Ibandronate sodium - Generic Drug Details
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What are the generic drug sources for ibandronate sodium and what is the scope of freedom to operate?
Ibandronate sodium
is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Emcure Pharms Ltd, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, 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 eighteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ibandronate sodium has seventy-one patent family members in thirty-two countries.
There are eleven drug master file entries for ibandronate sodium. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ibandronate sodium
International Patents: | 71 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 18 |
NDAs: | 18 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 163 |
Clinical Trials: | 8 |
Patent Applications: | 371 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ibandronate sodium |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ibandronate sodium |
What excipients (inactive ingredients) are in ibandronate sodium? | ibandronate sodium excipients list |
DailyMed Link: | ibandronate sodium at DailyMed |
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 |
Generic filers with tentative approvals for IBANDRONATE SODIUM
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 2.5MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 1MG | INJECTABLE; INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Macleods Pharms Ltd | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 206887-001 | Oct 31, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Dr Reddys Labs Ltd | IBANDRONATE SODIUM | ibandronate sodium | TABLET;ORAL | 078997-001 | Apr 30, 2012 | AB | RX | No | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Apotex | IBANDRONATE SODIUM | ibandronate sodium | INJECTABLE;INTRAVENOUS | 204222-001 | Oct 16, 2015 | AP | RX | No | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 ibandronate sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-001 | May 16, 2003 | See Plans and Pricing | See Plans and Pricing |
Roche | BONIVA | ibandronate sodium | INJECTABLE;INTRAVENOUS | 021858-001 | Jan 6, 2006 | See Plans and Pricing | See Plans and Pricing |
Hoffmann La Roche | BONIVA | ibandronate sodium | TABLET;ORAL | 021455-002 | Mar 24, 2005 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ibandronate sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1939314 | Ibandronic acid for the treatment and prevention of osteoporosis | See Plans and Pricing |
South Korea | 100642961 | See Plans and Pricing | |
Denmark | 1880744 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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