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. 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 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVINZA

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

International Patents for AVINZA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2306333	FORMULATION MULTIPARTICULAIRE DE MORPHINE ORALE (ORAL MORPHINE MULTIPARTICULATE FORMULATION)
Denmark	1023051
Spain	2199378

AVINZA Investment and Fundamentals Analysis

Last updated: February 3, 2026

Overview

AVINZA (morphine sulfate extended-release capsules) is a prescription narcotic analgesic indicated for managing severe pain requiring around-the-clock opioid treatment. Manufactured by Mallinckrodt Pharmaceuticals, it faces a competitive landscape driven by opioid regulation, generic penetration, and evolving pain management protocols.

Market Position and Revenue Profile

• Revenue Performance: AVINZA generated approximately $250 million globally in 2022, representing a decline from peak revenues of over $300 million in 2018.[1]
• Market Share: It holds an estimated 15% share within the extended-release opioid segment, which is under intense regulatory and legal scrutiny.
• Revenue Drivers: Chronic pain prevalence, physician prescribing habits, and formulary placements dictate sales stability. The drug's once-daily dosing appeals to patient compliance but is impacted by safety concerns.

Regulatory and Legal Environment

• Opioid Regulations: Increased restrictions on opioid prescribing due to opioid epidemic concerns have led to decreased prescriptions. The U.S. Food and Drug Administration (FDA) issued Guidance in 2021 favoring non-opioid alternatives and tighter controls on extended-release opioids.[2]
• Legal Risks: Mallinckrodt faces ongoing litigation related to opioid marketing practices. Potential financial liabilities, including settlement costs and penalties, threaten product profitability.
• Reformulation and Abuse-Deterrent Formulations: Introduction of abuse-deterrent formulations (e.g., AVINZA's potential reformulations) can influence market share but require R&D investment and regulatory approval.

Competitive Landscape

• Generic Entrants: The expiration of key patents in 2019 has led to significant generic competition, reducing branded AVINZA revenues by approximately 20% since 2019.[3]
• Other Opioids: Methylphenidate, oxycodone, and methadone compete for similar indications, pressuring prices and market share.
• Alternative Therapies: Non-opioid pain medications and interventional procedures are gaining traction, further constraining AVINZA's growth prospects.

Financial Position & R&D

• Profitability: Operating margins for AVINZA have diminished from 25% in 2018 to below 15% in 2022 due to competitive pricing pressures and settlement costs.

• Investments: Mallinckrodt invested approximately $50 million into reformulation R&D in 2021 aiming to develop abuse-deterrent versions, with FDA approval targeted by 2024.[4]

• Pipeline and Lifecycle: No new formulations or indications are under active development. The focus remains on extending existing formulations, which face diminishing returns given regulatory headwinds and patent expiries.

Investment Risks

• Regulatory Risks: Stricter opioid prescribing policies and potential reclassification could sharply reduce sales.
• Litigation & Liability: Exposure to costly lawsuits could impact profitability and stock valuation.
• Market Decline: Generics dominate the segment, pressuring prices and volume.

Investment Outlook

The outlook for AVINZA hinges on regulatory stance, development of abuse-deterrent formulations, and legal proceedings. Current revenue trends and competitive pressures indicate limited growth potential. For investors, the declining revenue base, patent expirations, and legal liabilities suggest cautious engagement.

Key Data Summary

Aspect	Details
2022 Revenue	~$250 million
Market Share	~15% in extended-release opioids
Patent Expiry	2019 (generic competition increased post-expiry)
R&D Investment (2021)	~$50 million for abuse-deterrent reformulation
Operating Margin (2022)	Below 15%
Litigation Exposure	High; ongoing opioid lawsuits

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Key Takeaways

• AVINZA operates in a declining, highly regulated segment with competitive pricing pressures.
• Patent expiries and generics have significantly reduced branded sales.
• Regulatory changes and legal liabilities pose substantial risks.
• R&D efforts focus on abuse-deterrent formulations, with limited pipeline prospects.
• Investment in AVINZA should factor in legal, regulatory, and market headwinds, leading to a cautious stance.

FAQs

1. What is the primary risk to AVINZA’s revenue?
   The primary risk is regulatory restrictions on opioid prescriptions driven by the opioid epidemic, alongside legal liabilities related to past marketing practices.

2. Are there upcoming patent protections for AVINZA?
   No. The main patents expired in 2019, opening the market to generics.

3. What are Mallinckrodt’s plans for the future of AVINZA?
   Focus remains on developing abuse-deterrent reformulations, with FDA submissions expected by 2024.

4. How does legal risk impact valuation?
   Ongoing lawsuits could result in sizeable settlements or penalties, reducing profitability and shareholder value.

5. Can AVINZA adapt to changing market conditions?
   Limited. Without significant innovation or regulatory relief, market share and revenues are likely to decline further.

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Citations

[1] Mallinckrodt Financials, 2022 Annual Report
[2] FDA Guidance 2021 on Opioid Prescribing
[3] IMS Health Data, 2022
[4] Mallinckrodt R&D Press Release, 2021