.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Medtronic
Fuji
UBS
Moodys
Chinese Patent Office
Federal Trade Commission
QuintilesIMS
Chubb

Generated: December 18, 2017

DrugPatentWatch Database Preview

Alendronate sodium - Generic Drug Details

« Back to Dashboard

What are the generic sources for alendronate sodium and what is the scope of alendronate sodium freedom to operate?

Alendronate sodium
is the generic ingredient in four branded drugs marketed by West-ward Pharms Int, Merck, Mission Pharma, Apotex, Aurobindo Pharma, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Impax Labs Inc, Jubilant Cadista, Mylan, Sun Pharma Global, Teva Pharms, Upsher-smith Labs, Watson Labs, and Merck And Co Inc, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has one hundred and two patent family members in forty countries and nine supplementary protection certificates in five countries.

There are twenty-five drug master file entries for alendronate sodium. Thirty-two suppliers are listed for this compound.

Pharmacology for alendronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Medical Subject Heading (MeSH) Categories for alendronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
MylanALENDRONATE SODIUMalendronate sodiumTABLET;ORAL078638-002Aug 4, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
MylanALENDRONATE SODIUMalendronate sodiumTABLET;ORAL076584-001Aug 4, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla LtdALENDRONATE SODIUMalendronate sodiumTABLET;ORAL076768-001Aug 4, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla LtdALENDRONATE SODIUMalendronate sodiumTABLET;ORAL076768-003Aug 4, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-005Oct 20, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
Teva PharmsALENDRONATE SODIUMalendronate sodiumTABLET;ORAL076184-002Aug 4, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs IncALENDRONATE SODIUMalendronate sodiumTABLET;ORAL075710-004Feb 6, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
ApotexALENDRONATE SODIUMalendronate sodiumTABLET;ORAL077982-004Aug 4, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Upsher-smith LabsALENDRONATE SODIUMalendronate sodiumTABLET;ORAL075871-002Apr 22, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson LabsALENDRONATE SODIUMalendronate sodiumTABLET;ORAL076984-002Aug 4, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: alendronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-004Oct 20, 2000► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-003Apr 25, 1997► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-001Sep 29, 1995► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-002Sep 29, 1995► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-005Oct 20, 2000► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-004Oct 20, 2000► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-004Oct 20, 2000► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-005Oct 20, 2000► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-001Sep 29, 1995► Subscribe► Subscribe
Merck And Co IncFOSAMAXalendronate sodiumTABLET;ORAL020560-005Oct 20, 2000► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: alendronate sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,333,316 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
8,449,906Effervescent compositions comprising phosphonates and methods related thereto► Subscribe
6,465,443 Method for inhibiting bone resorption► Subscribe
6,432,932 Method for inhibiting bone resorption► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: alendronate sodium

Country Document Number Estimated Expiration
European Patent Office0998292► Subscribe
European Patent Office1490024► Subscribe
Eurasian Patent Organization004544► Subscribe
Canada2349744► Subscribe
Slovakia932000► Subscribe
China1166365► Subscribe
United Kingdom9819243► Subscribe
Yugoslavia1800► Subscribe
Iceland5315► Subscribe
Germany69803291► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ALENDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
222Luxembourg► Subscribe91222, EXPIRES: 20200824
2006002,C0998292Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
00292Netherlands► SubscribePRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
2007 00045Denmark► Subscribe
2006002Lithuania► SubscribePRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
364Luxembourg► Subscribe91364, EXPIRES: 20200826
2007007Lithuania► SubscribePRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2006 00005Denmark► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
US Department of Justice
Teva
Colorcon
Fish and Richardson
Baxter
Queensland Health
UBS
Accenture
QuintilesIMS

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot