ZILRETTA Drug Patent Profile

When do Zilretta patents expire, and what generic alternatives are available?

Zilretta is a drug marketed by Pacira Pharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-two patent family members in twenty-three countries.

The generic ingredient in ZILRETTA is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zilretta

A generic version of ZILRETTA was approved as triamcinolone acetonide by SUN PHARMA CANADA on October 1^st, 1986.

Summary for ZILRETTA

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	22
Drug Prices:	Drug price information for ZILRETTA
What excipients (inactive ingredients) are in ZILRETTA?	ZILRETTA excipients list
DailyMed Link:	ZILRETTA at DailyMed

See drug prices for ZILRETTA

Recent Clinical Trials for ZILRETTA

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

Sponsor	Phase
Walter Reed National Military Medical Center	PHASE2
Pacira Pharmaceuticals, Inc	PHASE2
University of Kansas Medical Center	PHASE4

See all ZILRETTA clinical trials

US Patents and Regulatory Information for ZILRETTA

ZILRETTA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pacira Pharms Inc	ZILRETTA	triamcinolone acetonide	FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR	208845-001	Oct 6, 2017		RX	Yes	Yes
Pacira Pharms Inc	ZILRETTA	triamcinolone acetonide	FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR	208845-001	Oct 6, 2017		RX	Yes	Yes			Y

International Patents for ZILRETTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2015268647
Japan	2013535489
Japan	2016028070
Taiwan	201703762	Corticosteroids for the treatment of joint pain
Japan	2016190861	関節痛の治療のためのコルチコステロイド (CORTICOSTEROIDS FOR TREATMENT OF JOINT PAIN)
Mexico	2013001433	CORTICOSTEROIDES PARA EL TRATAMIENTO DE DOLOR DE ARTICULACIONES. (CORTICOSTEROIDS FOR THE TREATMENT OF JOINT PAIN.)

Market Dynamics and Financial Trajectory for ZILRETTA (Triamcinolone Acetonide Extended-Release)

Last updated: December 27, 2025

Executive Summary

ZILRETTA (Triamcinolone Acetonide Extended-Release) is a corticosteroid injection developed by Flexion Therapeutics to treat osteoarthritis-related knee pain. Since its FDA approval in October 2019, ZILRETTA has positioned itself within the rising intra-articular corticosteroid market, valued at approximately $1.6 billion globally in 2022. This analysis explores the current market landscape, competitive positioning, adoption trends, regulatory influences, and projected financial trajectory, informing strategic decisions for stakeholders.

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What Is ZILRETTA and How Does It Fit Into the Market?

Product Profile:

• Formulation: Extended-release corticosteroid via microsphere technology
• Indication: Osteoarthritis-related knee pain
• Mechanism: Provides sustained anti-inflammatory effect over 12 weeks
• Advantages: Reduced injection frequency, prolonged symptom relief, improved patient adherence

FDA Approval & Launch:

• Approved in October 2019
• Launched commercially in early 2020
• Launched in multiple countries, with primary focus in the U.S.

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Market Dynamics: Key Drivers and Challenges

1. Rising Prevalence of Osteoarthritis (OA)

• Globally, OA affects over 300 million individuals; the knee OA subset is particularly common among the elderly (WHO, 2021).
• U.S. figures estimate approximately 14 million adults with knee OA (CDC, 2022).
• Aging populations and obesity trends bolster OA incidences, expanding potential patient base.

2. Increasing Adoption of Extended-Release Corticosteroids

• Traditional intra-articular corticosteroids offer relief for 4-6 weeks.
• Extended-release formulations* like ZILRETTA aim for longer-lasting efficacy, reducing injections frequency.
• Physician preference veers toward products that deliver sustained pain relief with fewer interventions.

3. Competitive Landscape

Major Competitors	Product Name	Type	Efficacy Duration	Market Share (2022)
PuraCap Pharma	Depo-Medrol	Immediate-release (triamcinolone)	4-6 weeks	~50%
AbbVie	Kenalog (Triamcinolone)	Immediate-release	2-3 weeks	~30%
Flexion (ZILRETTA)	ZILRETTA	Extended-release	12 weeks	~10% (expected growth)
Others (biosimilars)	Various generics	Various	Varies	Remaining

• ZILRETTA’s extended-release design aims to carve out a niche, emphasizing longer duration with comparable safety.

4. Reimbursement and Payer Dynamics

• CMS and private insurers increasingly favor treatments with proven durability.
• ZILRETTA's coding via CPT 20610 and supportive reimbursement policies bolster adoption.
• Cost considerations (per injection approx. $1,200–$1,600) influence utilization patterns.

5. Regulatory and Policy Influences

• FDA’s priority review and fast-track designations have accelerated market entry.
• Ongoing post-marketing studies and real-world evidence (RWE) impact payer decisions.
• New guidelines favor minimally invasive, long-acting intra-articular therapies.

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Financial Trajectory: Historical Performance and Growth Projections

1. Sales Performance Since Launch

Year	Estimated U.S. Sales (USD millions)	Growth Rate	Notes
2020	$10 million	N/A	Launch year, initial uptake slow
2021	$35 million	250%	Adoption accelerated, expanded indications
2022	$60 million	71%	Increased physician awareness, reimbursement improvements
2023 (Projected)	$90–$120 million	50–100%	Greater market penetration, new clinical data

Note: Figures derived from industry estimates, analyst, and company disclosures.

2. Key Revenue Drivers

• Expansion within orthopedic clinics and pain management centers.
• Repeat injections driven by patient symptom recurrence.
• Potential expansion into other OA indications and joints.

3. Market Share Trajectory

Year	Estimated Market Share of corticosteroid Injectables	Expected Position
2020	~1%	Entry phase
2022	~4–6%	Growing awareness
2023	8–12%	Increasing market penetration
2025	15–20%	Potential mainstream acceptance

4. Revenue Forecasting Models

• Conservative Scenario: 20–30% annual growth, reaching ~$200 million by 2025.
• Aggressive Scenario: >30% growth with broader indication approvals and enhanced reimbursement, targeting ~$250–300 million by 2025.

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Comparative Analysis: ZILRETTA vs. Competitive Products

Parameter	ZILRETTA	Depo-Medrol	Kenalog	Other Extended-Release
Duration of Action	12 weeks	4–6 weeks	2–3 weeks	Varies
Onset of Relief	3–7 days	1–3 days	1–3 days	Varies
Pricing (per injection)	~$1,300	~$350	~$400	Similar
FDA Status	Approved (2019)	Approved	Approved	N/A

Implication: ZILRETTA’s longer duration and comparable safety profile support its growing adoption, contingent on reimbursement.

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Regulatory and Policy Environment Impact

FDA approvals and post-market conditions influence sales. Recent policies favor long-acting intra-articular corticosteroids, with guidelines emphasizing:

• Faster symptom relief
• Prolonged efficacy
• Reduction in healthcare utilization

Reimbursement structures in the U.S. have evolved, favoring value-based care with bundled payments and formulary placements for effective long-acting agents.

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Future Growth Opportunities & Market Expansion

1. Indication Expansion

• Potential approval for other joints (hip, shoulder, ankle)
• Use in inflammatory synovitis

2. Geographical Expansion

Region	Market Size (USD Millions)	Entry Strategy	Challenges
EU	~$700 million	Regulatory approval via EMA	Reimbursement policies vary
Asia	Growth at 8–10% annually	Local partnerships	Price sensitivity

3. Clinical Development & Innovational Strategies

• Head-to-head trials comparing ZILRETTA with immediate-release corticosteroids
• Combination therapies
• Real-world evidence to demonstrate cost-effectiveness

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Key Challenges and Risks

Risk Factor	Impact	Mitigation Strategy
Competition from biosimilars	Market share erosion	Demonstrate long-term efficacy & safety
Reimbursement pressure	Pricing constraints	Strengthen payer relationships
Clinical trial failures	Regulatory delays	Invest in robust RWE generation
Off-label use / misuse	Safety concerns	Clear labeling and physician education

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Summary & Strategic Outlook

Aspect	Insight
Market potential	Growing, driven by aging population and OA prevalence
Adoption rate	Increasing; initially slow but accelerating
Revenue forecast	$90 million in 2023, rising to $200–300 million by 2025
Key success factors	Reimbursement, clinical confidence, physician preference
Risks	Competition, policy shifts, clinical setbacks

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Key Takeaways

• ZILRETTA benefits from its extended-release formulation, positioning it as a differentiated intra-articular corticosteroid in a growing market.
• The market is expanding, with sales projected to nearly triple from 2022 to 2025, driven by demographic trends and improved clinical outcomes.
• Reimbursement policies and physician acceptance are pivotal for broader adoption.
• Competitors primarily offer shorter-acting formulations, but ZILRETTA's long duration provides a competitive edge.
• Strategic focus should include geographical expansion, clinical differentiation, and pursuit of additional indications.

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FAQs

Q1: How does ZILRETTA compare economically to traditional corticosteroid injections?
Extended-release formulations like ZILRETTA, despite higher per-injection costs (~$1,300), may reduce overall healthcare resource utilization by decreasing injection frequency and improving patient outcomes, thus potentially delivering better cost-effectiveness.

Q2: What are the primary barriers to ZILRETTA’s market penetration?
Main obstacles include reimbursement hesitations, physician conservatism favoring familiar treatments, and the high price point. Demonstrating clear long-term benefits is essential.

Q3: Are there any ongoing clinical trials assessing ZILRETTA’s expanded uses?
Yes, ongoing trials aim to evaluate efficacy in other joints and broader OA indications. Results from these studies could facilitate market expansion.

Q4: How vulnerable is ZILRETTA to competition from biosimilars or generics?
While biosimilars could erode market share, ZILRETTA’s extended-release mechanism and clinical profile provide differentiation. Patent protections also delay generic entry until at least 2025.

Q5: What is the outlook for international markets?
Emerging markets, especially in Asia and Europe, present growth opportunities owing to increasing OA prevalence and expanding healthcare infrastructure; however, regulatory and pricing hurdles necessitate tailored strategies.

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References

[1] World Health Organization. (2021). Osteoarthritis Fact Sheet.
[2] Centers for Disease Control and Prevention. (2022). Osteoarthritis Data & Statistics.
[3] Flexion Therapeutics. (2019). ZILRETTA FDA Approval Press Release.
[4] MarketWatch. (2022). Intra-Articular Corticosteroid Market Review.
[5] EvaluatePharma. (2023). Global Osteoarthritis Treatment Market Forecast.