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ACIPHEX SPRINKLE

NDA

RABEPRAZOLE SODIUM | N204736 | AYTU BIOSCIENCE 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain15 active DMFs15 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

HETERO DRUGS LTDRABEPRAZOLE SODIUM

DMF 249732011

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

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

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

8 letters from Drugs@FDA

Date	Submission	Document
Dec 1, 2020	SUPPL -12	View Letter (PDF)
Jun 14, 2018	SUPPL -10	View Letter (PDF)
Jul 28, 2017	SUPPL -8	View Letter (PDF)
Oct 26, 2016	SUPPL -7	View Letter (PDF)
Apr 6, 2016	SUPPL -3	View Letter (PDF)
Dec 24, 2014	SUPPL -5	View Letter (PDF)
Oct 21, 2014	SUPPL -4	View Letter (PDF)
Mar 28, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Mar 26, 2013

No patent or exclusivity listings for this strength.

#002 — 10MG

RLD

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Mar 26, 2013