Is there a generic for Naratriptan hydrochloride?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Naratriptan hydrochloride, referencing the brand AMERGE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Naratriptan hydrochloride?

AMERGE (NDA 020763, GLAXOSMITHKLINE LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Naratriptan hydrochloride are approved?

Naratriptan hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Naratriptan hydrochloride

Naratriptan hydrochloride: 1 brand, 9 generics; first approved Feb 10, 1998; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 9 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

AMERGERLD

GLAXOSMITHKLINE LLCNDA 02076319982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (9)

NARATRIPTAN

AUROBINDO PHARMA USAANDA 20243120122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Discontinued	—
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—

NARATRIPTAN

ORBION PHARMSANDA 09144120122 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB

NARATRIPTAN

APOTEX CORPANDA 09137320112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Discontinued	—
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—

NARATRIPTAN

HERITAGEANDA 20050220112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB

NARATRIPTAN

SUN PHARM INDS LTDANDA 0915522011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—

NARATRIPTAN

PADAGIS USANDA 09132620102 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Discontinued	—
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—

NARATRIPTAN

ANI PHARMSANDA 07875120102 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Discontinued	—
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—

NARATRIPTAN

CHARTWELL RXANDA 09028820102 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Discontinued	—
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—

NARATRIPTAN

HIKMAANDA 09038120102 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE	TABLET	ORAL	Rx	AB
EQ 2.5MG BASE	TABLET	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

Feb 10, 1998

28 yr 10 mo ago

Most recent approval

May 31, 2012

14 yr 4 mo ago

Approvals span 1998–2012 across 10 FDA applications.

Brand (NDA) 110%

Generic (ANDA) 990%

Naratriptan hydrochloride — 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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