ACIPHEX Drug Patent Profile

Which patents cover Aciphex, and what generic alternatives are available?

Aciphex is a drug marketed by Waylis Therap and Aytu and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aciphex

A generic version of ACIPHEX was approved as rabeprazole sodium by CHARTWELL RX on November 8^th, 2013.

Summary for ACIPHEX

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	22
Patent Applications:	3,646
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACIPHEX
What excipients (inactive ingredients) are in ACIPHEX?	ACIPHEX excipients list
DailyMed Link:	ACIPHEX at DailyMed

See drug prices for ACIPHEX

See drug sales revenues for ACIPHEX

Recent Clinical Trials for ACIPHEX

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

Sponsor	Phase
Pfizer	Phase 1
Janssen Research & Development, LLC	Phase 1
Eisai Inc.	Phase 1

See all ACIPHEX clinical trials

Pharmacology for ACIPHEX

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

US Patents and Regulatory Information for ACIPHEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002		DISCN	Yes	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013		DISCN	Yes	No
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	AB	RX	Yes	Yes

Expired US Patents for ACIPHEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999

International Patents for ACIPHEX

See the table below for patents covering ACIPHEX around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0475456	Dérivés de pyridine, leurs compositions pharmaceutiques, leur utilisation pour la fabrication de médicaments ayant une valeur thérapeutique ou préventive, et un procédé pour leur préparation (Pyridine derivatives, pharmaceutical compositions comprising the same, the use of the same for the manufacture of medicaments having therapeutic or preventative value, and a process for preparing the same)
Canada	1336958	PREPARATION PERORALE D'UN COMPOSE INSTABLE EN MILIEU ACIDE (PERORAL PREPARATION OF ACID-UNSTABLE COMPOUND)
Germany	19975035

Supplementary Protection Certificates for ACIPHEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	C990015	Netherlands		PRODUCT NAME: RABEPRAZOLI, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RABEPRAZOLI NATRICUM; NATL REGISTRATION NO/DATE: RVG 23210-11 19981208; FIRST REGISTRATION: GB 10555/0008 AND 10555/0010 19980508
0268956	SPC/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
0268956	21/1999	Austria		PRODUCT NAME: RABEPRAZOL UND SEINE PHARMAZEUTISCH GEEIGNETEN SALZE, INSBESONDERE RABEPRAZOL-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22777 UND 1-22778 19981112; FIRST REGISTRATION: GB 10555/0010 UND 10555/0008 19980508