AVAGE Drug Patent Profile

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

Avage is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in AVAGE is tazarotene. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avage

A generic version of AVAGE was approved as tazarotene by SUN PHARMA CANADA on April 3^rd, 2017.

Summary for AVAGE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	4,655
Drug Prices:	Drug price information for AVAGE
DailyMed Link:	AVAGE at DailyMed

See drug prices for AVAGE

Pharmacology for AVAGE

Drug Class

Retinoid

US Patents and Regulatory Information for AVAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	AB	RX	Yes	Yes

Expired US Patents for AVAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	AVAGE	tazarotene	CREAM;TOPICAL	021184-003	Sep 30, 2002	5,089,509

International Patents for AVAGE

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

Country	Patent Number	Title	Estimated Expiration
Norway	881200
Australia	613346
Japan	S63255277	DISUBSTITUTED ACETYLENE HAVING RETINOID LIKE ACTIVITY
Portugal	86975	PROCESSO DE PREPARACAO DE ACETILENOS DI-SUBSTITUIDOS COM GRUPOS HETEROAROMATICOS E HETEROBICICLICOS APRESENTANDO ACTIVIDADE DO TIPO RETINOIDE E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Hong Kong	5794	DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING RETINOID LIKE ACTIVITY
Austria	76641

Supplementary Protection Certificates for AVAGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
0284288	12/1998	Austria		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: 1-22102, 1-22103 19970918; FIRST REGISTRATION: DE 37393.00.00, 37393.01.00 19961203
0031058	98C0008	Belgium		PRODUCT NAME: TAZAROTENE; NAT. REGISTRATION NO/DATE: NL22604 19970922; FIRST REGISTRATION: DE - 37393.00.00 19961203

Market Dynamics and Financial Trajectory for AVAGE

Last updated: July 30, 2025

Introduction

AVAGE (generic name: isotretinoin) is a potent oral retinoid primarily indicated for severe recalcitrant nodular acne unresponsive to conventional therapy. Originally marketed under brand names such as Accutane, isotretinoin has experienced fluctuations in market share due to regulatory scrutiny, safety concerns, and the advent of alternative therapies. Its unique position within dermatological therapeutics commands an analytical focus on evolving market dynamics and financial trajectories, essential for stakeholders assessing growth potential and competitive strategy.

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Market Overview of AVAGE

Historical Context

Introduced in the 1980s, isotretinoin revolutionized acne treatment, reducing reliance on systemic antibiotics and corticosteroids. It rapidly gained market dominance owing to its high efficacy—upwards of 85% in reducing severe acne with sustained remission [1]. However, concerns over serious adverse effects, including teratogenicity and mood alterations, precipitated regulatory limitations and restricted prescriptions in multiple jurisdictions.

Current Market Landscape

The global acne therapeutics market was valued at approximately USD 5.1 billion in 2022, with isotretinoin products constituting a significant share prior to regulatory decelerations [2]. While branded formulations faced patent expirations, generic AVAGE gained prominence as a cost-effective alternative, effectively extending market life.

The global market for isotretinoin is projected to grow at a CAGR of 3-4% through 2030, driven by increasing prevalence of severe acne and emerging markets’ expanding healthcare access. However, the market faces headwinds due to safety concerns, stricter prescribing guidelines, and the advent of biologic therapies targeting acne pathophysiology directly.

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Market Dynamics Influencing AVAGE

Regulatory Environment and Safety Profile

The safety profile of AVAGE remains central to its market dynamics. Regulatory agencies such as the FDA and EMA impose rigorous risk management programs, including REMS (Risk Evaluation and Mitigation Strategies), to mitigate teratogenic risks [3]. These requirements restrict widespread use, often limiting prescriptions to specialized dermatologists, impacting sales volume.

In recent years, enhanced safety protocols and patient monitoring have improved the drug’s risk-benefit profile, maintaining physician confidence but concurrently constraining market expansion.

Competitive Landscape

The proliferation of alternative therapies influences AVAGE’s market share:

• Topical and systemic antibiotics: Traditional options still prescribed, but their long-term use raises antibiotic resistance concerns.
• Other systemic therapies: Newer options like hormonal agents, spironolactone, and biologics (e.g., adalimumab) pose competitive threats, especially in cases with hormonal or inflammatory components.
• Emerging Non-Pharmacological Interventions: Laser and light-based therapies are gaining traction for their efficacy and safety profiles, attracting patient preference.

Patent and Market Exclusivity

While AVAGE as a generic faces no patent barriers, the original branded formulation’s patent protections have expired historically, creating opportunities for multiple generic entrants. This intensifies price competition, likely driving down unit costs but also fostering a more accessible market.

Pricing and Reimbursement Dynamics

Generic AVAGE benefits from lower pricing, but reimbursement constraints, especially in the U.S. and Europe, influence end-user affordability. Price erosion, combined with strict prescribing criteria, impacts revenue streams.

Innovations and Formulation Developments

Formulation advancements, such as lower-dose or extended-release versions, aim to enhance safety and adherence, potentially broadening AVAGE’s market appeal.

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Financial Trajectory Analysis

Revenue Projections

• Historical Revenue: The global isotretinoin market, primarily driven by AVAGE and its equivalents, generated revenues approximating USD 0.8 billion in 2022.
• Growth Drivers: Increased awareness, expanding demographics, and favorable reimbursement policies for generics fuel incremental growth.
• Constraints: Safety concerns, regulatory restrictions, and competition suppress aggressive growth; thus, projecting modest CAGR of 2-3% through 2030.

Profitability Outlook

• Pricing Pressures: Intense generic competition leads to reduced unit prices, pressuring margins.
• Cost of Compliance: Compliance with REMS and stringent safety protocols adds operational costs, impacting profit margins.
• Market Penetration: While existing markets remain stable, expansion into emerging economies, with their increasing dermatology treatment needs, could enhance revenues.

Emerging Market Opportunities

Regions like Asia-Pacific and Latin America exhibit growing dermatological healthcare infrastructure. Market penetration here promises higher volume sales, potentially offsetting declining margins in mature markets.

Potential Disruptors

• Biologics and New Therapeutics: The entry of novel acne treatments may cannibalize AVAGE sales over time.
• Regulatory Restrictions: Future tightening of safety protocols could curtail accessibility and utilization.

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Strategic Outlook

Optimal strategies include:

• Enhanced Safety Management: Investing in education and compliance to sustain prescriber and patient confidence.
• Market Expansion: Targeting emerging markets with tailored pricing and education campaigns.
• Formulation Innovation: Developing safer, more convenient formulations to improve adherence and safety profile.
• Monitoring Competitive Innovations: Staying ahead of biologic and non-traditional therapies.

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Key Takeaways

• Market stability for AVAGE hinges on safety and regulatory adherence, despite challenges posed by safety concerns and competition.
• Generic AVAGE benefits from cost advantages, but pricing pressures persist owing to market saturation and market entry of new treatments.
• Emerging economies present significant growth opportunities due to rising dermatological treatment demands.
• Investment in formulation and safety innovation can help sustain AVAGE’s market relevance.
• Long-term growth is likely to be modest, with a CAGR of 2-3% through 2030, barring disruptive therapeutic advancements.

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FAQs

1. What factors influence the pricing of AVAGE in different markets?
Pricing is primarily affected by the degree of market competition, regulatory reimbursement policies, healthcare infrastructure, and regional safety regulations. Generic market entry exerts downward pressure on prices, while stricter safety or prescribing guidelines can limit volume.

2. How do safety concerns impact AVAGE’s market growth?
Safety concerns, especially teratogenicity, necessitate strict monitoring and prescribing restrictions under REMS programs, limiting widespread use and constraining market expansion despite the drug’s efficacy.

3. What emerging therapies threaten AVAGE’s market share?
Biologics and targeted topical agents are emerging alternatives. Although currently reserved for specific cases, their increasing efficacy and safety profiles could reduce reliance on systemic retinoids like AVAGE.

4. How can pharmaceutical companies optimize the long-term financial trajectory of AVAGE?
Focusing on formulation improvements, expanding into emerging markets, robust safety management, and strategies to facilitate patient adherence can sustain revenue streams as market dynamics evolve.

5. What role do regulatory agencies play in shaping AVAGE’s market trajectory?
Regulatory agencies influence market accessibility through safety protocols, prescription restrictions, and approval of alternative treatments. Proactive compliance and engagement are essential to mitigate adverse impacts on market presence.

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References

[1] Zaengle AE, et al. "Isotretinoin: Short-term and Long-term Effects." Journal of Dermatology, 2020.
[2] Research and Markets. "Global Acne Therapeutics Market Forecast." 2022.
[3] FDA. "Isotretinoin Prescribing Information and REMS Program." 2021.