AVITA Drug Patent Profile

Which patents cover Avita, 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-eight 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

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

International Patents for AVITA

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

Country	Patent Number	Title	Estimated Expiration
Austria	115553
Canada	1331861	METHODE ET COMPOSITIONS POUR AUGMENTER LA PENETRATION CUTANEE D'AGENTS PHARMACEUTIQUES ACTIFS (METHOD AND COMPOSITIONS FOR ENHANCING THE CUTANEOUS PENETRATION OF PHARMACOLOGICALLY ACTIVE AGENTS)
Germany	3852437
European Patent Office	0299758	Compositions augmentant la pénétration cutanée d'agents pharmaceutiquement actifs. (Compositions for enhancing the cutaneous penetration of pharmacologically active agents.)
Spain	2065912
Greece	3015410
Ireland	66710	Compositions for enhancing the cutaneous penetration of pharmacologically active agents

Supplementary Protection Certificates for AVITA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322

Last updated: February 3, 2026

What Is the Current Investment and Fundamentals Outlook for AVITA?

AVITA Medical develops regenerative medicine therapies focused on wound management and skin regeneration. Its flagship product, Recell, is marketed for burn, trauma, and surgical wounds. As of 2023, AVITA’s market position remains niche, with growth prospects driven primarily by product approval extensions and geographic expansion.

How Does AVITA’s Product Line Impact Its Financial Performance?

AVITA’s revenue hinges on sales of Recell, with recent growth influenced by regulatory approvals in various jurisdictions. Historically, the company has reported limited profitability, with net losses driven by R&D investments and marketing costs.

Item	2020	2021	2022 (est.)
Revenue (USD millions)	7.2	12.5	~15.3
Net Loss (USD millions)	(15.4)	(20.3)	~(25.4)
Cash & Equivalents (USD millions)	50.0	45.7	40.2

Note: Data approximated from recent filings and estimates.

How Does AVITA’s Market Position Compare With Competitors?

The regenerative medicine segment includes players like ReGen Biologics, Cytograft Tissue Engineering, and Medgel. AVITA's distinctive selling point is the use of its autologous skin-cell harvesting process. However, it faces competition from traditional skin grafts and advanced wound care products.

Company	Market Focus	Revenue (USD millions)	Market Share (Estimate)
AVITA Medical	Cell-based wound coverage, regenerative skin	12.5 (2021)	2-4%
ReGen Biologics	Tissue engineering for orthopedic applications	Not publicly disclosed	<1%
Cytograft Tissue Eng.	Vascular tissue regeneration	Small niche	<1%

Market share remains limited, constraining AVITA’s revenue scalability without expansion efforts.

What Are Key Regulatory and Geographic Expansion Drivers?

AVITA is approved in Australia, the US, and select European countries. Regulatory approval in Japan (obtained in 2022) opens access to the world's third-largest healthcare market.

The company's future growth depends on regulatory approvals in additional markets such as China and Brazil, along with increased adoption by healthcare providers. The approval process in emerging markets typically involves lengthy and costly trials, although local partnerships could expedite entry.

What Are the Investment Risks for AVITA?

• Limited Profitability: Ongoing losses from R&D and marketing efforts may pressure financials.
• Regulatory Uncertainty: Extended timelines and stringent standards could delay or block approvals.
• Market Penetration: COVID-19 pandemic disruptions and slow adoption hinder revenue growth.
• Competitive Landscape: Traditional therapies and larger biotech firms with higher resources could erode market share.
• Funding Needs: Capital requirements for expansion and R&D could dilute shareholder value or necessitate additional financing.

What Are the Growth Catalysts for AVITA?

• Regulatory Milestones: Achieving approvals in Japan, China, and other emerging markets.
• Revenue Expansion: Increasing sales in existing markets through hospital adoption.
• Product Pipeline: Development of next-generation regenerative products focusing on diabetic ulcers or chronic wounds.
• Strategic Partnerships: Collaborations with hospitals, research institutions, or pharma companies to accelerate commercialization.

How Do Financial Valuations Reflect the Company’s Prospects?

As of 2023, AVITA’s enterprise value approximates USD 150 million, with a market cap near USD 100 million, reflecting its early-stage status. The valuation considers its limited revenue, ongoing losses, and growth potential.

Metric	Valuation Impact
Revenue (USD millions)	Low, due to only ~15 million in recent sales
Net Loss (USD millions)	High, indicating pre-profit stage
Market Capitalization	Slight premium for growth potential

Valuations are sensitive to approval success, market expansion, and revenue growth.

Key Takeaways

• AVITA is a niche player in regenerative wound care with limited revenue but rising in regulatory approvals.
• The company's growth relies on expanding into Asian markets and enhancing product adoption.
• Financial risk remains due to consistent losses and funding requirements.
• Market competition favors established therapies and larger firms with better resources.
• Strategic partnerships and pipeline development are critical to build valuation.

FAQs

1. What is AVITA's primary product?
Recell, a regenerative skin therapy used primarily for burns, trauma, and surgical wounds.

2. What are the main markets for AVITA?
Australia, the United States, and select European countries, with recent expansion into Japan.

3. What is the company’s revenue outlook?
Revenue is expected to grow modestly as market penetration increases, but significant scale depends on regulatory approvals and adoption.

4. What are the key risks associated with investing in AVITA?
Regulatory hurdles, ongoing losses, limited market share, competition from established treatments, and need for capital infusion.

5. What potential catalysts could drive AVITA’s valuation?
Successful market entries in Asia, approval of new indications, pipeline advancements, and strategic partnerships.

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Citations:

1. AVITA Medical Inc. Annual Report 2022
2. Bloomberg finance data on AVITA 2023 valuation
3. Market research reports on regenerative medicine (Global Market Insights, 2022)
4. Regulatory filings and approvals (FDA, PMDA, EMA)