Viewing data from:

OXCARBAZEPINE

ANDA

OXCARBAZEPINE | A213369 | APOTEX INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: OXTELLAR XR(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
SUPERNUS PHARMACEUTICALS, INC. v. APOTEX INC. et al 3:2022cv00322 10 patentsANDA 213369oxcarbazepine	D.N.J.	2022-01-24	Terminated 2022-08-01	—
SUPERNUS PHARMACEUTICALS, INC. v. APOTEX INC. et al 3:2020cv07870 9 patentsANDA 213369oxcarbazepine	D.N.J.	2020-06-26	Terminated 2023-06-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain19 active DMFs10 inactive

18 active API suppliers hold Drug Master Files for this ingredient.

TARO PHARMACEUTICAL INDUSTRIES LTDOXCARBAZEPINE MICRONIZED

DMF 163392002

JUBILANT BIOSYS LTDOXCARBAZEPINE USP

DMF 164302003

ARCHIMICA SPAOXCARBAZEPINE

DMF 165882003

FIS FABBRICA ITALIANA SINTETICI SPAOXCARBAZEPINE

DMF 165972003

SIGNA SA DE CVOXCARBAZEPINE USP

DMF 179882005

SUN PHARMACEUTICAL INDUSTRIES LTDOXCARBAZEPINE USP

DMF 185042005

JUBILANT PHARMOVA LTDOXCARBAZEPINE CO-PRECIPITATE

DMF 209382007

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)OXCARBAZEPINE USP

DMF 231912009

CTX LIFE SCIENCES PVT LTDOXCARBAZEPINE

DMF 233532009

DASAMI LAB PRIVATE LTDOXCARBAZEPINE USP

DMF 315252017

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDOXCARBAZEPINE

DMF 329992018

MSN LIFE SCIENCES PRIVATE LTDOXCARBAZEPINE USP

DMF 332742018

ZAKLADY FARMACEUTYCZNE POLPHARMA SAOXCARBAZEPINE

DMF 344182019

AURORE LIFE SCIENCES PRIVATE LTDOXCARBAZEPINE USP

DMF 344842019

DASAMI LAB PRIVATE LTDOXCARBAZEPINE USP (PROCESS-II)

DMF 351902020

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDOXCARBAZEPINE

DMF 372032022

AMI LIFESCIENCES PRIVATE LTDOXCARBAZEPINE

DMF 380172023

MICRO LABS LTDOXCARBAZEPINE USP

DMF 387942023

STHREE CHEMICALS PRIVATE LTDOXCARBAZEPINE USP

DMF 410302024

FARCHEMIA SRLInactiveOXCARBAZEPINE

DMF 158892002

BASF ORGAMOL PHARMA SOLUTIONS SAInactiveOXCARBAZEPINE

DMF 170292004

TRIFARMA SPAInactiveOXCARBAZEPINE

DMF 174882004

DR REDDYS LABORATORIES LTDInactiveOXCARBAZEPINE

DMF 183812005

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEInactiveOXCARBAZEPINE

DMF 183832005

FABBRICA ITALIANA SINTETICI SPAInactiveOXCARBAZEPINE

DMF 185212005

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveOXCARBAZEPINE

DMF 205162007

MATRIX LABORATORIES LTDInactiveOXCARBAZEPINE

DMF 223702008

KONDUSKAR LABORATORIES PVT LTDInactiveOXCARBAZEPINE USP

DMF 260272012

CTX LIFESCIENCES PVT LTDInactiveOXCARBAZEPINE USP

DMF 341022019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 21, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 13, 2023

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 13, 2023

#003 — 600MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 13, 2023