AVINZA Drug Patent Profile

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

Avinza is a drug marketed by King Pharms Llc and is included in one NDA.

The generic ingredient in AVINZA 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 Avinza

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

Summary for AVINZA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	7
Patent Applications:	4,675
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVINZA
What excipients (inactive ingredients) are in AVINZA?	AVINZA excipients list
DailyMed Link:	AVINZA at DailyMed

See drug sales revenues for AVINZA

Recent Clinical Trials for AVINZA

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

Sponsor	Phase
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1
Isfahan University of Medical Sciences	Phase 2/Phase 3

See all AVINZA clinical trials

Paragraph IV (Patent) Challenges for AVINZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVINZA	Extended-release Capsules	morphine sulfate	45 mg and 75 mg	021260	1	2009-08-11
AVINZA	Extended-release Capsules	morphine sulfate	30 mg, 60 mg, 90 mg and 120 mg	021260	1	2007-06-04

US Patents and Regulatory Information for AVINZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-001	Mar 20, 2002		DISCN	No	No
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-006	Dec 18, 2008		DISCN	No	No
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-005	Dec 18, 2008		DISCN	No	No
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-002	Mar 20, 2002		DISCN	No	No
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-004	Mar 20, 2002		DISCN	No	No
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-003	Mar 20, 2002		DISCN	No	No

Expired US Patents for AVINZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-003	Mar 20, 2002
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-001	Mar 20, 2002
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-004	Mar 20, 2002
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-006	Dec 18, 2008
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-002	Mar 20, 2002
King Pharms Llc	AVINZA	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021260-005	Dec 18, 2008

International Patents for AVINZA

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1023051
Japan	4535613
Japan	2001520187
South Africa	9809463
Canada	2558783	FORMULATION ORALE MULTIPARTICULAIRE DE MORPHINE (ORAL MORPHINE MULTIPARTICULATE FORMULATION)
Austria	239454
Germany	69721845

AVINZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AVINZA

Introduction

AVINZA, an extended-release formulation of morphine sulfate, is a significant player in the opioid market, particularly for the management of moderate to severe chronic pain. This article delves into the market dynamics and financial trajectory of AVINZA, highlighting its acquisition, market performance, clinical efficacy, and the broader context of opioid use.

Acquisition and Strategic Significance

In 2006, King Pharmaceuticals, Inc. announced the acquisition of AVINZA from Ligand Pharmaceuticals Incorporated for $265 million. This transaction was part of King's strategic plan to strengthen its neuroscience portfolio and establish a stronger presence in pain management[1].

Market Performance

At the time of the acquisition, AVINZA had already demonstrated strong market performance. Retail sales of AVINZA totaled approximately $179 million in 2005, according to IMS Health Incorporated data. The opioid market was projected to exceed $7 billion by 2009, driven by factors such as an aging population, better physician training in pain management, and increasing patient demand for effective pain control[1].

Clinical Efficacy

AVINZA has been clinically proven to be effective in managing chronic moderate to severe pain. Studies have shown that once-daily AVINZA significantly reduces pain scores, improves sleep quality, and enhances physical functioning in patients with chronic pain. For example, a study involving 491 patients with chronic non-cancer pain showed a significant reduction in mean daily pain scores and improvements in sleep and physical functioning over a three-month period[3].

Pharmacokinetics and Dosage

AVINZA is designed for once-daily administration, providing a steady-state plasma concentration profile that maintains therapeutic levels of morphine over a 24-hour period. The formulation includes both an immediate release and an extended release component, ensuring rapid and sustained pain relief. The bioavailability of AVINZA is comparable to other oral morphine formulations, with a plateau-like plasma concentration profile achieved within 2 to 3 days of once-daily dosing[4].

Market Positioning

The acquisition of AVINZA was a strategic move by King Pharmaceuticals to bolster its pain franchise. AVINZA complemented King's existing products, such as SKELAXIN, and positioned the company to leverage its expanded sales force to promote AVINZA and other pain management products. The integration of Ligand's sales force nearly doubled King's neuroscience specialty sales team, enhancing the company's market reach and potential[1].

Financial Projections and Performance

The financial trajectory of AVINZA was promising, with significant revenue potential. King Pharmaceuticals anticipated that AVINZA would contribute substantially to its revenue, given the growing demand for effective pain management solutions. The company's commitment to building a stronger portfolio was underscored by its investment in AVINZA and other pain management products, such as REMOXY, an abuse-deterrent opioid in late-stage development[1].

Broader Market Context

The opioid market is complex and influenced by various factors, including regulatory changes, patient demand, and concerns about abuse and diversion. The use of opioids for chronic non-cancer pain is controversial, with evidence of both efficacy and risks such as tolerance, dependence, and abuse. Despite these challenges, opioids remain a crucial component of pain management strategies, with AVINZA being a notable example of an effective extended-release opioid formulation[5].

Regulatory and Compliance Aspects

The marketing and regulatory oversight of AVINZA involve strict guidelines to mitigate the risks associated with opioid use. King Pharmaceuticals, and later Pfizer after subsequent acquisitions, have had to navigate these regulatory requirements, including maintaining control over marketing plans and regulatory filings with the FDA during the transition period[1].

Patient Adherence and Safety

Patient adherence to AVINZA has been high, with studies showing that nearly 90% of patients reported never having forgotten to take the medication. However, it is crucial to monitor patients for potential side effects and to ensure that they are aware of the risks associated with opioid use, such as respiratory depression, constipation, and the potential for abuse and dependence[3][4].

Economic and Health Impact

The economic and health impact of AVINZA is significant. Chronic pain affects over 50 million people in the United States, resulting in substantial healthcare costs and a considerable impact on quality of life. Effective pain management with medications like AVINZA can improve patient outcomes, reduce healthcare utilization, and enhance economic productivity[1][5].

Key Takeaways

• Acquisition and Market Positioning: King Pharmaceuticals acquired AVINZA for $265 million, strengthening its pain management portfolio.
• Clinical Efficacy: AVINZA has been shown to significantly reduce pain scores, improve sleep, and enhance physical functioning in patients with chronic pain.
• Financial Trajectory: AVINZA was expected to contribute substantially to King Pharmaceuticals' revenue, driven by growing demand for pain management solutions.
• Regulatory and Compliance: Strict regulatory oversight is necessary to manage the risks associated with opioid use.
• Patient Adherence and Safety: High patient adherence to AVINZA, but careful monitoring for side effects and risks is essential.

FAQs

What is AVINZA used for?

AVINZA is an extended-release formulation of morphine sulfate used for the management of moderate to severe chronic pain that requires continuous, around-the-clock opioid therapy[2].

Who acquired AVINZA and why?

King Pharmaceuticals acquired AVINZA from Ligand Pharmaceuticals in 2006 to strengthen its neuroscience portfolio and enhance its position in pain management[1].

How effective is AVINZA in managing chronic pain?

Studies have shown that AVINZA significantly reduces pain scores, improves sleep quality, and enhances physical functioning in patients with chronic pain[3].

What are the potential side effects of AVINZA?

Potential side effects include respiratory depression, constipation, nausea, vomiting, and the risk of abuse and dependence[2][4].

How does AVINZA impact the opioid market?

AVINZA is a significant player in the opioid market, contributing to the growing demand for effective pain management solutions while navigating the complexities and risks associated with opioid use[1][5].

Sources

1. King Pharmaceuticals, Inc. Announces Strategic Acquisition Of AVINZA(R) From Ligand Pharmaceuticals Incorporated For $265 Million - Biospace
2. AVINZA- morphine sulfate capsule, extended release - Pfizer
3. A study of AVINZA (morphine sulfate extended-release capsules) for chronic moderate-to-severe noncancer pain - PubMed
4. Label: avinza- morphine sulfate capsule, extended release - DailyMed
5. Opioids in the Management of Chronic Non-Cancer Pain - American Society of Interventional Pain Physicians