FDA Orange Book · active-ingredient family
Escitalopram oxalate
Escitalopram oxalate is approved as 3 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ESCITALOPRAM · NDA 219130
3
Brand (NDA)
25
Generics (ANDA)
0
Listed patents
4
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESCITALOPRAMRLD | ALMATICA | NDA 219130 | — | Aug 29, 2025 | |
| LEXAPRORLD | ABBVIE | NDA 021365 | — | Nov 27, 2002 | |
| LEXAPRORLD×3 | ABBVIE | NDA 021323 | AB | Aug 14, 2002 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESCITALOPRAM OXALATE×3 | MICRO LABS | ANDA 091655 | AB | Apr 22, 2026 | |
| ESCITALOPRAM OXALATE×3 | ASCENT PHARMS INC | ANDA 215177 | AB | Jul 15, 2025 | |
| ESCITALOPRAM OXALATE×3 | AMNEAL PHARMS | ANDA 205619 | AB | May 17, 2017 | |
| ESCITALOPRAM OXALATE | MACLEODS PHARMS LTD | ANDA 202754 | AA | Mar 31, 2016 | |
| ESCITALOPRAM OXALATE×3 | PRINSTON INC | ANDA 078032 | AB | Aug 28, 2015 | |
| ESCITALOPRAM OXALATE | ANTRIM PHARMS LLC | ANDA 203967 | — | May 26, 2015 | |
| ESCITALOPRAM OXALATE×3 | NOVITIUM PHARMA | ANDA 077550 | — | May 14, 2015 | |
| ESCITALOPRAM OXALATE | CHARTWELL MOLECULAR | ANDA 090477 | AA | Jun 12, 2013 | |
| ESCITALOPRAM OXALATE×3 | AIPING PHARM INC | ANDA 077512 | — | Sep 12, 2012 | |
| ESCITALOPRAM OXALATE×3 | JUBILANT CADISTA | ANDA 202280 | AB | Sep 12, 2012 | |
| ESCITALOPRAM OXALATE×3 | ACCORD HLTHCARE | ANDA 202389 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | AUROBINDO PHARMA LTD | ANDA 090432 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | CHARTWELL RX | ANDA 078169 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | GRAVITI PHARMS | ANDA 078777 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | HIKMA PHARMS | ANDA 078766 | — | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | INVAGEN PHARMS | ANDA 078604 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | MACLEODS PHARMS LTD | ANDA 202210 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | TORRENT PHARMS LTD | ANDA 090939 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE×3 | ZYDUS LIFESCIENCES | ANDA 077734 | AB | Sep 11, 2012 | |
| ESCITALOPRAM OXALATE | HETERO LABS LTD III | ANDA 202221 | AA | Jun 12, 2012 | |
| ESCITALOPRAM OXALATE | SUN PHARMA CANADA | ANDA 079121 | — | May 03, 2012 | |
| ESCITALOPRAM OXALATE | AUROBINDO PHARMA LTD | ANDA 079062 | AA | Apr 02, 2012 | |
| ESCITALOPRAM OXALATE | AMNEAL PHARMS | ANDA 202227 | AA | Mar 14, 2012 | |
| ESCITALOPRAM OXALATE×3 | TEVA PHARMS USA | ANDA 076765 | — | Mar 14, 2012 | |
| ESCITALOPRAM OXALATE×3 | RISING | ANDA 077660 | — | Jul 31, 2007 |
Marketing exclusivity (4)
- NPPNew patient population exclusivity (3 years)
May 12, 2026
1 mo ago
- NPPNew patient population exclusivity (3 years)
May 12, 2026
1 mo ago
- NPPNew patient population exclusivity (3 years)
May 12, 2026
1 mo ago
- NPPNew patient population exclusivity (3 years)
May 12, 2026
1 mo ago
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.
Escitalopram oxalate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
