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Last Updated: May 21, 2022

BINOSTO Drug Patent 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 three patents protecting this drug.

This drug has thirty-one patent family members in seventeen countries.

The generic ingredient in BINOSTO is alendronate sodium. There are twenty-five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Binosto

A generic version of BINOSTO was approved as alendronate sodium by APOTEX on August 4th, 2008.

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Summary for BINOSTO
Drug patent expirations by year for BINOSTO
Drug Prices for BINOSTO

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Recent Clinical Trials for BINOSTO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
EffRx PharmaceuticalsPhase 2
AmgenPhase 2
University Hospital, GhentPhase 2

See all BINOSTO clinical trials

US Patents and Regulatory Information for BINOSTO

BINOSTO is protected by three US patents.

Patents protecting BINOSTO

Effervescent compositions comprising bisphosphonates and methods related thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Effervescent compositions comprising phosphonates and methods related thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable effervescent bisphosphonate formulations with rapid solubilization characteristics
Patent Number: See Plans and Pricing
Patent Expiration: 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
Ascend Theraps Us BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344-001 Mar 12, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Ascend Theraps Us BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344-001 Mar 12, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ascend Theraps Us BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344-001 Mar 12, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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

International Patents for BINOSTO

See the table below for patents covering BINOSTO around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2608724 СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ (STABLE FORMULATIONS OF EFFERVESCENT BISPHOSPHONATE WITH PROPERTIES OF FAST SOLUBILIZATION) See Plans and Pricing
Australia 2003284275 EFFERVESCENT COMPOSITIONS COMPRISING BISPHOSPHONATES AND METHODS RELATED THERETO See Plans and Pricing
World Intellectual Property Organization (WIPO) 03075884 See Plans and Pricing
Denmark 2648702 See Plans and Pricing
Russian Federation 2013109765 СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BINOSTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.