ACCUTANE Drug Patent Profile

Which patents cover Accutane, and what generic alternatives are available?

Accutane is a drug marketed by Hoffmann La Roche and is included in one NDA.

The generic ingredient in ACCUTANE is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accutane

A generic version of ACCUTANE was approved as isotretinoin by AMNEAL PHARMS NY on September 29^th, 2017.

Summary for ACCUTANE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	34
Patent Applications:	7,956
DailyMed Link:	ACCUTANE at DailyMed

Recent Clinical Trials for ACCUTANE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vyne Therapeutics Inc.	Phase 4
Edward Lain, MD	Phase 4
Children's Oncology Group	Phase 2

See all ACCUTANE clinical trials

US Patents and Regulatory Information for ACCUTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-002	May 7, 1982		DISCN	Yes	No
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983		DISCN	Yes	No
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982		DISCN	Yes	No

Expired US Patents for ACCUTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982

International Patents for ACCUTANE

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	170921
Yugoslavia	40319
Portugal	67600	NOVEL 1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES

ACCUTANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isotretinoin (Accutane)

Introduction

Isotretinoin, commonly known by the brand name Accutane, is a powerful medication primarily used to treat severe cases of acne. Despite its effectiveness, the drug has been embroiled in controversy due to its side effects and subsequent legal battles. Here, we delve into the market dynamics and financial trajectory of isotretinoin.

Market Size and Growth

The isotretinoin drugs market has experienced significant growth in recent years. As of 2023, the market size was valued at $1.22 billion and is projected to grow to $1.29 billion in 2024, with a compound annual growth rate (CAGR) of 5.5%[1][3].

By 2028, the market is expected to reach $1.60 billion, maintaining a CAGR of 5.6%. This growth is driven by increasing awareness and skincare trends, expansion in emerging markets, the rising incidence of acne, an aging population, and a focus on mental health and well-being[1].

Segmentation of the Market

The isotretinoin market is segmented based on form, indication type, and distribution channel.

By Form

The market includes capsules and injections, with capsules being the dominant form due to their ease of administration and patient compliance[1].

By Indication Type

Isotretinoin is used for various indications, including:

• Severe Acne: The primary and most common use.
• Neuroblastoma
• Cutaneous T-Cell Lymphoma
• Harlequin Ichthyosis
• Xeroderma Pigmentosum
• Fibrodysplasia Ossificans Progressiva
• Squamous Cell Skin Cancers
• Other Indication Types

Severe acne remains the largest segment due to the drug's high efficacy in treating this condition[1].

By Distribution Channel

The market is segmented into:

• Hospitals Pharmacies
• Retail Pharmacies
• Online Pharmacies

Retail and online pharmacies are expected to witness lucrative growth due to the increasing demand for over-the-counter (OTC) drugs and the convenience of online shopping[1][4].

Historical Context and Withdrawal from the Market

Accutane, the brand name for isotretinoin developed by Hoffmann-La Roche, was initially approved by the FDA in 1982. Despite its effectiveness in treating severe acne, the drug faced significant criticism and legal challenges due to its side effects, including inflammatory bowel disease (IBD) and ulcerative colitis.

In 2010, Roche withdrew Accutane from the U.S. market, citing financial concerns and the mounting cost of defending lawsuits. However, the drug remains available under other brand names internationally[2].

Legal Battles and Financial Implications

The withdrawal of Accutane from the U.S. market was largely due to the numerous lawsuits filed against Roche. These lawsuits alleged that Accutane caused severe gastrointestinal problems, including IBD and ulcerative colitis. Some verdicts were substantial, with awards exceeding $10 million, although many were later reduced or overturned on appeal[2].

For example, in 2010, Roche faced a $25 million verdict in a case where the plaintiff developed IBD after taking Accutane. While some of these verdicts were overturned, they significantly impacted the financial trajectory of the drug[2].

Competitive Landscape

The isotretinoin market is competitive, with several key players:

• F. Hoffmann-La Roche Ltd.
• Abbott Laboratories
• Viatris Inc.
• Teva Pharmaceutical Industries Ltd.
• Bausch Health Companies Inc.

These companies are involved in research and development, technological advancements, and the introduction of generic and improved formulations, which continue to drive market growth[1].

Trends and Drivers

Several trends and drivers are influencing the isotretinoin market:

• Research and Development: Continuous improvements in medication formulations and delivery systems.
• Technological Advancements: Advances in dermatology and the development of more efficient treatments.
• Generic Drug Innovations: The introduction of generic versions of isotretinoin, which increases accessibility.
• Growing Awareness: Increased awareness of the negative effects of acne on quality of life and mental health.
• Expansion in Emerging Markets: Growing demand in emerging economies due to increased access to dermatological care[1][3].

Financial Performance

Despite the challenges faced by Accutane in the U.S. market, the global isotretinoin market continues to grow. The financial performance of key players is influenced by the market's overall growth, driven by the increasing incidence of acne and the effectiveness of isotretinoin in treating severe cases.

The market's projected growth to $1.60 billion by 2028 and $1.708 billion by 2031 indicates a robust financial trajectory, despite past legal and regulatory hurdles[1][3].

Key Takeaways

• The isotretinoin market is growing, driven by increasing awareness, skincare trends, and the effectiveness of the drug.
• The market is segmented by form, indication type, and distribution channel, with severe acne being the primary indication.
• Legal battles and side effects led to the withdrawal of Accutane from the U.S. market but did not halt global sales.
• Key players are investing in research and development, technological advancements, and generic innovations.
• The market is expected to continue growing, reaching $1.60 billion by 2028 and $1.708 billion by 2031.

FAQs

What is the primary use of isotretinoin?

Isotretinoin is primarily used to treat severe cases of acne that are resistant to other treatments.

Why was Accutane withdrawn from the U.S. market?

Accutane was withdrawn from the U.S. market in 2010 due to financial concerns and the mounting cost of defending lawsuits related to its side effects, such as inflammatory bowel disease (IBD) and ulcerative colitis.

What are the key drivers of the isotretinoin market?

The key drivers include growing awareness and skincare trends, expansion in emerging markets, increasing incidence of acne, an aging population, and a focus on mental health and well-being.

Who are the major players in the isotretinoin market?

Major players include F. Hoffmann-La Roche Ltd., Abbott Laboratories, Viatris Inc., Teva Pharmaceutical Industries Ltd., and Bausch Health Companies Inc.

What is the projected market size of isotretinoin by 2031?

The isotretinoin market is expected to reach $1.708 billion by 2031, growing at a CAGR of 4% from 2024 to 2031[3].

Sources

1. The Business Research Company. Global Isotretinoin Drugs Market Report 2024.
2. Miller and Zois. Accutane Lawsuits: The Story with a 2024 Update.
3. Market Research Intellect. Isotretinoin Drugs Market Size, Share | Industry Research Report 2031.
4. Fortune Business Insights. Acne Treatment Market Size, Trends | Revenue Share [2032].
5. Sills Cummis & Gross P.C. In re Accutane Litigation: A Victory for Pharmaceutical Companies on Choice of Law and Label Warnings.