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.

Summary for alendronate sodium

International Patents:	11
US Patents:	2
Tradenames:	4
Applicants:	16
NDAs:	18
Drug Master File Entries:	25
Suppliers / Packagers:	21
Bulk Api Vendors:	41
Clinical Trials:	27
Patent Applications:	23
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for alendronate sodium
Drug Sales Revenues:	Drug sales revenues for alendronate sodium
What excipients (inactive ingredients) are in alendronate sodium?	alendronate sodium excipients list
DailyMed Link:	alendronate sodium at DailyMed

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Drug Sales Revenue Trends for alendronate sodium

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Recent Clinical Trials for alendronate sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking Union Medical College Hospital	Phase 4
CSPC Ouyi Pharmaceutical Co., Ltd.	Phase 4
University of Baghdad	Phase 1/Phase 2

See all alendronate sodium clinical trials

Pharmacology for alendronate sodium

Drug Class	Bisphosphonate

Medical Subject Heading (MeSH) Categories for alendronate sodium

Bone Density Conservation Agents

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

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Glossary

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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

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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

International Patents for alendronate sodium

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Country	Patent Number	Estimated Expiration
Canada	2495886	Start Trial
Denmark	1490024	Start Trial
Spain	2448501	Start Trial
European Patent Office	1490024	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for alendronate sodium

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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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