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)
1
Generics (ANDA)
13
Listed patents
0
Presentations
41
Brand (NDA) products
Originator applications
- TARCEVARLDOSI PHARMSNDA 02174320043 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 —
Generic (ANDA) products (13)
Abbreviated applications
- ERLOTINIB HYDROCHLORIDECHARTWELL 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 HYDROCHLORIDEHETERO 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 HYDROCHLORIDEEUGIA 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 HYDROCHLORIDEALEMBICANDA 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 HYDROCHLORIDEMSNANDA 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 HYDROCHLORIDETEVA 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 HYDROCHLORIDEACCORD 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 HYDROCHLORIDEZYDUS 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 HYDROCHLORIDEADAPTISANDA 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 HYDROCHLORIDEAPOTEXANDA 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 HYDROCHLORIDENATCO 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 HYDROCHLORIDESUN 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 HYDROCHLORIDERISINGANDA 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
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
22 yr 3 mo ago
Most recent approval
2 yr 1 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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