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Last Updated: September 26, 2022

Alendronate sodium - Generic Drug Details


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What are the generic drug 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
Apotex ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 077982-001 Aug 4, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Picket Pharms ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 079049-002 Aug 4, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076584-004 Aug 4, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076984-001 Aug 4, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090022-003 Sep 10, 2008 AB RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 See Plans and Pricing See Plans and Pricing
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 See Plans and Pricing See Plans and Pricing
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 See Plans and Pricing See Plans and Pricing
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 See Plans and Pricing See Plans and Pricing
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 See Plans and Pricing See Plans and Pricing
>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 102011505 See Plans and Pricing
Russian Federation 2013109765 СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ See Plans and Pricing
South Korea 20180115254 신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) See Plans and Pricing
Spain 2380924 See Plans and Pricing
China 103140220 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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McKesson
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Dow
McKinsey
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Harvard Business School

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.