Is there a generic for Dofetilide?

Yes. The FDA Orange Book lists 13 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, 13 generics; first approved Oct 01, 1999; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 13 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

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

Abbreviated applications

Generic (ANDA) products (13)

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

RK PHARMAANDA 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

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Oct 01, 1999

27 yr 2 mo ago

Most recent approval

Apr 15, 2022

4 yr 4 mo ago

Approvals span 1999–2022 across 14 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1393%

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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