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, Waylis Therap, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Norvium Bioscience, 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: | 47 |
| Patent Applications: | 1,891 |
| 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 |
| TenNor Therapeutics (Suzhou) Limited | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-002 | Mar 26, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 204179-001 | Jul 31, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Waylis Therap | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-001 | May 29, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 205761-001 | Feb 17, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 076824-001 | Nov 8, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-001 | Mar 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-001 | May 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-002 | Aug 19, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Waylis Therap | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973-001 | May 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-002 | Mar 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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