

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Summary for KADIAN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 24
Clinical Trials: 16
Patent Applications: 7,378
Drug Prices: Drug price information for KADIAN
What excipients (inactive ingredients) are in KADIAN?KADIAN excipients list
DailyMed Link:KADIAN at DailyMed
Drug patent expirations by year for KADIAN
Drug Prices for KADIAN

See drug prices for KADIAN

Drug Sales Revenue Trends for KADIAN

See drug sales revenues for KADIAN

Recent Clinical Trials for KADIAN

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

SponsorPhase
University of British ColumbiaPhase 4
The Ottawa HospitalPhase 3
Bruyere Research InstitutePhase 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 020616-008 Apr 20, 2007 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-010 Jul 9, 2012 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-009 Jul 9, 2012 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-007 Feb 27, 2007 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-006 Oct 27, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 020616-002 Jul 3, 1996 ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-007 Feb 27, 2007 ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-008 Apr 20, 2007 ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-006 Oct 27, 2006 ⤷  Subscribe ⤷  Subscribe
Allergan KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-005 Mar 9, 2001 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for KADIAN

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

Country Patent Number Title Estimated Expiration
European Patent Office 0377518 Composition pharmaceutique à libération retardée (Sustained release pharmaceutical composition) ⤷  Subscribe
Spain 2120562 ⤷  Subscribe
Austria 167629 ⤷  Subscribe
Australia 4773290 ⤷  Subscribe
Japan 2937376 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

KADIAN Market Analysis and Financial Projection Experimental

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.

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