RABEPRAZOLE SODIUM Drug Patent Profile
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When do Rabeprazole Sodium patents expire, and what generic alternatives are available?
Rabeprazole Sodium is a drug marketed by 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 ten NDAs.
The generic ingredient in RABEPRAZOLE SODIUM 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 Rabeprazole Sodium
A generic version of RABEPRAZOLE SODIUM was approved as rabeprazole sodium by CHARTWELL RX on November 8th, 2013.
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Summary for RABEPRAZOLE SODIUM
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 47 |
| Patent Applications: | 1,140 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 208644-001 | Apr 24, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 076885-001 | Nov 8, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 078964-001 | 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 |
