RABEPRAZOLE SODIUM - Generic Drug Details

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What are the generic sources for rabeprazole sodium and what is the scope of patent protection?

Rabeprazole sodium is the generic ingredient in three branded drugs marketed by Aytu, Waylis Therap, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Norvium Bioscience, Rubicon, Teva Pharms Usa, and Torrent, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for rabeprazole sodium. Twenty-three suppliers are listed for this compound.

Summary for RABEPRAZOLE SODIUM

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	12
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	47
Patent Applications:	1,891
What excipients (inactive ingredients) are in RABEPRAZOLE SODIUM?	RABEPRAZOLE SODIUM excipients list
DailyMed Link:	RABEPRAZOLE SODIUM at DailyMed

Recent Clinical Trials for RABEPRAZOLE SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
TenNor Therapeutics (Suzhou) Limited	Phase 3
Xuanzhu Biopharmaceutical Co., Ltd.	Phase 2
TenNor Therapeutics (Suzhou) Limited	Phase 2

See all RABEPRAZOLE SODIUM clinical trials

Pharmacology for RABEPRAZOLE SODIUM

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for RABEPRAZOLE SODIUM

Anti-Ulcer Agents
Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RABEPRAZOLE SODIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for RABEPRAZOLE SODIUM

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	204179-001	Jul 31, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	205761-001	Feb 17, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for RABEPRAZOLE SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013	⤷ Sign Up	⤷ Sign Up
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	⤷ Sign Up	⤷ Sign Up
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	⤷ Sign Up	⤷ Sign Up
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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