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ACIPHEX

NDA

RABEPRAZOLE SODIUM | N020973 | WAYLIS THERAPEUTICS LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services Inc FDA-2004-P-0006 · 6 docket documents Lachman Consultant Services Inc filed this petition on behalf of a client requesting that the FDA Commissioner determine whether Aciphex (rabeprazole sodium) Delayed-release Tablets, 10 mg (NDA 20-973), manufactured by Eisai Inc., was voluntarily withdrawn or withheld from sale for safety or effecti	505(q)	2014-01-21	Denied	Lachman Consultant Services Inc
Citizen Petition from Caryn Kanzer FDA-2009-P-0186 · 4 docket documents Caryn Kanzer, a private citizen, petitioned the Food and Drug Administration under 21 C.F.R. 10.30 to immediately remove Patent 5,045,552 from the Orange Book and permit generic equivalents of rabeprazole sodium (Aciphex) to enter the market. Kanzer argued that the patent specifically claims coverag	505(q)	2009-04-20	Denied	Caryn Kanzer

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

130 trials from ClinicalTrials.gov, 1 active, 107 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD NCT02407119	Phase 3	Active	National Cancer Center, Korea	470	2003-06 → 2030-06
Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects NCT04211545	Phase 1	Completed	Celgene	24	2019-10-21 → 2019-12-26
A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation NCT03130556	Phase 1	Completed	Pfizer	24	2017-05-01 → 2017-07-21
A Study to Compare the Number of Patients With Gastro-Oesophageal Reflux Disease (GORD) Achieving Heartburn and Regurgitation Symptom Resolution After Treatment With Either Rabeprazole Sodium 20mg, Esomeprazole 20mg or Esomeprazole 40mg NCT00464308	Phase 4	Completed	Janssen-Cilag Pty Ltd	1,392	2006-11 → 2008-05
A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn NCT00237367	Phase 4	Completed	PriCara, Unit of Ortho-McNeil, Inc.	52	— → 2005-04
Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg NCT00648349	Phase 1	Completed	Mylan Pharmaceuticals Inc	72	2003-05 → 2003-06
A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes NCT00681005	N/A	Completed	National Taiwan University Hospital	178	2006-04 → 2008-01
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants NCT03290703	Phase 1	Completed	Genentech, Inc.	63	2017-04-18 → 2018-10-25
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients NCT00517114	N/A	Completed	Hospital Authority, Hong Kong	200	2005-01 → 2008-12
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)NCT01085708	Phase 1	Completed	Eisai Co., Ltd.	16	2010-04 → 2010-05

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

Medicare Part D Spending

CMS annual spending data for Aciphex (2024)

Total Spending

$16.4M

Total Claims

6,163

Beneficiaries

1,549

Avg Cost/Unit

$29.03

Spending Trend

$19.7M(2019)→$18.1M(2020)→$16.2M(2021)→$4.5M(2022)→$15.6M(2023)→$16.4M(2024)

YoY Change:+19.5%

5yr CAGR:+15.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain15 active DMFs16 inactive

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

DR REDDYS LABORATORIES LTDRABEPRAZOLE SODIUM HYDRATE (FORM Y) USP

DMF 167472003

APITORIA PHARMA PRIVATE LTDRABEPRAZOLE SODIUM

DMF 191862006

TORRENT PHARMACEUTICALS LTDRABEPRAZOLE SODIUM USP

DMF 217362008

DR REDDYS LABORATORIES LTDRABEPRAZOLE SODIUM HYDRATE (FORM-Y), USP

DMF 220312008

SYN-TECH CHEM AND PHARM CO LTDRABEPRAZOLE SODIUM

DMF 234002009

MOEHS IBERICA SLRABEPRAZOLE SODIUM

DMF 249242011

ORCHID PHARMA LTDRABEPRAZOLE SODIUM

DMF 250322011

QUIMICA SINTETICA SARABEPRAZOLE SODIUM (PROCESS II)

DMF 253092011

RAKS PHARMA PVT LTDRABEPRAZOLE SODIUM USP

DMF 256482011

MACLEODS PHARMACEUTICALS LTDRABEPRAZOLE SODIUM

DMF 257112012

ALKEM LABORATORIES LTDRABEPRAZOLE SODIUM USP

DMF 274032013

STERILE INDIA PVT LTDRABEPRAZOLE SODIUM (STERILE)

DMF 299802016

METROCHEM API PRIVATE LTDRABEPRAZOLE SODIUM

DMF 353442020

METROCHEM API PRIVATE LTDRABEPRAZOLE SODIUM (Y-FORM)

DMF 376302022

MAITHRI LABORATORIES PRIVATE LTDRABEPRAZOLE SODIUM USP

DMF 438672026

CIPLA LTDInactiveRABEPRAZOLE SODIUM

DMF 167642003

CADILA HEALTHCARE LTDInactiveRABEPRAZOLE SODIUM

DMF 182262005

LUPIN LTDInactiveRABEPRAZOLE SODIUM USP

DMF 199032006

AMINO CHEMICALS LTDInactiveRABEPRAZOLE SODIUM MONOHYDRATE

DMF 208182007

CADILA PHARMACEUTICALS LTDInactiveRABEPRAZOLE SODIUM

DMF 210342007

CADILA HEALTHCARE LTDInactiveRabeprazole Sodium (Amorphous)

DMF 211922007

MYLAN LABORATORIES LTDInactiveRABEPRAZOLE SODIUM

DMF 212032007

RANBAXY LABORATORIES LTDInactiveRabeprazole Sodium (Non-Sterile Bulk Drug Substance)

DMF 212052007

UQUIFA MEXICO SA DE CVInactiveRABEPRAZOLE SODIUM

DMF 214952008

CHEMO IBERICA SA MADRIDInactiveRABEPRAZOLE SODIUM (PROCESS I)

DMF 215852008

SINTENOVO SA DE CVInactiveRABEPRAZOLE SODIUM

DMF 239072010

ALEMBIC PHARMACEUTICALS LTDInactiveRABEPRAZOLE SODIUM

DMF 248302011

HETERO DRUGS LTDInactiveRABEPRAZOLE SODIUM

DMF 249732011

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveRABEPRAZOLE SODIUM

DMF 253202011

NOSCH LABS PRIVATE LTDInactiveRABEPRAZOLE SODIUM

DMF 269132013

SHANGHAI SINE PHARMACEUTICAL LABORATORIES CO LTDInactiveRABEPRAZOLE SODIUM

DMF 272252013

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

Approval Letters

24 letters from Drugs@FDA

Date	Submission	Document
Jul 19, 2023	SUPPL -43	View Letter (PDF)
Mar 7, 2022	SUPPL -42	View Letter (PDF)
Mar 7, 2022	SUPPL -42	View Letter (PDF)
Nov 30, 2020	SUPPL -41	View Letter (PDF)
Jun 14, 2018	SUPPL -39	View Letter (PDF)
Jan 11, 2018	SUPPL -38	View Letter (PDF)
Oct 26, 2016	SUPPL -37	View Letter (PDF)
Apr 6, 2016	SUPPL -33	View Letter (PDF)
Dec 24, 2014	SUPPL -35	View Letter (PDF)
Oct 21, 2014	SUPPL -34	View Letter (PDF)
Apr 23, 2013	SUPPL -32	View Letter (PDF)
Oct 10, 2012	SUPPL -29	View Letter (PDF)
May 10, 2012	SUPPL -30	View Letter (PDF)
May 25, 2011	SUPPL -28	View Letter (PDF)
Sep 8, 2010	SUPPL -25	View Letter (PDF)
Jul 2, 2008	SUPPL -22	View Letter (PDF)
Jun 7, 2005	SUPPL -20	View Letter (PDF)
Aug 15, 2003	SUPPL -16	View Letter (PDF)
Nov 8, 2002	SUPPL -13	View Letter (PDF)
Sep 30, 2002	SUPPL -15	View Letter (PDF)
Sep 23, 2002	SUPPL -14	View Letter (PDF)
May 29, 2002	SUPPL -12	View Letter (PDF)
Feb 12, 2002	SUPPL -9	View Letter (PDF)
Aug 19, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: May 29, 2002

No patent or exclusivity listings for this strength.

#002 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Aug 19, 1999