Alendronate sodium - Generic Drug Details

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, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Picket Pharms, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in eighteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has thirty-one patent family members in seventeen countries.

There are eighteen drug master file entries for alendronate sodium. Nineteen suppliers are listed for this compound.

Summary for alendronate sodium

International Patents:	31
US Patents:	3
Tradenames:	4
Applicants:	18
NDAs:	18
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	38
Patent Applications:	7,032
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

See drug prices for alendronate sodium

See drug sales revenues for alendronate sodium

Recent Clinical Trials for alendronate sodium

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

Sponsor	Phase
Aristotle University Of Thessaloniki	Phase 4
424 General Military Hospital	Phase 4
Shanghai JMT-Bio Inc.	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	Strength	NDA	ANDAs Submitted	Submissiondate
FOSAMAX	Oral Solution	alendronate sodium	70 mg/75 mL	021575	1	2007-09-07

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
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007		RX	Yes	Yes
Aurobindo Pharma	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090124-003	Aug 4, 2008	AB	RX	No	No
Chartwell Rx	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	075871-004	Apr 22, 2009		DISCN	No	No
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005		RX	Yes	No
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995		DISCN	Yes	No
Chartwell Rx	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	075871-002	Apr 22, 2009		DISCN	No	No

Expired US Patents for alendronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000

International Patents for alendronate sodium

Country	Patent Number	Title	Estimated Expiration
Spain	2380924
World Intellectual Property Organization (WIPO)	2004035004
World Intellectual Property Organization (WIPO)	03075884
Poland	2648702
Israel	224367	תכשירי ביספוספונט יציבים תוססים עם תכונות מסיסות מהירה (Stable effervescent bisphosphonate formulations with rapid solubilization characteristics)
Australia	2011338674	Stable effervescent bisphosphonate formulations with rapid solubilization characteristics

Supplementary Protection Certificates for alendronate sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826