Viewing data from:

PREVACID

NDA

LANSOPRAZOLE | N021428 | TAKEDA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TAKEDA PHARMACEUTICAL COMPANY LIMITED et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 3:2010cv01723 3 patentsANDA 200816lansoprazole	D.N.J.	2010-04-05	Terminated 2014-10-16	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

145 trials from ClinicalTrials.gov, 107 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study NCT01046253	Phase 1	Completed	Teva Pharmaceuticals USA	50	2004-01 → 2004-01
A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.NCT00220818	Phase 1	Completed	Takeda	24	2005-01 → 2005-07
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease NCT01135368	Phase 4	Completed	Takeda	506	2002-06 → 2008-09
Prophylaxis for Aspiration of Gastric Contents.NCT02703896	Phase 4	Completed	King Saud University	1,920	2012-01 → 2015-12
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety NCT02679508	Phase 4	Completed	Takeda	208	2016-03-20 → 2022-03-05
Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin NCT01452763	Phase 3	Completed	Takeda	621	2011-10 → 2013-04
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions NCT01270308	Phase 1	Completed	Dr. Reddy's Laboratories Limited	48	2008-12 → 2008-12
Triple Therapy With Tegoprazan in H. Pylori Positive Patients NCT03498456	Phase 3	Completed	HK inno.N Corporation	284	2018-06-28 → 2019-12-31
Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed NCT00644735	Phase 4	Completed	AstraZeneca	750	2002-12 → 2004-01
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes NCT01155284	Phase 2	Completed	Sanford Health	70	2010-08 → 2015-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$13.24

per ea

Lowest NADAC/Unit

$13.22

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64764054411PREVACID DR 30 MG SOLUTAB	$13.24	EA	Brand	$2.18	2026-06-17
64764054311PREVACID DR 15 MG SOLUTAB	$13.22	EA	Brand	$1.66	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$1009.02

Highest Price

$1009.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64764-0543-11PREVACID SOLUTAB 15MG TAB, ORAL	$1009.28	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
64764-0544-11PREVACID SOLUTAB 30MG TAB,ORAL	$1009.02	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain24 active DMFs17 inactive

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

TAPI NL BVLANSOPRAZOLE

DMF 175512004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)LANSOPRAZOLE

DMF 177872004

MOEHS IBERICA SLLANSOPRAZOLE

DMF 178192004

MATRIX PHARMACORP PRIVATE LTDLANSOPRAZOLE USP

DMF 195552006

ZYDUS LIFESCIENCES LTDLANSOPRAZOLE USP

DMF 197942006

HETERO DRUGS LTDLANSOPRAZOLE

DMF 208732007

DR REDDYS LABORATORIES LTDLANSOPRAZOLE FORM-1

DMF 214262008

WOCKHARDT LTDLANSOPRAZOLE USP

DMF 216052008

ORCHID PHARMA LTDLANSOPRAZOLE (NON-STERILE BULK API)

DMF 216362008

JUBILANT PHARMOVA LTDLANSOPRAZOLE USP

DMF 219882009

SUN PHARMACEUTICAL INDUSTRIES LTDLANSOPRAZOLE USP

DMF 226632009

NATCO PHARMA LTDLANSOPRAZOLE

DMF 235232010

ULKAR KIMYA SANAYII VE TICARET ASLANSOPRAZOLE USP

DMF 237852010

QUIMICA SINTETICA SALANSOPRAZOLE USP

DMF 244872010

ALKEM LABORATORIES LTDLANSOPRAZOLE USP

DMF 251522011

MACLEODS PHARMACEUTICALS LTDLANSOPRAZOLE

DMF 257942012

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDLANSOPRAZOLE

DMF 258772012

LEE PHARMA LTDLANSOPRAZOLE USP

DMF 267992013

MURLI KRISHNA PHARMA PVT LTDLANSOPRAZOLE PELLETS 8.5 % W/W

DMF 274132013

QUIMICA SINTETICA SALANSOPRAZOLE (PROCESS II)

DMF 294622015

MACLEODS PHARMACEUTICALS LTDLANSOPRAZOLE DELAYED - RELEASE PELLETS

DMF 300212015

CHROMO LABORATORIES INDIA PRIVATE LTDLANSOPRAZOLE USP

DMF 353052021

METROCHEM API PRIVATE LTDLANSOPRAZOLE USP

DMF 354852020

MSN ORGANICS PRIVATE LTDLANSOPRAZOLE USP

DMF 415982025

DR REDDYS LABORATORIES LTDInactiveLANSOPRAZOLE FORM-1

DMF 170142003

ITF CHEMICAL LTDAInactiveLANSOPRAZOLE

DMF 182052005

LUPIN LTDInactiveLANSOPRAZOLE USP

DMF 182512005

FLAMMA SPAInactiveLANSOPRAZOLE

DMF 192292006

YANGTZE RIVER PHARMACY GROUP JIANGSU HAI CI BIOLOGICAL PHARMACY CO LTDInactiveLANSOPRAZOLE, NON-STERILE DRUG SUBSTANCE

DMF 192542006

ESTEVE QUIMICA SAInactiveLANSOPRAZOLE

DMF 193102006

SYN-TECH CHEM AND PHARM CO LTDInactiveLANSOPRAZOLE USP

DMF 195372006

CIPLA LTDInactiveLANSOPRAZOLE USP

DMF 197252006

AREVIPHARMA GMBHInactiveLansoprazole

DMF 210772007

RANBAXY LABORATORIES LTDInactiveLANSOPRAZOLE USP

DMF 211432007

SMS PHARMACEUTICALS LTDInactiveLANSOPRAZOLE USP

DMF 215522008

KRKA DD NOVO MESTOInactiveLANSOPRAZOLE ACTIVE SUBSTANCE

DMF 223212008

DERIVADOS QUIMICOS SA FINE CHEMICALSInactiveLANSOPRAZOLE

DMF 235782010

APOTEX PHARMACHEM INDIA PVT LTDInactiveLANSOPRAZOLE USP

DMF 254932011

IOL CHEMICALS AND PHARMACEUTICALS LTDInactiveLANSOPRAZOLE

DMF 265862012

NOSCH LABS PRIVATE LTDInactiveLANSOPRAZOLE, USP

DMF 269142013

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveLANSOPRAZOLE

DMF 283802014

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

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Aug 9, 2023	SUPPL -42	View Letter (PDF)
Mar 7, 2022	SUPPL -41	View Letter (PDF)
Nov 30, 2020	SUPPL -39	View Letter (PDF)
Sep 14, 2020	SUPPL -37	View Letter (PDF)
Jun 14, 2018	SUPPL -34	View Letter (PDF)
Jun 14, 2018	SUPPL -35	View Letter (PDF)
Apr 16, 2018	SUPPL -32	View Letter (PDF)
Oct 19, 2017	SUPPL -31	View Letter (PDF)
Oct 26, 2016	SUPPL -30	View Letter (PDF)
Dec 18, 2015	SUPPL -27	View Letter (PDF)
Dec 24, 2014	SUPPL -28	View Letter (PDF)
Oct 2, 2012	SUPPL -25	View Letter (PDF)
May 9, 2012	SUPPL -26	View Letter (PDF)
Oct 31, 2011	SUPPL -23	View Letter (PDF)
Jun 3, 2011	SUPPL -22	View Letter (PDF)
May 25, 2011	SUPPL -24	View Letter (PDF)
May 17, 2010	SUPPL -20	View Letter (PDF)
Nov 12, 2009	SUPPL -19	View Letter (PDF)
Oct 29, 2008	SUPPL -17	View Letter (PDF)
Apr 23, 2008	SUPPL -13	View Letter (PDF)
Jul 5, 2007	SUPPL -12	View Letter (PDF)
Apr 13, 2006	SUPPL -6	View Letter (PDF)
Jun 23, 2004	SUPPL -4	View Letter (PDF)
Aug 15, 2003	SUPPL -1	View Letter (PDF)
Aug 30, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG

RLDAB

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Approved: Aug 30, 2002

No patent or exclusivity listings for this strength.

#002 — 30MG

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Approved: Aug 30, 2002