Viewing data from:

DEXLANSOPRAZOLE

ANDA

DEXLANSOPRAZOLE | A205205 | MYLAN 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. Mylan Inc et al 5:2014cv00314 1 patentANDA 205205dexlansoprazole	N.D. Cal.	2014-01-21	Terminated 2015-04-21	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$4.16

per ea

Lowest NADAC/Unit

$3.84

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378208593DEXLANSOPRAZOLE DR 30 MG CAP	$4.16	EA	Generic	—	2026-06-17
00378208677DEXLANSOPRAZOLE DR 60 MG CAP	$3.84	EA	Generic	—	2026-06-17
00378208693DEXLANSOPRAZOLE DR 60 MG CAP	$3.84	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain23 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 BIOSYS 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

MSN LABORATORIES PRIVATE LTDDEXLANSOPRAZOLE (SESQUIHYDRATE)

DMF 438302026

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: Jan 19, 2024

No patent or exclusivity listings for this strength.

#002 — 60MG

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Jan 19, 2024