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DEXLANSOPRAZOLE

ANDA

DEXLANSOPRAZOLE | A202666 | TWI PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DEXILANT(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Takeda Pharmaceutical Co., Ltd. et al v. TWi Pharmaceuticals, Inc. 5:2013cv02420 1 patentANDA 202666dexlansoprazole	CAND	2013-05-29	Terminated 2015-06-08	—

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

API Supply Chain22 active DMFs6 inactive

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

DR REDDYS LABORATORIES LTDDEXLANSOPRAZOLE (AMORPHOUS)

DMF 226072009

DR REDDYS LABORATORIES LTDDEXLANSOPRAZOLE (CRYSTALLINE)

DMF 236552010

MSN LABORATORIES PRIVATE LTDDEXLANSOPRAZOLE ANHYDROUS [ROUTE CODE - "DZ"]

DMF 237222010

MATRIX PHARMACORP PRIVATE LTDDEXLANSOPRAZOLE SESQUIHYDRATE

DMF 245032010

MSN LABORATORIES PRIVATE LTDDEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE - "DP"]

DMF 248152011

ORCHID PHARMA LTDDEXLANSOPRAZOLE

DMF 252352011

RAKS PHARMA PVT LTDDEXLANSOPRAZOLE API

DMF 260872012

JUBILANT PHARMOVA LTDDEXLANSOPRAZOLE

DMF 280522014

APOTEX INCDEXLANSOPRAZOLE ANHYDRATE

DMF 290352015

RAKS PHARMA PVT LTDDEXLANSOPRAZOLE (ROUTE CODE - DR)

DMF 300842016

DIPHARMA FRANCIS SRLDEXLANSOPRAZOLE ANHYDROUS

DMF 323972018

PIRAMAL PHARMA LTDDEXLANSOPRAZOLE

DMF 336852019

HETERO DRUGS LTDDEXLANSOPRAZOLE

DMF 338812019

METROCHEM API PRIVATE LTDDEXLANSOPRAZOLE

DMF 349712020

OPTIMUS DRUGS PRIVATE LTDDEXLANSOPRAZOLE

DMF 351352020

CHROMO LABORATORIES INDIA PRIVATE LTDDEXLANSOPRAZOLE SESQUIHYDRATE

DMF 374422022

ALEMBIC PHARMACEUTICALS LTDDEXLANSOPRAZOLE

DMF 375392022

HETERO DRUGS LTDDEXLANSOPRAZOLE SESQUIHYDRATE

DMF 376062022

LEE PHARMA LTDDEXLANSOPRAZOLE SESQUIHYDRATE

DMF 381832023

METROCHEM API PRIVATE LTDDEXLANSOPRAZOLE (DXJ)

DMF 389972023

METROCHEM API PRIVATE LTDDEXLANSOPRAZOLE ANHYDROUS

DMF 395952024

METROCHEM API PRIVATE LTDDEXLANSOPRAZOLE ANHYDROUS (DXM)

DMF 434112025

DIPHARMA FRANCIS SRLInactiveDEXLANSOPRAZOLE

DMF 233802009

DIPHARMA FRANCIS SRLInactiveDEXLANSOPRAZOLE ANHYDROUS

DMF 248752011

MYLAN LABORATORIES LTDInactiveDEXLANSOPRAZOLE AMORPHOUS

DMF 251112011

LUPIN LTDInactiveDEXLANSOPRAZOLE

DMF 278342014

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveDEXLANSOPRAZOLE

DMF 293462015

DIPHARMA FRANCIS SRLInactiveDEXLANSOPRAZOLE AMORPHOUS

DMF 323082018

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

Products (2)

Sort:

#001 — 30MG

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Sep 16, 2022

No patent or exclusivity listings for this strength.

#002 — 60MG

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Sep 16, 2022