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.
Summary for BINOSTO
| International Patents: | 31 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Clinical Trials: | 2 |
| Patent Applications: | 111 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BINOSTO |
| What excipients (inactive ingredients) are in BINOSTO? | BINOSTO excipients list |
| DailyMed Link: | BINOSTO at DailyMed |
Recent Clinical Trials for BINOSTO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EffRx Pharmaceuticals | Phase 2 |
| Amgen | Phase 2 |
| University Hospital, Ghent | Phase 2 |
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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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.
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