Rabeprazole sodium - Generic Drug Details
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What are the generic drug 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, Woodward, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Mylan, 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: | 45 |
Patent Applications: | 1,891 |
Formulation / Manufacturing: | see details |
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 |
Boehringer Ingelheim | Phase 1 |
Pharmacology for rabeprazole sodium
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for rabeprazole sodium
Anatomical Therapeutic Chemical (ATC) Classes for rabeprazole sodium
US Patents and Regulatory Information for rabeprazole sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rubicon | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 204237-001 | Nov 18, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aurobindo Pharma | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 205761-001 | Feb 17, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 076824-001 | Nov 8, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lannett Co Inc | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 090678-001 | Nov 8, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Torrent | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 202376-001 | Nov 8, 2013 | AB | RX | No | No | ⤷ 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 rabeprazole sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | 020973-001 | May 29, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-001 | Mar 26, 2013 | ⤷ 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 | 020973-002 | Aug 19, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-002 | Mar 26, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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