ZILRETTA Drug Patent Profile

Which patents cover Zilretta, and when can generic versions of Zilretta launch?

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-one patent family members in twenty-two countries.

The generic ingredient in ZILRETTA is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-three 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 TARO on October 1^st, 1986.

Summary for ZILRETTA

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	17
Patent Applications:	4,313
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
Ohio State University	Phase 4
Sorrento Therapeutics, Inc.	Phase 2
ROC Foundation	Phase 4

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	9,555,048
Pacira Pharms Inc	ZILRETTA	triamcinolone acetonide	FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR	208845-001	Oct 6, 2017		RX	Yes	Yes	8,828,440		Y

International Patents for ZILRETTA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112013002601	corticosteróides para o tratamento de dor em articulação
Russian Federation	2642279	КОРТИКОСТЕРОИДЫ ДЛЯ ЛЕЧЕНИЯ СУСТАВНОЙ БОЛИ (CORTICOSTEROIDS FOR JOINT PAIN TREATMENT)
European Patent Office	2600836	CORTICOSTÉROÏDES POUR LE TRAITEMENT DE LA DOULEUR ARTICULAIRE (CORTICOSTEROIDS FOR THE TREATMENT OF JOINT PAIN)
South Africa	201300831	CORTICOSTEROIDS FOR THE TREATMENT OF JOINT PAIN

ZILRETTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZILRETTA

Introduction to ZILRETTA

ZILRETTA, developed by Pacira BioSciences, is the first and only extended-release, intra-articular injection for osteoarthritis knee pain. It combines triamcinolone acetonide (TA) with poly lactic-co-glycolic acid (PLGA) to provide extended therapeutic concentrations in the joint and a persistent analgesic effect[4].

Market Acceptance and Utilization

Since its launch in the United States in October 2017, ZILRETTA has seen significant market acceptance. The product's permanent J code (J3304), effective from January 1, 2019, has provided predictable reimbursement, enhancing its utilization in existing practices and penetration into new accounts. By the end of 2019, Pacira had sold more than 175,000 units of ZILRETTA, reflecting a growth of over 220% in sales compared to the previous year[4].

Revenue Growth

Quarterly Performance

In the fourth quarter of 2023, ZILRETTA net product sales were $28.7 million, a slight increase from $28.0 million in the fourth quarter of 2022. Similarly, in the second quarter of 2024, ZILRETTA net product sales were $30.7 million, up from $29.3 million in the second quarter of 2023[1][2].

Full-Year Performance

For the full year 2023, ZILRETTA net product sales reached $111.1 million, an increase from $105.5 million in 2022. This growth indicates a steady demand for the product despite the broader market dynamics[1][3].

Market Expansion and Clinical Trials

Pacira is actively expanding the product label for ZILRETTA through clinical trials. Currently, the company is enrolling patients in Phase 2 trials for ZILRETTA in both shoulder osteoarthritis (OA) and adhesive capsulitis. This expansion could significantly increase the market potential for ZILRETTA, given the large number of injections administered for these conditions annually[4].

Competitive Landscape

ZILRETTA operates in a market where immediate-release steroids and hyaluronic acids (HAs) are common treatments for osteoarthritis. However, ZILRETTA's extended-release mechanism provides enhanced and durable pain relief, making it an attractive alternative. According to market research, physicians are open to new treatment options like ZILRETTA due to the limitations of traditional treatments[4].

Financial Impact and Margins

The implementation of the 340B Drug Pricing Program in October 2022 has had a mixed impact on Pacira's financials. While it has led to a lower net selling price for EXPAREL, it has not directly affected ZILRETTA's pricing. However, any future legislative changes or pricing adjustments could influence ZILRETTA's margins. The overall volume growth and market expansion efforts are expected to offset any short-term profitability pressures[1][3].

Revenue Projections and Guidance

For 2023, Pacira projected ZILRETTA net product sales to be between $110 million and $115 million. These projections align with the actual full-year sales of $111.1 million, indicating a well-managed sales strategy and market penetration[5].

Key Drivers for Future Growth

• Legislative Support: Initiatives like the NOPAIN Act, which incentivize non-opioid treatments, could expand market opportunities for ZILRETTA.
• Clinical Trials: Successful outcomes from ongoing and future clinical trials for additional indications such as shoulder OA and adhesive capsulitis could significantly boost sales.
• Market Expansion: Continued penetration into new accounts and expansion of the product's use in existing practices will be crucial for sustained growth[3].

Challenges and Considerations

• Pricing Pressures: The impact of pricing programs like the 340B Drug Pricing Program on margins needs to be closely monitored.
• Competition: The competitive landscape in OA treatments is dynamic, and new products or technologies could challenge ZILRETTA's market position.
• Regulatory Environment: Changes in regulatory policies or reimbursement structures could affect the product's sales and profitability[1][3].

Conclusion

ZILRETTA has established itself as a significant player in the osteoarthritis treatment market, with steady revenue growth and expanding market opportunities. As Pacira continues to invest in clinical trials and market expansion, ZILRETTA is poised for further growth, despite the need to navigate pricing pressures and competitive market dynamics.

Key Takeaways

• ZILRETTA is the first extended-release, intra-articular injection for osteoarthritis knee pain.
• The product has seen significant market acceptance and utilization since its launch.
• Full-year 2023 sales reached $111.1 million, with a steady increase from the previous year.
• Ongoing clinical trials for additional indications are expected to drive future growth.
• Legislative support and market expansion are key drivers for the product's financial trajectory.

Frequently Asked Questions (FAQs)

Q: What is ZILRETTA, and how does it work? A: ZILRETTA is an extended-release, intra-articular injection for osteoarthritis knee pain. It combines triamcinolone acetonide (TA) with poly lactic-co-glycolic acid (PLGA) to provide extended therapeutic concentrations in the joint and a persistent analgesic effect[4].

Q: How has ZILRETTA performed in terms of sales? A: ZILRETTA has shown steady revenue growth. In 2023, full-year net product sales were $111.1 million, up from $105.5 million in 2022[1][3].

Q: What are the key drivers for ZILRETTA's future growth? A: Key drivers include legislative support from initiatives like the NOPAIN Act, successful outcomes from clinical trials for additional indications, and continued market expansion[3].

Q: How does the 340B Drug Pricing Program affect ZILRETTA? A: The 340B Drug Pricing Program has not directly affected ZILRETTA's pricing but has impacted EXPAREL's pricing. However, any future pricing adjustments could influence ZILRETTA's margins[1][3].

Q: What are the potential challenges for ZILRETTA in the market? A: Challenges include pricing pressures from programs like the 340B Drug Pricing Program, competition from other OA treatments, and changes in the regulatory environment[1][3].

Sources:

1. Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2023 Financial Results - Pacira BioSciences Investor Relations[1].
2. Pacira BioSciences Reports Second Quarter 2024 Financial Results - Pacira BioSciences Investor Relations[2].
3. Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2023 Financial Results - Stock Titan[3].
4. Annual Report 2019 - Pacira BioSciences[4].
5. Pacira BioSciences Reports Third Quarter 2023 Financial Results - BioSpace[5].