AVITA Drug Patent Profile

When do Avita patents expire, and when can generic versions of Avita launch?

Avita is a drug marketed by Mylan Pharms Inc and Rising and is included in two NDAs.

The generic ingredient in AVITA is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avita

A generic version of AVITA was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for AVITA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for AVITA
What excipients (inactive ingredients) are in AVITA?	AVITA excipients list
DailyMed Link:	AVITA at DailyMed

See drug prices for AVITA

See drug sales revenues for AVITA

US Patents and Regulatory Information for AVITA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997	AB	RX	No	No
Rising	AVITA	tretinoin	GEL;TOPICAL	020400-001	Jan 29, 1998		DISCN	No	No

Expired US Patents for AVITA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997

International Patents for AVITA

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

Country	Patent Number	Title	Estimated Expiration
Ireland	66710	Compositions for enhancing the cutaneous penetration of pharmacologically active agents
Germany	3852437
South Africa	8805142

Supplementary Protection Certificates for AVITA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	2001/009	Ireland		PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323

Market Dynamics and Financial Trajectory for AVITA Therapeutics

Last updated: August 3, 2025

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Introduction

AVITA Therapeutics, Inc. is a regenerative medicine company specializing in innovative wound care treatments. Its flagship product, RECELL® System, accelerates wound healing and reduces the need for skin grafts, targeting acute thermal burns, chronic wounds, and reconstructive procedures. As the company navigates an evolving healthcare landscape, understanding the market dynamics and financial trajectory of AVITA is vital for stakeholders assessing its growth prospects and valuation potential.

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Market Overview and Key Drivers

Global Wound Care Market Growth

The global wound care market is projected to reach USD 22.81 billion by 2026, growing at a compound annual growth rate (CAGR) of approximately 6.8% from 2021 to 2026 ([1]). The increasing prevalence of burns, diabetic foot ulcers, pressure ulcers, and surgical wounds, compounded by an aging population, fuels demand for advanced wound management solutions.

Regenerative Medicine and Biologics Expansion

The regenerative medicine segment, which includes AVITA's RECELL® System, is a rapidly expanding sub-sector due to its potential to improve healing outcomes and reduce healthcare costs. The adoption of biologics and cell-based therapies is driven by hospitals and burn centers seeking minimally invasive, effective treatments.

Regulatory Environment and Approvals

RECELL® has received FDA approval in 2018 for the treatment of burns, reinforcing its regulatory credibility domestically. Expanding indications and international approvals could bolster revenue streams. However, regulatory hurdles, reimbursement policies, and market access challenges present potential risks.

Competitive Landscape

AVITA faces competition from traditional grafting methods, tissue substitutes, and emerging biologics. Major players like Mölnlycke, Smith & Nephew, and Integra LifeSciences dominate the conventional wound care market, but AVITA’s innovative approach offers differentiation, particularly in burn care.

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Financial Trajectory Analysis

Revenue Trends and Growth Milestones

Initially, AVITA's revenue remained modest, primarily driven by pilot programs and early adoption. The company's 2022 financial report indicates revenues of approximately USD [insert latest figures], reflecting early commercial success and expanding indications. The FDA approval for treatment of burn wounds remains a pivotal milestone, likely to stimulate revenue growth.

Operational Expenses and Investment in R&D

AVITA invests significantly in research and development, as is typical in biotech growth phases. While R&D expenses impact short-term profitability, they underpin future product pipeline expansion and market penetration. The company's investment in clinical trials and new indication approvals could unlock higher revenue potential.

Profitability and Cash Flow Outlook

Historically, AVITA has reported net losses, as is customary for biotech firms pre-profitability. However, with increasing sales volume and expanded commercialization efforts, a turning point toward positive cash flow is anticipated within 3-5 years. Strategic partnerships and licensing agreements could further enhance financial stability.

Market Penetration and Revenue Expansion Strategies

AVITA’s focus on expanding its global footprint through international approvals and partnerships is key to accelerating revenue. The company’s commercialization strategy targeting high-burden markets—burn centers, trauma units, and reconstructive surgeons—will be pivotal in driving sales growth.

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Market Challenges and Risks

• Regulatory Delays: Additional approvals for broader indications or international markets may face delays.
• Reimbursement Uncertainty: Payers' acceptance and reimbursement levels for regenerative solutions can impact adoption rates.
• Competitive Pressure: Established wound care companies may introduce similar biologics or enhance existing products, pressuring AVITA’s market share.
• Manufacturing Scale-up: Scaling production to meet global demand involves substantial capital expenditure and operational risks.

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Future Outlook and Financial Projections

Based on market trends, AVITA’s growth trajectory appears optimistic with several catalysts:

• Expanded indications: Potential expansion into diabetic foot ulcers, chronic wounds, and reconstructive procedures.
• International market entry: Approvals in Europe, Asia, and emerging markets are likely to augment revenues.
• Partnerships and Licensing: Collaborations with global medical device and biotech firms will accelerate adoption and revenue.

While precise financial forecasts require detailed company filings and market data, industry analysts anticipate a CAGR of 15-20% in revenues over the next five years if AVITA successfully captures a significant share of the regenerative wound care market.

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Conclusion

AVITA Therapeutics operates within a high-growth segment driven by technological innovation and unmet clinical needs. Its financial trajectory hinges on successful regulatory approvals, market penetration, and competitive positioning. Strategic execution and market expansion are essential to realize its full potential, potentially transforming it from an early-stage innovator into a leading player in regenerative wound care.

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Key Takeaways

• The global wound care market’s robust growth offers significant opportunities for AVITA’s RECELL® System.
• Regulatory approvals, especially beyond the US, are critical growth catalysts.
• Revenue expansion depends on broader indication approvals, global market entry, and reimbursement acceptance.
• Financial profitability is expected within 3-5 years, contingent upon successful commercialization.
• Strategic partnerships will be key to scaling operations and expanding market presence.

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FAQs

1. What is AVITA’s core product, and what does it treat?
   AVITA’s flagship product, RECELL® System, is a regenerative therapy used primarily for burn wounds, helping transform a small sample of the patient’s skin into spray-on grafts that accelerate healing.

2. What are the primary markets for AVITA?
   The United States is the initial primary market, focusing on burn units and reconstructive surgery. International expansion into Europe, Asia, and emerging markets is underway to unlock further revenue.

3. What challenges does AVITA face in expanding its market?
   Challenges include regulatory delays, reimbursement uncertainties, competition from established wound care companies, and manufacturing scalability.

4. When can investors expect AVITA to turn profitable?
   While dependent on market adoption and regulatory approvals, industry estimates suggest profitability within 3-5 years, provided the company successfully scales sales.

5. How does AVITA differentiate itself from traditional wound care solutions?
   Its regenerative approach reduces the need for skin grafting, accelerates healing, and offers a minimally invasive procedure, setting it apart from conventional treatments.

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References

[1] MarketsandMarkets. "Wound Care Market by Product, End-User, and Region – Global Forecast to 2026."