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Last Updated: January 22, 2021

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ACIPHEX Drug Profile

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

Aciphex is a drug marketed by Eisai Inc 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.

US ANDA Litigation and Generic Entry Outlook for Aciphex

A generic version of ACIPHEX was approved as rabeprazole sodium by DR REDDYS on November 8th, 2013.

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Drug patent expirations by year for ACIPHEX
Drug Prices for ACIPHEX

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Drug Sales Revenue Trends for ACIPHEX

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Recent Clinical Trials for ACIPHEX

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

SponsorPhase
PfizerPhase 1
Eisai Inc.Phase 1
Janssen Research & Development, LLCPhase 1

See all ACIPHEX clinical trials

Pharmacology for ACIPHEX
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors
Paragraph IV (Patent) Challenges for ACIPHEX
Tradename Dosage Ingredient NDA Submissiondate
ACIPHEX TABLET, DELAYED RELEASE;ORAL rabeprazole sodium 020973

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
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002 DISCN Yes No   Start Trial   Start Trial   Start Trial
Aytu ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-002 Mar 26, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Aytu ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-001 Mar 26, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
>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 ACIPHEX

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

Supplementary Protection Certificates for ACIPHEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0268956 1999C0030 Belgium   Start Trial PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0268956 21/1999 Austria   Start Trial 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
0268956 SPC/GB98/040 United Kingdom   Start Trial 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 C990015 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Colorcon
Express Scripts
Harvard Business School
AstraZeneca

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