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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, Impax Labs Inc, Roxane, Sun Pharma Global, Aurobindo Pharma, Mylan, Mission Pharma, Jubilant Cadista, Austarpharma Llc, Merck And Co Inc, Cipla Ltd, Sandoz, Merck, Apotex, Teva Pharms, 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:16
NDAs:19
Drug Master File Entries: see list25
Suppliers / Packaging: see list29
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Impax Labs Inc
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL075710-004Feb 6, 2008RXNo
Sandoz
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL075871-002Apr 22, 2009DISCNNo
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 2003DISCNNo5,994,329*PEDJan 17, 2019Y
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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;ORAL020560-001Sep 29, 19955,849,726*PED<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-002Sep 29, 19955,804,570<disabled>
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-005Oct 20, 20006,090,410*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>
6,333,316 Method for inhibiting bone resorption<disabled in preview>
6,432,932 Method for inhibiting bone resorption<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: alendronate sodium

Country Document Number Estimated Expiration
New Zealand501807<disabled in preview>
South Korea100391732<disabled in preview>
Iceland7231<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ALENDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00045Denmark<disabled>
2007007Lithuania<disabled>PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
2006 00005Denmark<disabled>
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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 verifification 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.

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