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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
UBS
Daiichi Sankyo
McKesson
AstraZeneca
Baxter
Mallinckrodt
Queensland Health
Johnson and Johnson
Express Scripts

Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204736

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NDA 204736 describes ACIPHEX SPRINKLE, which is a drug marketed by Fsc Therap and is included in one NDA. It is available from one supplier. Additional details are available on the ACIPHEX SPRINKLE profile page.

The generic ingredient in ACIPHEX SPRINKLE is rabeprazole sodium. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for NDA: 204736

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204736

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 204736

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL 204736 NDA Avadel Pharmaceuticals (USA), Inc. 13551-205 13551-205-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (13551-205-01)
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL 204736 NDA Avadel Pharmaceuticals (USA), Inc. 13551-210 13551-210-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (13551-210-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength5MG
Approval Date:Mar 26, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 26, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength10MG
Approval Date:Mar 26, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 26, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 204736

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fsc Therap
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-001Mar 26, 2013► Subscribe► Subscribe
Fsc Therap
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-002Mar 26, 2013► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Boehringer Ingelheim
Colorcon
AstraZeneca
Healthtrust
Daiichi Sankyo
Dow
Cerilliant
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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