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Last Updated: March 8, 2021

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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, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Neopharma, Sun Pharm, Teva Pharms, Upsher Smith Labs, Watson Labs, and Merck And Co Inc, and is included in eighteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has eleven patent family members in seven countries.

There are twenty-five drug master file entries for alendronate sodium. Twenty-one 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
Peking Union Medical College HospitalPhase 4
CSPC Ouyi Pharmaceutical Co., Ltd.Phase 4
University of BaghdadPhase 1/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 NDA Submissiondate
FOSAMAX SOLUTION;ORAL alendronate sodium 021575 2007-09-07
FOSAMAX TABLET;ORAL alendronate sodium 020560

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
Neopharma ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 079049-001 Aug 4, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 078638-001 Aug 4, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Jubilant Cadista ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090557-004 Feb 18, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090124-003 Aug 4, 2008 AB RX No No   Start Trial   Start Trial   Start 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
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000   Start Trial   Start Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995   Start Trial   Start Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995   Start Trial   Start Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for alendronate sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium   Start 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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Serving leading biopharmaceutical companies globally:

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Medtronic

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