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Last Updated: January 17, 2021

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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.

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Drug patent expirations by year for BINOSTO
Drug Prices for BINOSTO

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Recent Clinical Trials for BINOSTO

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SponsorPhase
University Hospital, GhentPhase 2
AmgenPhase 2
EffRx PharmaceuticalsPhase 2

See all BINOSTO clinical trials

Pharmacology for BINOSTO
Drug ClassBisphosphonate

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

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

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