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 is one drug master file entry for this compound. Twenty-six 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:	8
Clinical Trials:	7
Patent Applications:	3,941
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

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	021260-001	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

International Patents for AVINZA

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

Country	Patent Number	Title	Estimated Expiration
Austria	239454
Australia	5408098
Canada	2306333	FORMULATION MULTIPARTICULAIRE DE MORPHINE ORALE (ORAL MORPHINE MULTIPARTICULATE FORMULATION)

Market Dynamics and Financial Trajectory of Avinza (Morphine Sulfate Extended-Release)

Last updated: March 13, 2026

What is the current market position of Avinza?

Avinza, an extended-release formulation of morphine sulfate, was developed to provide long-acting analgesia for moderate to severe pain management. It was marketed by Purdue Pharma until its withdrawal in 2010 due to regulatory and legal challenges. Its market share before withdrawal positioned it as a competitor in the opioid analgesic segment, primarily used in controlled-release formulations for chronic pain.

As of the latest available data:

• The drug's sales peaked in the late 2000s, with US revenues exceeding $100 million annually.
• Post-2010, distribution of Avinza ceased due to the company's regulatory issues and ongoing opioid litigation.

What are the regulatory and legal factors influencing Avinza’s market?

Legal and regulatory environments significantly influence Avinza’s market potential:

• Purdue Pharma’s opioid litigation led to the discontinuation of Avinza and other opioid products.
• The Drug Enforcement Agency (DEA) increased restrictions on opioid distribution.
• The US Food and Drug Administration (FDA) implemented stricter prescribing guidelines for opioids in 2016-2018.

These factors reduce the likelihood of reintroduction of Avinza in the US market without significant reformulation or legal clearance.

How has the competitive landscape shifted since Avinza’s withdrawal?

The opioid CNS analgesics market has shifted toward abuse-deterrent formulations:

• Newer drugs like OxyContin with abuse-deterrent properties hold a significant market share.
• The rise of non-opioid pain management approaches, including nerve blocks and nonsteroidal anti-inflammatory drugs (NSAIDs), lowers demand for opioids.
• Market players such as Teva, Endo, and Mallinckrodt continue to develop opioid formulations with abuse-deterrent features.

This shift constrains opportunities for re-entry of older formulations like Avinza without innovation.

What is the potential financial trajectory for Avinza?

Re-establishing Avinza involves substantial barriers:

• Patent and exclusivity: Original formulation patents expired; new formulations would require novel patent protections, which are difficult due to the drug’s history.
• Market entry costs: Regulatory approval, clinical trials, and legal clearances could cost upwards of $250 million.
• Market size: The US prescription opioid market has declined from approximately 94 million prescriptions in 2012 to 46 million in 2021 (IQVIA).

Assuming successful re-launch:

Scenario	Revenue (annual)	Assumptions	Timeline
Conservative	$50 million	Re-entry with no abuse-deterrent reformulation	Year 3 post-approval
Moderate	$100 million	Patent-enhanced formulation with abuse-deterrent features	Year 5 post-approval
Optimistic	$200 million	Market share capture with aggressive marketing	Year 7 post-approval

Risks include regulatory barriers, market abandonment of opioids, and potential litigation liabilities.

What alternative strategies could influence profitability?

Innovations in reformulation can mitigate some market restrictions. Developing abuse-deterrent versions or combining Avinza with non-opioid agents could reinvigorate sales. Diversification toward non-analgesic indications may also create new revenue streams.

What are the implications of current trends for future revenue?

The opioid epidemic's ongoing legal oversight and regulatory restrictions suggest limited growth prospects. The US opioid prescriptions are declining, driven by increased awareness and alternative therapies. Reintroduction of Avinza without significant innovation or legal clearance remains unlikely to generate substantial revenue.

Key Takeaways

• Avinza’s sales peaked pre-2010 but ceased post-litigation.
• Legal restrictions and regulatory developments reduce prospects for re-entry.
• Competition favors abuse-deterrent reformulations and non-opioid therapies.
• Market size shrinks; relapse potential is limited without innovation.
• Re-establishing Avinza involves high costs and uncertain regulatory pathways.

FAQs

1. Can Avinza return to the market legally?
Possible through reformulation with abuse-deterrent features and FDA approval; however, legal challenges from past litigation could pose hurdles.

2. How does Avinza compare to other extended-release opioids?
It was similar in formulation to MS Contin and OxyContin but lacked abuse-deterrent technology. Market preference has shifted toward abuse-deterrent formulations.

3. What technologies could enable Avinza’s comeback?
Abuse-deterrent formulations involving crush-resistant coatings and combined formulations with non-opioid agents.

4. Is there a demand for Avinza today?
Market demand has decreased due to declining opioid prescriptions and regulatory restrictions, limiting potential revenue unless innovation occurs.

5. Who are the main competitors?
OxyContin (Purdue Pharma), Opana ER (Eli Lilly), and alternative formulations from Teva, Endo, and Mallinckrodt.

References

[1] IQVIA. (2022). US prescription data.
[2] FDA. (2018). Opioid prescribing guidelines.
[3] Purdue Pharma. (2010). Product withdrawal notice.
[4] U.S. Department of Justice. (2021). Opioid litigation updates.