FDA Orange Book · active-ingredient family

Oxcarbazepine

Oxcarbazepine: 3 brands, 32 generics; first approved Jan 14, 2000; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 32 ANDA applications approved.

Earliest patent expiry Apr 13, 2027

Brands (NDA)

3

Generics (ANDA)

32

Listed patents

11

Next patent expiry

Apr 13, 2027

in 9 mo

Originator applications

Brand (NDA) products

SUPERNUS PHARMSNDA 20281020123 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
300MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
600MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

NOVARTISNDA 0212852001

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

NOVARTISNDA 02101420003 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (32)

MSNANDA 2090202026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

UMEDICA LABS PVTANDA 21834120263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

STERANCO HLTHCAREANDA 2202812026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

EPIC PHARMA LLCANDA 21955620263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

MACLEODS PHARMS LTDANDA 2073002025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

AUROBINDO PHARMA LTDANDA 21924120253 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
300MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
600MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

RICONPHARMA LLCANDA 21579620243 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
300MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
600MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

RUBICON RESEARCHANDA 20771720243 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

BIOCON PHARMAANDA 2182782024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

AJANTA PHARMA LTDANDA 21765920243 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
300MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
600MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

KANCHAN HLTHCAREANDA 2177822024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

HETERO LABS LTD IIIANDA 2167492023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

APOTEXANDA 21336920233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
300MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
600MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

ZYDUSANDA 21174720233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
600MG	TABLET	ORAL	Discontinued	—

ALKEM LABS LTDANDA 2131832023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

AUCTAANDA 2153322022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

BIONPHARMAANDA 2096522022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

RUBICON RESEARCHANDA 2157262022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

ANNORA PHARMAANDA 21593920223 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

PAI HOLDINGSANDA 2114202021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Discontinued	—

CHARTWELL RXANDA 2124282021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

HIKMAANDA 2011932012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Discontinued	—

AMNEAL PHARMSANDA 2029612012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

JUBILANT CADISTAANDA 09023920103 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
600MG	TABLET	ORAL	Discontinued	—

SUN PHARM INDS LTDANDA 0787342009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG/5ML	SUSPENSION	ORAL	Rx	AB

RUBICON RESEARCHANDA 07774720083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

BRECKENRIDGE PHARMANDA 07806920083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

ANI PHARMSANDA 07800520073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

TAROANDA 07780120073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

GLENMARK PHARMS LTDANDA 07780220073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

HIKMAANDA 07779520073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
600MG	TABLET	ORAL	Discontinued	—

SUN PHARM INDSANDA 07779420073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
150MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
600MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10220042	Apr 13, 2027	in 9 mo	U-2501
7910131	Apr 13, 2027	in 9 mo	U-2041
9119791	Apr 13, 2027	in 9 mo	U-2041
11896599	Apr 13, 2027	in 9 mo	Product
9855278	Apr 13, 2027	in 9 mo	Product
7722898	Apr 13, 2027	in 9 mo	Product
8821930	Apr 13, 2027	in 9 mo	Product
8617600	Apr 13, 2027	in 9 mo	Product
11166960	Apr 13, 2027	in 9 mo	Product
9370525	Apr 13, 2027	in 9 mo	Product
9351975	Apr 13, 2027	in 9 mo	Product

FDA approval span

Approval history

First approval

Jan 14, 2000

26 yr 11 mo ago

Most recent approval

May 29, 2026

1 mo ago

Approvals span 2000–2026 across 35 FDA applications.

Brand (NDA) 39%

Generic (ANDA) 3291%

Oxcarbazepine — 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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