IBANDRONATE SODIUM Drug Patent Profile
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Which patents cover Ibandronate Sodium, and when can generic versions of Ibandronate Sodium launch?
Ibandronate Sodium is a drug marketed by Accord Hlthcare, Apotex, Avet Lifesciences, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Norvium Bioscience, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva. and is included in sixteen NDAs.
The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ibandronate Sodium
A generic version of IBANDRONATE SODIUM was approved as ibandronate sodium by APOTEX INC on March 19th, 2012.
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Summary for IBANDRONATE SODIUM
Recent Clinical Trials for IBANDRONATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Southwest Oncology Group | |
| National Cancer Institute (NCI) | |
| Dr. Reddy's Laboratories Limited | Phase 1 |
Pharmacology for IBANDRONATE SODIUM
| Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for IBANDRONATE SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BONIVA | Injection | ibandronate sodium | 1 mg/mL, 3 mL Vial | 021858 | 1 | 2007-08-31 |
| BONIVA | Tablets | ibandronate sodium | 2.5 mg | 021455 | 1 | 2007-05-16 |
US Patents and Regulatory Information for IBANDRONATE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 206058-001 | Feb 5, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent Pharms Inc | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 202235-001 | Sep 2, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 205332-001 | Aug 19, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Macleods Pharms Ltd | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 206887-001 | Oct 31, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 090853-001 | Feb 14, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs Teva | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 079003-001 | Mar 20, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Orbion Pharms | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078998-001 | Mar 19, 2012 | 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 |
