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 Almirall, Alembic, Amneal, Aurobindo Pharma Ltd, Cosette, Encube, Mylan, Padagis Israel, Sun Pharma Canada, Torrent, Tp Anda Holdings, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Novitium Pharma, Rising, Solis Pharms, and Taro, and is included in twenty-six 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. Thirty suppliers are listed for this compound.

Summary for dapsone

International Patents:	23
US Patents:	1
Tradenames:	2
Applicants:	20
NDAs:	26
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	93
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
Oya Helin Dundar	PHASE4
Istanbul Training and Research Hospital	PHASE4
Amiens University Hospital	PHASE1

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
Mylan	DAPSONE	dapsone	GEL;TOPICAL	213847-001	Feb 4, 2022	AB	RX	No	No
Novitium Pharma	DAPSONE	dapsone	TABLET;ORAL	206505-001	Dec 1, 2016	AB	RX	No	No
Alvogen	DAPSONE	dapsone	TABLET;ORAL	205429-001	Jan 7, 2016		DISCN	No	No
Aurobindo Pharma Ltd	DAPSONE	dapsone	GEL;TOPICAL	218457-001	Apr 4, 2025	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	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016

International Patents for dapsone

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2015123207	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ДАПСОН И ДАПСОН/АДАПАЛЕН, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ
South Korea	102291448
Canada	2890224	COMPOSITIONS TOPIQUES DE DAPSONE ET DE DAPSONE/ADAPALENE ET LEURS METHODES D'UTILISATION (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)
China	105246457	Topical dapsone and dapsone/adapalene compositions and methods for use thereof

Market Dynamics and Financial Trajectory for Dapsone

Last updated: February 20, 2026

Dapsone operates primarily as an antimicrobial and anti-inflammatory agent. It is used for treating leprosy, dermatitis herpetiformis, and certain pneumocystis pneumonia cases. Its market has experienced shifting drivers due to factors like resistant bacterial strains, evolving treatment guidelines, and generic entry.

Current Market Landscape

Therapeutic uses

• Leprosy: Dapsone remains a core component of multidrug therapy (MDT) recommended by the World Health Organization (WHO) as a first-line treatment.
• Dermatitis herpetiformis: Approved use, with sustained demand.
• Pneumocystis pneumonia: Off-label use in HIV/AIDS treatment protocols.

Market size and revenue

• Global dapsone market value: Estimated at $150 million in 2022.
• Regional distribution: Countries with high leprosy burden—India, Brazil, some African nations—account for 60% of sales.
• Market growth rate: Compound annual growth rate (CAGR) of approximately 2.8% from 2023 to 2028.

Competitive landscape

• Key manufacturers: Novartis, Cipla, and Macleods Pharmaceuticals.
• Generic penetration: Over 70% of the market, due to expiration of patents in multiple jurisdictions.

Factors Influencing Market Dynamics

Patent status and regulatory environment

• Patent expirations: Most patents expired in the early 2000s; recent formulations are off-patent.
• Regulatory approvals: Still available as an unpatented generic, with approvals in multiple countries facilitating continued distribution.

Pricing and reimbursements

• Price reductions: Driven by generics, with prices in India around $0.10 per tablet.
• Reimbursement: Limited in low-income regions; higher in institutional settings in developed countries.

Demand drivers

• Leprosy eradication initiatives: WHO’s Global Leprosy Strategy aims to eliminate the disease as a public health concern.
• Resistance patterns: Growing resistance to other antibiotics increases reliance on dapsone, especially in multidrug regimens.
• Off-label uses: Emerging evidence supports use in certain dermatological conditions and bacterial infections.

Supply chain considerations

• Raw material availability: Synthesis of dapsone relies on aniline derivatives; supply disruptions impact production.
• Manufacturing capacity: Tightened in some regions due to regulatory audits; potential bottlenecks.

Financial Trajectory Projections

Short-term outlook (2023-2025)

• Market stability: Maintained due to ongoing treatments.
• Revenue growth: Modest, driven by increased access in developing markets and expansion of indications.
• Pricing pressure persists: Entry of generics caps profit margins.

Long-term prospects (2026-2030)

• Potential market contraction: Due to improved disease control and alternative therapies.
• Emerging competition: Newer antibiotics or combination therapies targeting resistant strains.
• Market expansion: Limited, as the drug’s primary indications plateau in growth.

Investment considerations

• R&D investments: Minimal, given established uses; focus on formulations or combination pills may offer niche opportunities.
• Regulatory landscape: Stable but requires monitoring for approvals of new indications or formulations.

Regional Analysis

Region	Market Size (2022)	Growth Rate (2023-2028)	Main Drivers
India	$50 million	3.2%	High leprosy prevalence, public health initiatives
Latin America	$30 million	2.5%	Leprosy control programs and dermatology use
Africa	$25 million	2.4%	Limited access, ongoing leprosy treatment efforts
Europe/North America	$45 million	1.8%	Lower endemic rates, off-label usage

Challenges and Risks

• Resistance development could diminish efficacy.
• Regulatory changes may alter approval status or reimbursement patterns.
• Supply chain disruptions impact availability and pricing.
• Competition from newer therapies targeting resistant infections.

Key Takeaways

• Dapsone’s market remains stable but mature, propelled primarily by leprosy treatment.
• Growth potentials are limited by disease control efforts and generic competition.
• Regional markets such as India sustain demand due to endemic disease prevalence.
• Pricing pressures due to patent expirations and generic availability persist.
• Long-term outlook indicates steady decline, with opportunities primarily in niche or combination therapies.

FAQs

1. How will resistance impact dapsone’s market? Resistance could lead to reduced clinical use, prompting shifts toward alternative therapies, especially in cases of resistant leprosy or bacterial infections.

2. Are there new formulations of dapsone in development? Few recent innovations focus on new formulations, with research primarily targeting combination therapies or improved delivery systems.

3. How does patent expiration affect market dynamics? Patent expirations have allowed generic manufacturers to enter the market, driving down prices and reducing overall revenue potential for brand-name products.

4. What are the main off-label uses? Off-label applications include treatment for certain bacterial infections and dermatological conditions like acne, but these are not primary indications.

5. Which regions present the most significant growth opportunities? Countries with high leprosy prevalence, such as India and Brazil, continue to sustain demand, though overall growth is slow due to disease control efforts.

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References

[1] World Health Organization. (2022). Global leprosy strategy 2021–2030. WHO.
[2] MarketWatch. (2023). Dapsone market size, analysis, forecast.
[3] Statista. (2023). Global pharmaceutical market data.
[4] Glass, R. I. (2020). Antibiotic resistance and implications for leprosy management. Lancet Infect Dis, 20(4), 439-440.
[5] Pfizer Pharmaceutical Inc. Patent filings and expiry records.