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RISEDRONATE SODIUM Drug Profile
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When do Risedronate Sodium patents expire, and what generic alternatives are available?
Risedronate Sodium is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex Inc, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orchid Hlthcare. and is included in fourteen NDAs.
The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Risedronate Sodium
A generic version of RISEDRONATE SODIUM was approved as risedronate sodium by TEVA PHARMS USA on October 5th, 2007.
Summary for RISEDRONATE SODIUM
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 14 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 10 |
| Patent Applications: | 1,859 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RISEDRONATE SODIUM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RISEDRONATE SODIUM |
| What excipients (inactive ingredients) are in RISEDRONATE SODIUM? | RISEDRONATE SODIUM excipients list |
| DailyMed Link: | RISEDRONATE SODIUM at DailyMed |
Recent Clinical Trials for RISEDRONATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sheffield Children's NHS Foundation Trust | Phase 2 |
| Takeda | N/A |
| Chugai Pharmaceutical | Phase 3 |
Pharmacology for RISEDRONATE SODIUM
| Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for RISEDRONATE SODIUM
Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ATELVIA | TABLET, DELAYED RELEASE;ORAL | risedronate sodium | 022560 | 2011-06-09 |
| ACTONEL | TABLET;ORAL | risedronate sodium | 020835 | 2008-08-12 |
| ACTONEL | TABLET;ORAL | risedronate sodium | 020835 | 2007-09-10 |
| ACTONEL | TABLET;ORAL | risedronate sodium | 020835 | 2007-09-07 |
| ACTONEL | TABLET;ORAL | risedronate sodium | 020835 | 2004-04-23 |
US Patents and Regulatory Information for RISEDRONATE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 077132-001 | Oct 5, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Pharms Usa | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 077132-002 | Oct 5, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Impax Labs Inc | RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 205066-001 | Jun 29, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 200477-003 | Nov 30, 2015 | DISCN | No | 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 |
