Isotretinoin - Generic Drug Details

What are the generic drug sources for isotretinoin and what is the scope of freedom to operate?

Isotretinoin is the generic ingredient in nine branded drugs marketed by Sun Pharm Inds Inc, Sun Pharm, Hoffmann La Roche, Mylan Pharms Inc, Teva Pharms Usa, Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, Zydus Pharms, Sun Pharm Inds Ltd, and Dr Reddys Labs Ltd, and is included in sixteen NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Isotretinoin has seventeen patent family members in nine countries.

There are thirteen drug master file entries for isotretinoin. Twelve suppliers are listed for this compound.

Summary for isotretinoin

International Patents:	17
US Patents:	2
Tradenames:	9
Applicants:	12
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	146
Patent Applications:	8,157
Drug Prices:	Drug price trends for isotretinoin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for isotretinoin
What excipients (inactive ingredients) are in isotretinoin?	isotretinoin excipients list
DailyMed Link:	isotretinoin at DailyMed

See drug prices for isotretinoin

Recent Clinical Trials for isotretinoin

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

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	Phase 2
Chang Gung Memorial Hospital	Phase 1/Phase 2
South Valley University	N/A

See all isotretinoin clinical trials

Pharmacology for isotretinoin

Drug Class

Retinoid

Medical Subject Heading (MeSH) Categories for isotretinoin

Dermatologic Agents

Teratogens

Anatomical Therapeutic Chemical (ATC) Classes for isotretinoin

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10BA	Retinoids for treatment of acne
D10B	ANTI-ACNE PREPARATIONS FOR SYSTEMIC USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for ISOTRETINOIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSORICA	Capsules	isotretinoin	25 mg	021951	1	2016-05-16
ABSORICA	Capsules	isotretinoin	35 mg	021951	1	2015-11-25
ABSORICA	Capsules	isotretinoin	10 mg	021951	1	2013-06-20
ABSORICA	Capsules	isotretinoin	20 mg	021951	1	2013-01-07
ABSORICA	Capsules	isotretinoin	40 mg	021951	1	2012-12-31

US Patents and Regulatory Information for isotretinoin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-002	Nov 5, 2019		RX	Yes	No	9,750,711		Y
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-001	Aug 29, 2023	AB1	RX	No	No
Teva Pharms Usa	CLARAVIS	isotretinoin	CAPSULE;ORAL	076135-002	Apr 11, 2003	AB1	RX	No	No
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-003	May 7, 1982		DISCN	Yes	No
Dr Reddys Labs Ltd	ZENATANE	isotretinoin	CAPSULE;ORAL	202099-001	Mar 25, 2013	AB1	RX	No	No
Zydus Pharms	ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	211568-004	Aug 29, 2023	AB1	RX	No	No
Sun Pharm	ABSORICA LD	isotretinoin	CAPSULE;ORAL	211913-006	Nov 5, 2019		RX	Yes	Yes	9,750,711		Y

Expired US Patents for isotretinoin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,200,647
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-004	May 25, 2012	8,367,102
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-002	May 25, 2012	8,367,102
Hoffmann La Roche	ACCUTANE	isotretinoin	CAPSULE;ORAL	018662-004	Mar 28, 1983	4,464,394*PED
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	8,952,064
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-004	May 25, 2012	9,089,534
Sun Pharm Inds Inc	ABSORICA	isotretinoin	CAPSULE;ORAL	021951-003	May 25, 2012	7,435,427

International Patents for isotretinoin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016016742
World Intellectual Property Organization (WIPO)	2016051288
Mexico	2017004312	COMPOSICION FARMACEUTICA ORAL DE BAJA DOSIS DE ISOTRETINOINA. (LOW DOSE ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN.)
European Patent Office	3174601
Russian Federation	2017106013
South Africa	201700843	ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN
Canada	2963206

Isotretinoin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isotretinoin

Market Size and Growth

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

By 2028, the market is expected to expand to $1.60 billion, maintaining a CAGR of 5.6%[1]. Long-term projections indicate that the market will continue to grow, reaching $1,708.48 million by 2031 at a CAGR of 4% from 2024 to 2031[3].

Drivers of Market Growth

Several factors are driving the growth of the isotretinoin market:

Prevalence of Severe Acne

The increasing incidence of severe acne, particularly among young adults, is a significant driver. Acne vulgaris affects approximately 85% of young adults aged 12 to 25, making acne treatment methods and pharmaceuticals highly demanded[4].

Effectiveness and Safety

Isotretinoin's demonstrated efficacy in treating severe acne that does not respond to other therapies is a key factor. Improvements in medication formulations and administration methods have enhanced its safety and effectiveness profiles[3].

Skincare Trends and Awareness

Growing awareness and trends in skincare, along with a broader emphasis on comprehensive skincare solutions, are contributing to the market's expansion. The psychological impact of acne and the importance of prompt, efficient treatment are also gaining recognition[3].

Regulatory Approvals and Dermatology Visits

Regulatory approvals and increased dermatology visits have further boosted the market. In regions like the UK, isotretinoin can only be prescribed by experienced consultant dermatologists, ensuring careful monitoring and use[4].

Regional Market Analysis

The isotretinoin market is segmented across various regions, each with its own growth dynamics:

North America

North America is the largest contributor to the global isotretinoin market, driven by a well-developed healthcare infrastructure, favorable government regulations, and high R&D investments. The region is expected to grow at a CAGR of 5.26% during the forecast period[4].

Europe

Europe is anticipated to grow at a CAGR of 3.84%, driven by rising cases of genetic disorders and skin cancer, a rapidly developing healthcare sector, and increasing healthcare spending. Key players in the region are innovating and driving market growth[4].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market, driven by the emergence of several market players such as Sun Pharma and Dr. Reddy's Laboratories in India. The region is witnessing high demand for isotretinoin drugs, fueled by increasing awareness and funding from investors[4].

Distribution Channels and Accessibility

The market expansion is also supported by the better accessibility of isotretinoin through diverse distribution channels. This includes pharmacies, hospitals, and online platforms, making the drug more readily available to a wider population[3].

Technological Advancements and R&D

Research and development are crucial in the isotretinoin market. Technological advancements, generic drug innovations, and improved formulations are expected to drive growth in the forecast period. These advancements aim to mitigate side effects and enhance the drug's efficacy[1].

Challenges and Side Effects

Despite its effectiveness, isotretinoin is associated with several side effects, including congenital disabilities if taken by pregnant women, and a positive correlation with the development of Inflammatory Bowel Disease, Ulcerative Colitis, and Crohn’s Disease. These side effects have led to numerous personal injury lawsuits against manufacturers like Roche[2].

Legal and Regulatory Landscape

The legal landscape surrounding isotretinoin is complex, with many lawsuits filed against manufacturers. For instance, Roche pulled Accutane from the U.S. market in 2010, and several verdicts have included awards exceeding $10 million, though many are later reduced or overturned on appeal[2].

Key Takeaways

• The isotretinoin market is expected to grow significantly, driven by the prevalence of severe acne, improved formulations, and increasing awareness.
• North America is the largest market, while the Asia-Pacific region is the fastest-growing.
• Technological advancements and R&D are critical for market growth.
• Despite its efficacy, isotretinoin is associated with serious side effects, leading to legal challenges.

FAQs

Q: What is the current market size of the isotretinoin drugs market? A: As of 2023, the isotretinoin drugs market size was valued at approximately $1.22 billion[1].

Q: What is the projected growth rate of the isotretinoin market? A: The market is expected to grow at a CAGR of 5.6% from 2023 to 2028 and at a CAGR of 4% from 2024 to 2031[1][3].

Q: Which region is the largest contributor to the global isotretinoin market? A: North America is the largest contributor to the global isotretinoin market, driven by a well-developed healthcare infrastructure and high R&D investments[4].

Q: What are the main side effects associated with isotretinoin? A: Isotretinoin is associated with side effects including congenital disabilities, Inflammatory Bowel Disease, Ulcerative Colitis, and Crohn’s Disease[2].

Q: Why was Accutane pulled from the U.S. market? A: Accutane was pulled from the U.S. market in 2010 by Roche, partly due to the numerous lawsuits related to its side effects[2].

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. Straits Research. Isotretinoin Drugs Market Size, Share, Analysis and Forecast to 2031.