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Last Updated: December 2, 2022

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, Merck, Ascend Theraps Us, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Picket Pharms, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in eighteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has thirty-one patent family members in seventeen countries.

There are eighteen drug master file entries for alendronate sodium. Nineteen 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

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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
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090124-003 Aug 4, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 075871-004 Apr 22, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 075871-002 Apr 22, 2009 DISCN No No See Plans and Pricing See Plans and Pricing 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

Expired US Patents for alendronate sodium

International Patents for alendronate sodium

Country Patent Number Title Estimated Expiration
Spain 2380924 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004035004 See Plans and Pricing
World Intellectual Property Organization (WIPO) 03075884 See Plans and Pricing
Poland 2648702 See Plans and Pricing
Israel 224367 תכשירי ביספוספונט יציבים תוססים עם תכונות מסיסות מהירה (Stable effervescent bisphosphonate formulations with rapid solubilization characteristics) See Plans and Pricing
Australia 2011338674 Stable effervescent bisphosphonate formulations with rapid solubilization characteristics See Plans and Pricing
>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 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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