ACIPHEX Drug Patent Profile
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Which patents cover Aciphex, and when can generic versions of Aciphex launch?
Aciphex is a drug marketed by Woodward 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 8th, 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: | 3,548 |
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 |
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 |
Pharmacology for ACIPHEX
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ACIPHEX
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Woodward | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-001 | May 29, 2002 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-002 | Mar 26, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Woodward | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-002 | Aug 19, 1999 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-001 | Mar 26, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Woodward | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-002 | Aug 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-001 | May 29, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-002 | Aug 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Woodward | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-001 | May 29, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACIPHEX
See the table below for patents covering ACIPHEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1018923 | ⤷ Try a Trial | |
Finland | 874709 | ⤷ Try a Trial | |
Japan | S646270 | PYRIDINE DERIVATIVE AND REMEDY FOR ULCERATION CONTAINING THE SAME | ⤷ Try a Trial |
Norway | 178135 | ⤷ Try a Trial | |
Japan | H05247035 | ⤷ Try a Trial | |
Denmark | 131893 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACIPHEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0268956 | 21/1999 | Austria | ⤷ Try a 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 | C990015 | Netherlands | ⤷ Try a 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 |
0268956 | 1999C0030 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
0268956 | SPC/GB98/040 | United Kingdom | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |