Is there a generic for Dapsone?

Yes. The FDA Orange Book lists 27 approved generic (ANDA) applications for Dapsone, referencing the brand ACZONE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dapsone?

ACZONE (NDA 207154, ALMIRALL) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Dapsone?

The Orange Book lists 1 patent against Dapsone products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Dapsone are approved?

Dapsone is approved in the following dosage forms: gel, tablet.

FDA Orange Book · active-ingredient family

Dapsone

Dapsone: 2 brands, 27 generics; first approved Jul 07, 2005; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 27 ANDA applications approved.

Earliest patent expiry Nov 18, 2033

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 18, 2033

in 7 yr 5 mo

Brand (NDA) products

Originator applications

ACZONERLDRS
ALMIRALLNDA 2071542016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
ACZONERLDRS
ALMIRALLNDA 0217942005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Generic (ANDA) products (27)

Abbreviated applications

DAPSONE
MACLEODS PHARMS LTDANDA 21833520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
DAPSONE
ALEMBICANDA 2134142026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
ZYDUS LIFESCIENCESANDA 22010320262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
DAPSONE
AUROBINDO PHARMA LTDANDA 2184572025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
TP ANDA HOLDINGSANDA 2136362024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
ZYDUS LIFESCIENCESANDA 2140192024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
CHARTWELL RXANDA 2126572023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Discontinued —
DAPSONE
CHARTWELL RXANDA 2150872023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Discontinued —
DAPSONE
ALEMBICANDA 2157182023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
AMNEALANDA 2098902023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
ENCUBEANDA 2123832023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
RISINGANDA 20716520232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Rx AB
25MG TABLET ORAL Rx AB
DAPSONE
TP ANDA HOLDINGSANDA 2139072023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
AMNEALANDA 2127012023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
COSETTE PHARMS NCANDA 2101782022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
TORRENTANDA 2147222022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
MYLANANDA 2138472022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
SUN PHARMA CANADAANDA 2101912019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
7.5% GEL TOPICAL Rx AB
DAPSONE
TAROANDA 20943020192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
DAPSONE
SUN PHARMA CANADAANDA 2095062017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% GEL TOPICAL Rx AB
DAPSONE
ACTAVIS LLCANDA 20438020172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
DAPSONE
NOVITIUM PHARMAANDA 20650520162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
DAPSONE
CHARTWELL RXANDA 20407420162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
DAPSONE
SOLIS PHARMSANDA 20388720162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
100MG TABLET ORAL Rx AB
DAPSONE
ALVOGENANDA 20542920162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Discontinued —
100MG TABLET ORAL Discontinued —
DAPSONERLD
EVEREST LIFE SCIANDA 086841—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG TABLET ORAL Rx AB
DAPSONERLD
EVEREST LIFE SCIANDA 086842—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	AB
25MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
7.5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11273132	Nov 18, 2033	in 7 yr 5 mo	Product

Approval history

FDA approval span

First approval

Jul 07, 2005

21 yr 5 mo ago

Most recent approval

Jul 08, 2026

27 d ago

Approvals span 2005–2026 across 29 FDA applications.

Brand (NDA) 27%

Generic (ANDA) 2793%

Dapsone: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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