FDA Orange Book

Generic for Oxtellar XR

Oxtellar XR contains oxcarbazepine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Oxtellar XR is oxcarbazepine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Oxtellar XR products in the Orange Book

Oxtellar XR products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, extended release, oral	150MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	300MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	600MG	Marketed (Rx)	AB	3	AB

NDA 202810, held by SUPERNUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic oxcarbazepine

Approved generic versions of Oxtellar XR
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	213369	AB (A-rated, therapeutically equivalent)	July 13, 2023	150MG, 300MG, 600MG
AJANTA PHARMA LTD	217659	AB (A-rated, therapeutically equivalent)	February 22, 2024	150MG, 300MG, 600MG
RICONPHARMA LLC	215796	AB (A-rated, therapeutically equivalent)	November 22, 2024	150MG, 300MG, 600MG

Oxtellar XR patents

Patents listed for Oxtellar XR
Patent	Expires	Covers	Use code	NDA
10220042	April 13, 2027	Method of use	U-2501	202810
7910131	April 13, 2027	Method of use	U-2041	202810
9119791	April 13, 2027	Method of use	U-2041	202810
11896599	April 13, 2027	Drug product	None	202810
9855278	April 13, 2027	Drug product	None	202810
7722898	April 13, 2027	Drug product	None	202810
8821930	April 13, 2027	Drug product	None	202810
8617600	April 13, 2027	Drug product	None	202810
11166960	April 13, 2027	Drug product	None	202810
9370525	April 13, 2027	Drug product	None	202810
9351975	April 13, 2027	Drug product	None	202810

Oxtellar XR NDC codes

Questions

Is there a generic for Oxtellar XR?

Yes. The generic name for Oxtellar XR is oxcarbazepine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Oxtellar XR?

The active ingredient in Oxtellar XR is oxcarbazepine, per the FDA Orange Book.

When does the Oxtellar XR patent expire?

The last patent listed for Oxtellar XR in the Orange Book expires April 13, 2027. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.