Is there a generic for Erlotinib hydrochloride?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Erlotinib hydrochloride, referencing the brand TARCEVA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Erlotinib hydrochloride?

TARCEVA (NDA 021743, OSI PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Erlotinib hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Erlotinib hydrochloride

Erlotinib hydrochloride: 1 brand, 13 generics; first approved Nov 18, 2004; 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

TARCEVARLD

OSI PHARMSNDA 02174320043 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (13)

ERLOTINIB HYDROCHLORIDE

CHARTWELL RXANDA 20384320242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

HETERO LABS LTD VANDA 20926720243 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

EUGIA PHARMAANDA 21634220223 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Discontinued	—
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

ERLOTINIB HYDROCHLORIDE

ALEMBICANDA 21471920213 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

MSNANDA 21436620213 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

TEVA PHARMS USA INCANDA 09105920203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

ACCORD HLTHCAREANDA 21108320203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Discontinued	—
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

ERLOTINIB HYDROCHLORIDE

ZYDUS PHARMSANDA 21306520203 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

APOTEXANDA 20839620193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Discontinued	—
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

ERLOTINIB HYDROCHLORIDE

NATCO PHARMA LTDANDA 20848820193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Discontinued	—
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

ERLOTINIB HYDROCHLORIDE

SHILPAANDA 21196020193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG BASE	TABLET	ORAL	Rx	AB

ERLOTINIB HYDROCHLORIDE

SUN PHARMANDA 21030020193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Discontinued	—
EQ 100MG BASE	TABLET	ORAL	Discontinued	—
EQ 150MG BASE	TABLET	ORAL	Discontinued	—

ERLOTINIB HYDROCHLORIDE

RISINGANDA 09100220143 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 25MG BASE	TABLET	ORAL	Rx	AB
EQ 100MG BASE	TABLET	ORAL	Rx	AB
EQ 150MG 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

Nov 18, 2004

22 yr ago

Most recent approval

Sep 13, 2024

1 yr 10 mo ago

Approvals span 2004–2024 across 14 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1393%

Erlotinib 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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