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Alendronate sodium - Generic Drug Details

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

This ingredient has ninety-five patent family members in forty countries.

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

Summary for Generic Name: alendronate sodium

Tradenames:4
Patents:5
Applicants:15
NDAs:19
Drug Master File Entries: see list25
Suppliers / Packaging: see list29
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: alendronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: alendronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL090124-002Aug 4, 2008RXNo<disabled><disabled>
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-001Apr 7, 2005DISCNNo5,994,329*PED<disabled>Y<disabled>
Aurobindo Pharma
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL090124-003Aug 4, 2008RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: alendronate sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 19976,008,207*PED<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 19976,090,410*PED<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-001Sep 29, 19956,090,410*PED<disabled>
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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
8,449,906Effervescent compositions comprising phosphonates and methods related thereto<disabled in preview>
6,465,443 Method for inhibiting bone resorption<disabled in preview>
6,333,316 Method for inhibiting bone resorption<disabled in preview>
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International Patent Family for Ingredient: alendronate sodium

Country Document Number Estimated Expiration
Ukraine67748<disabled in preview>
Portugal1175904<disabled in preview>
TaiwanI226833<disabled in preview>
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Supplementary Protection Certificates for Tradename: ALENDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002,C0998292Lithuania<disabled>PRODUCT 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
2007 00045Denmark<disabled>
2006 00005Denmark<disabled>
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