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, Mylan Pharms Inc, 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.
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sagent Pharms Inc | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 202235-001 | Sep 2, 2014 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eugia Pharma | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 205332-001 | Aug 19, 2015 | AP | RX | No | 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 |