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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.
Summary for ACIPHEX
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 170 |
| Clinical Trials: | 17 |
| Patent Applications: | 2,398 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACIPHEX |
| Drug Sales Revenues: | Drug sales revenues for ACIPHEX |
| DailyMed Link: | ACIPHEX at DailyMed |
Recent Clinical Trials for ACIPHEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Eisai Inc. | Phase 1 |
| Janssen Research & Development, LLC | Phase 1 |
Pharmacology for ACIPHEX
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton 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 |
International Patents for ACIPHEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2118457 | Start Trial |
| Netherlands | 990015 | Start Trial |
| Austria | 163011 | Start Trial |
| Germany | 3752167 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
