.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Alendronate sodium - Generic Drug Details

« Back to Dashboard
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, Jubilant Cadista, 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
Sandoz
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL075871-004Apr 22, 2009DISCNNo<disabled><disabled>
Mylan
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL076584-003Aug 4, 2008RXNo<disabled><disabled>
Merck
FOSAMAX
alendronate sodium
SOLUTION;ORAL021575-001Sep 17, 2003RXYes6,015,801*PED<disabled>Y<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: alendronate sodium

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-003Apr 25, 19975,849,726*PED<disabled>
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, 19954,621,077*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
6,465,443 Method for inhibiting bone resorption<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: alendronate sodium

Country Document Number Estimated Expiration
European Patent Office1132088<disabled in preview>
Israel133535<disabled in preview>
Spain2269014<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ALENDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002Lithuania<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
1175904/01Switzerland<disabled>FORMER OWNER: SCHERING CORPORATION, US
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc