Viewing data from:

ESLICARBAZEPINE ACETATE

ANDA

ESLICARBAZEPINE ACETATE | A211238 | DR REDDYS LABORATORIES LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: APTIOM(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BIAL - PORTELA & CA S.A. et al v. Dr. Reddy's Laboratories, Ltd. et al 1:2018cv00341 6 patentsANDA 211238Eslicarbazepine Acetate	D. Del.	2018-03-02	Terminated 2021-12-08	—

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

API Supply Chain18 active DMFs3 inactive

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

BIAL PORTELA AND CA SAESLICARBAZEPINE ACETATE

DMF 266222012

JUBILANT BIOSYS LTDESLICARBAZEPINE ACETATE

DMF 269272013

CTX LIFE SCIENCES PVT LTDESLICARBAZEPINE ACETATE

DMF 302222016

LUPIN MANUFACTURING SOLUTIONS LTDESLICARBAZEPINE ACETATE

DMF 315002017

DR REDDYS LABORATORIES LTDESLICARBAZEPINE ACETATE

DMF 317582017

DELMAR CHEMICALS INCESLICARBAZEPINE ACETATE

DMF 317912017

DASAMI LAB PRIVATE LTDESLICARBAZEPINE ACETATE

DMF 318962017

MSN LIFE SCIENCES PRIVATE LTDESLICARBAZEPINE ACETATE

DMF 327212018

COHANCE LIFESCIENCES LTDESLICARBAZEPINE ACETATE

DMF 330282018

APITORIA PHARMA PRIVATE LTDESLICARBAZEPINE ACETATE

DMF 350942020

DASAMI LAB PRIVATE LTDESLICARBAZEPINE ACETATE (PROCESS-II)

DMF 354722021

ALKEM LABORATORIES LTDESLICARBAZEPINE ACETATE

DMF 380462025

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDESLICARBAZEPINE ACETATE

DMF 381492023

AMI LIFESCIENCES PRIVATE LTDESLICARBAZEPINE ACETATE

DMF 383092023

INNER MONGOLIA JINGDONG PHARMACEUTICAL CO LTDESLICARBAZEPINE ACETATE

DMF 390712023

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDESLICARBAZEPINE ACETATE

DMF 393122023

ARENE LIFE SCIENCES LTDESLICARBAZEPINE ACETATE

DMF 408932024

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDESLICARBAZEPINE ACETATE

DMF 424352025

BIAL PORTELA AND CA SAInactiveESLICARBAZEPINE ACETATE DRUG SUBSTANCE

DMF 220262008

DR REDDYS LABORATORIES LTDInactiveESLICARBAZEPINE ACETATE

DMF 248172011

TIANJIN WEIJIE PHARMACEUTICAL CO LTDInactiveESLICARBAZEPINE ACETATE

DMF 304852016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 7, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 29, 2021

No patent or exclusivity listings for this strength.

#002 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 29, 2021

#003 — 600MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 29, 2021

#004 — 800MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 29, 2021