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 Norvium Bioscience 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-four 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:	100
Patent Applications:	541
Drug Prices:	Drug price information for AVITA
Drug Sales Revenues:	Drug sales revenues 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
Norvium Bioscience	AVITA	tretinoin	GEL;TOPICAL	020400-001	Jan 29, 1998		DISCN	No	No
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997	AB	RX	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
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)
European Patent Office	0299758	Compositions augmentant la pénétration cutanée d'agents pharmaceutiquement actifs. (Compositions for enhancing the cutaneous penetration of pharmacologically active agents.)
Germany	3852437
Greece	3015410
Ireland	882155
Israel	87133	POLYOXYALKYLENE-POLYURETHANE CONTAINING COMPOSITION FOR ENHANCING THE CUTANEOUS PENETRATION OF PHARMACOLOGICALLY ACTIVE COMPOUNDS

Supplementary Protection Certificates for AVITA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
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
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322

AVITA Medical: Navigating Market Dynamics and Financial Trajectory

Introduction

AVITA Medical, a commercial-stage regenerative medicine company, has been making significant strides in the field of wound care management and skin restoration. With its innovative product portfolio and strategic expansions, the company is poised for substantial growth. Here, we delve into the market dynamics and financial trajectory of AVITA Medical.

Strong Financial Performance

AVITA Medical has demonstrated robust financial growth in recent quarters. In the third quarter of 2024, the company reported commercial revenue of $19.5 million, a 44% increase year-over-year. This strong performance is supported by an impressive gross profit margin of 83.7%, which has bolstered analyst confidence in the company's future prospects[2][4].

Revenue Growth and Projections

The company's revenue growth is not limited to the third quarter. Over the last twelve months, AVITA Medical has achieved a substantial 32.24% revenue growth, reaching $60.04 million. For the fourth quarter of 2024, AVITA has provided guidance for commercial revenue between $22.3 million and $24.3 million, indicating continued momentum in its sales trajectory[2][4].

Product Portfolio and Innovation

At the heart of AVITA Medical's success is its innovative product portfolio, centered around the RECELL system. The RECELL system is designed for various regenerative medicine applications and has been a key driver of growth. The company is set to expand its offerings with the anticipated launch of RECELL GO and RECELL GO mini, which are expected to drive incremental growth in 2025 and beyond[1][4].

In addition to these developments, AVITA is working on a comprehensive wound care offering that includes PermeaDerm and Cohealyx. These products, supported by new systems, are poised to strengthen the company's position in the regenerative medicine market and potentially open up new revenue streams[1][4].

Regulatory Progress

Regulatory milestones are crucial for AVITA Medical's growth strategy. The company recently received 510(k) clearance for its Cohealyx product, which is expected to enhance its market penetration capabilities. Furthermore, the FDA approval for RECELL GO mini is anticipated in December 2024, which could significantly expand the company's addressable market and drive future sales[1][4].

Market Expansion

AVITA Medical has announced a strategic expansion into Australia and New Zealand through a distribution agreement. This international expansion is viewed positively by analysts, as it has the potential to increase revenue streams and market share in these new regions. The expansion could diversify the company's revenue streams and reduce dependence on a single market[1][4].

Regulatory Outlook and Challenges

While the regulatory landscape presents opportunities, it also poses challenges. As AVITA Medical enters new markets, it will need to navigate various regulatory environments, which could slow its growth. The company must adapt to new healthcare systems and market dynamics, particularly in regions like Australia and New Zealand[1][4].

Future Outlook and Profitability Projections

Analysts are optimistic about AVITA Medical's path to profitability. The company is projected to reach cash flow breakeven and GAAP profitability by no later than the third quarter of 2025. However, the company is currently burning through cash rapidly, and analysts have revised their earnings expectations downward for the upcoming period. This timeline for achieving profitability is seen as a critical milestone for the company and a key factor in its valuation[1][4].

SWOT Analysis

Strengths

• Strong Year-Over-Year Revenue Growth: AVITA Medical has reported a 44% increase in commercial revenue in Q3 2024.
• Innovative Product Portfolio: The company's RECELL system and upcoming iterations are key drivers of growth.
• Recent Regulatory Clearances: 510(k) clearance for Cohealyx and anticipated FDA approval for RECELL GO mini.
• Strategic Expansion: Entry into new international markets such as Australia and New Zealand[1][4].

Weaknesses

• Increased Operating Expenses: Operating expenses increased significantly to $30.2 million in Q3 2024.
• Net Loss: The company reported a net loss of $16.2 million in Q3 2024, up from $8.7 million in Q3 2023.
• Regulatory Hurdles: Potential challenges in adapting to new regulatory environments and healthcare systems[2][4].

Market Dynamics

Growing Demand for Regenerative Medicine

The demand for regenerative medicine products, particularly in wound care, is on the rise due to factors such as an aging population and the increasing prevalence of chronic wounds. AVITA Medical's comprehensive wound care offering is well-positioned to capture a larger share of this growing market[1][4].

Competitive Landscape

The regenerative medicine market is competitive, but AVITA Medical's innovative products and strategic expansions place it in a strong competitive position. The company's focus on establishing RECELL as the standard of care through expanded commercial reach and medical science liaison teams further solidifies its market leadership[2][4].

Financial Health

Current Financial Position

AVITA Medical maintains a healthy financial position with a current ratio of 3.73, indicating strong liquidity to support its growth initiatives. However, the company is currently experiencing significant cash burn, which is a concern for its short-term financial stability[1][4].

Valuation Model

Analysts use a valuation model based on a one-year forward multiple of 4.0x EV/revenue on revised calendar year 2026 revenue estimates. This model projects the enterprise value to present value as of the end of calendar year 2025, applying a discount rate with a weighted average cost of capital (WACC) of 15%[1].

Key Takeaways

• Robust Revenue Growth: AVITA Medical has demonstrated strong year-over-year revenue growth.
• Innovative Product Portfolio: The company is expanding its offerings with new iterations of the RECELL system and complementary products.
• Regulatory Milestones: Recent and anticipated regulatory clearances are crucial for market expansion.
• International Expansion: Entry into Australia and New Zealand presents new revenue opportunities.
• Path to Profitability: Projected to reach cash flow breakeven and GAAP profitability by Q3 2025.

FAQs

What is the current revenue growth trajectory of AVITA Medical?

AVITA Medical reported commercial revenue of $19.5 million in Q3 2024, a 44% increase year-over-year. The company projects continued growth with Q4 2024 revenue guidance between $22.3 million and $24.3 million[2][4].

What new products is AVITA Medical launching?

AVITA Medical is set to launch RECELL GO and RECELL GO mini, which are expected to drive incremental growth in 2025 and beyond. Additionally, the company is developing a comprehensive wound care offering that includes PermeaDerm and Cohealyx[1][4].

What regulatory milestones is AVITA Medical anticipating?

The company is anticipating FDA approval for RECELL GO mini in December 2024 and has recently received 510(k) clearance for its Cohealyx product[1][4].

How is AVITA Medical expanding its market reach?

AVITA Medical has announced a distribution agreement to expand into Australia and New Zealand, which is expected to increase revenue streams and market share in these new regions[1][4].

When is AVITA Medical expected to reach profitability?

Analysts project that AVITA Medical will reach cash flow breakeven and GAAP profitability by no later than the third quarter of 2025[1][4].

Sources

1. Investing.com: AVITA Medical's SWOT analysis: regenerative medicine stock poised for growth[1].
2. Stock Titan: AVITA Medical Reports Third Quarter Financial Results[2].
3. Listcorp: AVITA Medical Q2 2024 Investor Presentation[3].
4. Investing.com: AVITA Medical's SWOT analysis: regenerative medicine firm's stock poised for growth[4].
5. Aspect Huntley: AVITA Medical Reports Second Quarter Financial Results[5].