FDA Orange Book · active-ingredient family
Escitalopram oxalate
Escitalopram oxalate: 3 brands, 25 generics; first approved Aug 14, 2002; generic available.
Generic available4 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
25
Listed patents
0
Presentations
66
Brand (NDA) products
Originator applications
- ALMATICANDA 2191302025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15MG BASE CAPSULE ORAL Rx — - LEXAPRORLDABBVIENDA 0213652002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Discontinued — - LEXAPRORLDABBVIENDA 02132320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (25)
Abbreviated applications
- ESCITALOPRAM OXALATEMICRO LABSANDA 09165520263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEASCENT PHARMS INCANDA 21517720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEAMNEAL PHARMSANDA 20561920173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEMACLEODS PHARMS LTDANDA 2027542016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Rx AA - ESCITALOPRAM OXALATEPRINSTON INCANDA 07803220153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEANTRIM PHARMS LLCANDA 2039672015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Discontinued — - ESCITALOPRAM OXALATENOVITIUM PHARMAANDA 07755020153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — - ESCITALOPRAM OXALATECHARTWELL MOLECULARANDA 0904772013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Rx AA - ESCITALOPRAM OXALATEAIPING PHARM INCANDA 07751220123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — - ESCITALOPRAM OXALATEJUBILANT CADISTAANDA 20228020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEACCORD HLTHCAREANDA 20238920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEAUROBINDO PHARMA LTDANDA 09043220123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATECHARTWELL RXANDA 07816920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEGRAVITI PHARMSANDA 07877720123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEHIKMA PHARMSANDA 07876620123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — - ESCITALOPRAM OXALATEINVAGEN PHARMSANDA 07860420123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEMACLEODS PHARMS LTDANDA 20221020123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATETORRENT PHARMS LTDANDA 09093920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATEZYDUS LIFESCIENCESANDA 07773420123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - ESCITALOPRAM OXALATERSHETERO LABS LTD IIIANDA 2022212012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Rx AA - ESCITALOPRAM OXALATESUN PHARMA CANADAANDA 0791212012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Discontinued — - ESCITALOPRAM OXALATEAUROBINDO PHARMA LTDANDA 0790622012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Rx AA - ESCITALOPRAM OXALATEAMNEAL PHARMSANDA 2022272012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/5ML SOLUTION ORAL Rx AA - ESCITALOPRAM OXALATETEVA PHARMS USAANDA 07676520123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 10MG BASE TABLET ORAL Discontinued — EQ 20MG BASE TABLET ORAL Discontinued — - ESCITALOPRAM OXALATERISINGANDA 07766020073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE CAPSULE ORAL Discontinued — EQ 10MG BASE CAPSULE ORAL Discontinued — EQ 20MG BASE CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPPNew patient population exclusivity (3 years)
3 mo ago
- NPPNew patient population exclusivity (3 years)
3 mo ago
- NPPNew patient population exclusivity (3 years)
3 mo ago
- NPPNew patient population exclusivity (3 years)
3 mo ago
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
24 yr 4 mo ago
Most recent approval
4 mo ago
Approvals span 2002–2026 across 28 FDA applications.
Brand (NDA) 311%
Generic (ANDA) 2589%
Escitalopram oxalate: 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.
