Is there a generic for Dapsone?

Yes. The FDA Orange Book lists 25 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 is approved as 2 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACZONE · NDA 207154

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel, tablet

Product	Applicant	Application	TE	Approved
ACZONERLD	ALMIRALL	NDA 207154	AB	Feb 24, 2016
ACZONERLD	ALMIRALL	NDA 021794	AB	Jul 07, 2005

Generic (ANDA) products (25)

Product	Applicant	Application	TE	Approved
DAPSONE×2	ZYDUS LIFESCIENCES	ANDA 220103	AB	Feb 26, 2026
DAPSONE	AUROBINDO PHARMA LTD	ANDA 218457	AB	Apr 04, 2025
DAPSONE	TP ANDA HOLDINGS	ANDA 213636	AB	Aug 26, 2024
DAPSONE	ZYDUS LIFESCIENCES	ANDA 214019	AB	May 08, 2024
DAPSONE	CHARTWELL RX	ANDA 212657	—	Nov 01, 2023
DAPSONE	CHARTWELL RX	ANDA 215087	—	Oct 31, 2023
DAPSONE	ALEMBIC	ANDA 215718	AB	Oct 27, 2023
DAPSONE	AMNEAL	ANDA 209890	AB	Oct 19, 2023
DAPSONE	ENCUBE	ANDA 212383	AB	Oct 13, 2023
DAPSONE×2	RISING	ANDA 207165	AB	Jul 20, 2023
DAPSONE	TP ANDA HOLDINGS	ANDA 213907	AB	Jun 06, 2023
DAPSONE	AMNEAL	ANDA 212701	AB	May 31, 2023
DAPSONE	COSETTE PHARMS NC	ANDA 210178	AB	Mar 31, 2022
DAPSONE	TORRENT	ANDA 214722	AB	Feb 10, 2022
DAPSONE	MYLAN	ANDA 213847	AB	Feb 04, 2022
DAPSONE	SUN PHARMA CANADA	ANDA 210191	AB	Jun 26, 2019
DAPSONE×2	TARO	ANDA 209430	—	Mar 01, 2019
DAPSONE	SUN PHARMA CANADA	ANDA 209506	AB	Oct 16, 2017
DAPSONE×2	ACTAVIS LLC	ANDA 204380	AB	Mar 23, 2017
DAPSONE×2	NOVITIUM PHARMA	ANDA 206505	AB	Dec 01, 2016
DAPSONE×2	CHARTWELL RX	ANDA 204074	—	May 10, 2016
DAPSONE×2	SOLIS PHARMS	ANDA 203887	AB	May 06, 2016
DAPSONE×2	ALVOGEN	ANDA 205429	—	Jan 07, 2016
DAPSONERLD	EVEREST LIFE SCI	ANDA 086841	AB	Approved Prior to Jan 1, 1982
DAPSONERLD	EVEREST LIFE SCI	ANDA 086842	AB	Approved Prior to Jan 1, 1982

Listed patents (1)

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 6 mo	Product

Dapsone — frequently asked questions

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

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