Is there a generic for Dofetilide?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Dofetilide, referencing the brand TIKOSYN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dofetilide?

TIKOSYN (NDA 020931, PFIZER) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Dofetilide are approved?

Dofetilide is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Dofetilide

Dofetilide: 1 brand, 14 generics; first approved Oct 01, 1999; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 14 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

TIKOSYNRLD
PFIZERNDA 02093119993 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Generic (ANDA) products (14)

Abbreviated applications

DOFETILIDE
INNOGENIX INCANDA 21249620263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
TEVA PHARMS USAANDA 21001820223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Discontinued —
0.25MG CAPSULE ORAL Discontinued —
0.5MG CAPSULE ORAL Discontinued —
DOFETILIDE
APPCOANDA 21532320223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Discontinued —
0.25MG CAPSULE ORAL Discontinued —
0.5MG CAPSULE ORAL Discontinued —
DOFETILIDE
GRANULESANDA 21275020213 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
ACCORD HLTHCAREANDA 21333820203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
MSNANDA 21322020203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
INGENUS PHARMS LLCANDA 21241020193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Discontinued —
0.25MG CAPSULE ORAL Discontinued —
0.5MG CAPSULE ORAL Discontinued —
DOFETILIDE
PRINSTON INCANDA 21122320193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Discontinued —
0.25MG CAPSULE ORAL Discontinued —
0.5MG CAPSULE ORAL Discontinued —
DOFETILDE
AUROBINDO PHARMA LTDANDA 21074020193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
STRIDES PHARMA INTLANDA 20851920183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Discontinued —
0.25MG CAPSULE ORAL Discontinued —
0.5MG CAPSULE ORAL Discontinued —
DOFETILIDE
SUN PHARMANDA 21046620183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
BIONPHARMAANDA 20862520183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
SIGMAPHARM LABS LLCANDA 20774620183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB
DOFETILIDE
DR REDDYS LABS SAANDA 20705820163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.125MG CAPSULE ORAL Rx AB
0.25MG CAPSULE ORAL Rx AB
0.5MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Discontinued	—
0.25MG	CAPSULE	ORAL	Discontinued	—
0.5MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Discontinued	—
0.25MG	CAPSULE	ORAL	Discontinued	—
0.5MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Discontinued	—
0.25MG	CAPSULE	ORAL	Discontinued	—
0.5MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Discontinued	—
0.25MG	CAPSULE	ORAL	Discontinued	—
0.5MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Discontinued	—
0.25MG	CAPSULE	ORAL	Discontinued	—
0.5MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG	CAPSULE	ORAL	Rx	AB
0.25MG	CAPSULE	ORAL	Rx	AB
0.5MG	CAPSULE	ORAL	Rx	AB

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Oct 01, 1999

27 yr 4 mo ago

Most recent approval

Jul 29, 2026

2 mo ago

Approvals span 1999–2026 across 15 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1493%

Dofetilide: 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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