Dapsone - Generic Drug Details

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

Dapsone is the generic ingredient in two branded drugs marketed by Abbvie, Almirall, Alembic, Amneal, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Trupharma, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapsone has twenty-three patent family members in fifteen countries.

There are eight drug master file entries for dapsone. Twenty-seven suppliers are listed for this compound.

Summary for dapsone

International Patents:	23
US Patents:	1
Tradenames:	2
Applicants:	19
NDAs:	25
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	88
Patent Applications:	9,475
Drug Prices:	Drug price trends for dapsone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapsone
What excipients (inactive ingredients) are in dapsone?	dapsone excipients list
DailyMed Link:	dapsone at DailyMed

See drug prices for dapsone

Recent Clinical Trials for dapsone

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

Sponsor	Phase
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Assiut University	Phase 4
Pulmonem Inc.	Phase 3

See all dapsone clinical trials

Pharmacology for dapsone

Drug Class

Sulfone

Medical Subject Heading (MeSH) Categories for dapsone

Anti-Infective Agents

Antimalarials

Folic Acid Antagonists

Leprostatic Agents

Anatomical Therapeutic Chemical (ATC) Classes for dapsone

D10AX	Other anti-acne preparations for topical use
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J04BA	Drugs for treatment of lepra
J04B	DRUGS FOR TREATMENT OF LEPRA
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DAPSONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACZONE	Gel	dapsone	7.5%	207154	1	2017-02-13

US Patents and Regulatory Information for dapsone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Trupharma	DAPSONE	dapsone	GEL;TOPICAL	213636-001	Aug 26, 2024	AB	RX	No	No
Trupharma	DAPSONE	dapsone	GEL;TOPICAL	213907-001	Jun 6, 2023	AB	RX	No	No
Amneal	DAPSONE	dapsone	GEL;TOPICAL	209890-001	Oct 19, 2023	AB	RX	No	No
Chartwell Rx	DAPSONE	dapsone	TABLET;ORAL	204074-001	May 10, 2016		DISCN	No	No
Torrent	DAPSONE	dapsone	GEL;TOPICAL	214722-001	Feb 10, 2022	AB	RX	No	No
Nostrum Labs Inc	DAPSONE	dapsone	TABLET;ORAL	203887-002	May 6, 2016	AB	RX	No	No
Actavis Llc	DAPSONE	dapsone	TABLET;ORAL	204380-002	Mar 23, 2017	AB	RX	No	No

Expired US Patents for dapsone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	6,060,085
Abbvie	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	5,863,560
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	6,620,435
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	5,863,560
Abbvie	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	6,620,435
Abbvie	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	6,060,085

International Patents for dapsone

Country	Patent Number	Title	Estimated Expiration
Hungary	E035940
Hong Kong	1214516	局部氨苯碸和氨苯碸/阿達帕林組合物及其使用方法 (TOPICAL DAPSONE AND DAPSONE ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)
Brazil	112015011673	composições tópicas de dapsona e dapsona/adapaleno e métodos para uso das mesmas
South Korea	20150085069	국소적 댑손 및 댑손/아다팔렌 조성물 및 이의 사용 방법 (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)
Spain	2644342
Russian Federation	2015123207	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ДАПСОН И ДАПСОН/АДАПАЛЕН, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ
Japan	6285946

Dapsone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dapsone

Introduction to Dapsone

Dapsone, also known as diaminodiphenyl sulfone (DDS), is a versatile medication used in the treatment of various dermatological and infectious diseases. Its market dynamics are influenced by several factors, including expanding applications, innovative formulations, and growing demand for cost-effective antibiotics.

Market Size and Forecast

The global Dapsone market has been experiencing significant growth. As of 2021, the market size was valued at USD 436.76 million and is projected to reach USD 687.77 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.73% during the forecast period of 2023 to 2030[2].

Key Drivers of Market Growth

Rising Demand for Dermatological Treatments

Dapsone's efficacy in treating various skin disorders, such as leprosy, dermatitis herpetiformis, and acne, is a major driver of market growth. Recent research has also uncovered new potential applications for Dapsone in treating conditions like bullous pemphigoid, hidradenitis suppurativa, and granuloma annulare[3].

Increasing Incidences of Infectious Diseases

The growing prevalence of leprosy and tuberculosis, along with the emergence of drug-resistant strains, has increased the demand for Dapsone. Its antibacterial and antimicrobial properties make it an effective agent in treating these diseases[2].

Need for Cost-Effective Antibiotics

The rising need for low-cost antibiotics, especially in the face of antibiotic resistance, has made Dapsone a preferred choice. It is widely accessible and economical, making it an attractive option for many patients[2].

Market Segmentation

By Application

The Dapsone market is segmented into chemical reagents, pharmaceutical intermediates, and others. The chemical reagents segment dominated the market in 2021 due to Dapsone's widespread use as a diagnostic agent and antimalarial drug[2].

By Geography

Geographically, the market is classified into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America accounted for the highest market share in 2021, driven by the high prevalence of leprosy and other skin disorders, as well as the availability of effective therapies and generic versions of Dapsone[2].

Emerging Trends

Expansion of Applications in Dermatological Conditions

Dapsone is increasingly being used to treat a broader range of dermatological conditions, including bullous pemphigoid, hidradenitis suppurativa, and granuloma annulare. This expansion is driving increased adoption by dermatologists and other healthcare providers[3].

Emergence of Novel Formulations and Delivery Systems

Innovations in drug formulation and delivery systems are transforming the Dapsone market. Extended-release formulations, topical formulations, and combination therapies are being developed to improve patient compliance, enhance efficacy, and minimize side effects. Targeted delivery systems like nanoparticles and liposomes are also being explored[3].

Focus on Antibacterial and Antimicrobial Applications

Dapsone's antibacterial and antimicrobial properties are being leveraged to treat infectious diseases, particularly those caused by Mycobacterium leprae and Mycobacterium tuberculosis. Research is ongoing to explore its efficacy against drug-resistant strains of tuberculosis and other bacterial infections[3].

Exploration of Immunomodulatory Effects

Beyond its antimicrobial properties, Dapsone exhibits immunomodulatory effects that have therapeutic implications in various inflammatory and autoimmune conditions. It is being investigated for its potential efficacy in conditions such as autoimmune bullous diseases, vasculitis, and inflammatory skin disorders[3].

Embrace of Personalized Medicine Approaches

Advancements in pharmacogenomics and personalized medicine are enabling healthcare providers to tailor Dapsone therapy based on individual patient characteristics and genetic makeup. This approach helps in optimizing treatment outcomes and minimizing adverse drug reactions[3].

Financial Performance and Projections

The global Dapsone market was valued at approximately USD 1.2 billion in 2023 and is projected to reach USD 2.1 billion by 2032, growing at a significant rate. This growth is driven by the increasing demand for Dapsone in various therapeutic areas and the introduction of new formulations and delivery systems[4].

Key Players and Competitive Landscape

The Dapsone market is competitive, with several key players including Taro Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Zydus Cadila, Aurobindo Pharma Ltd., Cipla Ltd., Teva Pharmaceutical Industries Ltd., and Lupin Limited. These companies are focusing on product innovation, strategic partnerships, and expanding their product portfolios to maintain market share[2].

Research and Development

Significant investments in research and development are driving innovation in the Dapsone market. For instance, a study published in the journal Scientific Reports suggested that Dapsone could be a promising treatment for Parkinson’s disease by lowering inflammation and protecting against dopaminergic cell death[2].

Regional Market Analysis

North America is the leading region in the global Dapsone market, driven by the high prevalence of skin disorders and the availability of effective therapies. The region's market growth is also supported by the widespread availability of generic versions of Dapsone, making it a cost-effective option for patients[2].

Challenges and Opportunities

Challenges

• Antibiotic Resistance: The growing issue of antibiotic resistance poses a challenge to the long-term efficacy of Dapsone.
• Side Effects: Traditional oral Dapsone therapy can have side effects, which is driving the need for novel formulations and delivery systems.

Opportunities

• Expanding Applications: The potential for Dapsone to treat a broader range of dermatological and infectious diseases presents significant growth opportunities.
• Personalized Medicine: The integration of pharmacogenomics and personalized medicine approaches can enhance treatment outcomes and patient safety.

Key Takeaways

• The global Dapsone market is expected to grow significantly, driven by expanding applications, innovative formulations, and increasing demand for cost-effective antibiotics.
• North America is the leading region in the Dapsone market due to high prevalence of skin disorders and availability of effective therapies.
• Key players are focusing on product innovation, strategic partnerships, and expanding their product portfolios.
• Personalized medicine approaches and novel formulations are expected to enhance treatment outcomes and patient compliance.

FAQs

What is the current market size of the global Dapsone market?

The global Dapsone market size was valued at USD 436.76 million in 2021 and is expected to reach USD 687.77 million by 2030[2].

What are the primary applications of Dapsone?

Dapsone is primarily used as a chemical reagent, pharmaceutical intermediate, and in the treatment of various dermatological and infectious diseases[2].

Which region dominates the global Dapsone market?

North America dominates the global Dapsone market due to the high prevalence of skin disorders and the availability of effective therapies[2].

What are the emerging trends in the Dapsone market?

Emerging trends include the expansion of applications in dermatological conditions, emergence of novel formulations and delivery systems, focus on antibacterial and antimicrobial applications, exploration of immunomodulatory effects, and the embrace of personalized medicine approaches[3].

Who are the key players in the Dapsone market?

Key players include Taro Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Zydus Cadila, Aurobindo Pharma Ltd., Cipla Ltd., Teva Pharmaceutical Industries Ltd., and Lupin Limited[2].

Sources

1. Market Research Reports: Dapsone - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
2. Verified Market Research: Dapsone Market Size, Growth, Scope, Opportunities & Forecast.
3. Market Research Intellect: Unveiling the Future: Top 5 Trends in the Dapsone Market.
4. Dataintelo: Dapsone Market Research Report 2032.