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Last Updated: April 22, 2024

Alendronate sodium - Generic Drug Details


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What are the generic sources for alendronate sodium and what is the scope of patent protection?

Alendronate sodium is the generic ingredient in four branded drugs marketed by Hikma, Novitium Pharma, Merck, Radius, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in nineteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has twenty patent family members in sixteen countries.

There are eighteen drug master file entries for alendronate sodium. Twenty suppliers are listed for this compound.

Drug Prices for alendronate sodium

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Drug Sales Revenue Trends for alendronate sodium

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Recent Clinical Trials for alendronate sodium

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SponsorPhase
Aristotle University Of ThessalonikiPhase 4
424 General Military HospitalPhase 4
Shanghai JMT-Bio Inc.Phase 2

See all alendronate sodium clinical trials

Pharmacology for alendronate sodium
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for alendronate sodium
Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOSAMAX Oral Solution alendronate sodium 70 mg/75 mL 021575 1 2007-09-07

US Patents and Regulatory Information 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
Rising ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076584-003 Aug 4, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hangzhou Binjiang ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090258-002 Sep 24, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090022-003 Sep 10, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090124-001 Aug 4, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 075871-002 Apr 22, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076768-003 Aug 4, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for alendronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for alendronate sodium

Country Patent Number Title Estimated Expiration
South Korea 20140075638 STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2012078528 ⤷  Try a Trial
Australia 2011338674 Stable effervescent bisphosphonate formulations with rapid solubilization characteristics ⤷  Try a Trial
Canada 2820019 FORMULATIONS EFFERVESCENTES STABLES A BASE DE BISPHOSPHONATE PRESENTANT DES CARACTERISTIQUES DE SOLUBILISATION RAPIDE (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) ⤷  Try a Trial
Spain 2716525 ⤷  Try a Trial
South Korea 102011505 ⤷  Try a Trial
European Patent Office 2648702 FORMULATIONS EFFERVESCENTES STABLES À BASE DE BISPHOSPHONATE PRÉSENTANT DES CARACTÉRISTIQUES DE SOLUBILISATION RAPIDE (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for alendronate sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium ⤷  Try a 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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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.