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BINOSTO Drug Profile
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Which patents cover Binosto, and when can generic versions of Binosto launch?
Binosto is a drug marketed by Ascend Theraps Us and is included in one NDA. There are two patents protecting this drug.
This drug has eleven patent family members in seven countries.
The generic ingredient in BINOSTO is alendronate sodium. There are twenty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Binosto
A generic version of BINOSTO was approved as alendronate sodium by IMPAX LABS INC on February 6th, 2008.
Summary for BINOSTO
| International Patents: | 11 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 2 |
| Patent Applications: | 22 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BINOSTO |
| DailyMed Link: | BINOSTO at DailyMed |
Recent Clinical Trials for BINOSTO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Ghent | Phase 2 |
| Amgen | Phase 2 |
| EffRx Pharmaceuticals | Phase 2 |
Pharmacology for BINOSTO
| Drug Class | Bisphosphonate |
US Patents and Regulatory Information for BINOSTO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ascend Theraps Us | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ascend Theraps Us | BINOSTO | alendronate sodium | TABLET, EFFERVESCENT;ORAL | 202344-001 | Mar 12, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for BINOSTO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2004035004 | Start Trial |
| Austria | 541575 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03075884 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BINOSTO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | 2007C/048 | Belgium | Start Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
