FOSAMAX Drug Patent Profile

When do Fosamax patents expire, and what generic alternatives are available?

Fosamax is a drug marketed by Merck, Organon, and Organon Llc. and is included in three NDAs.

The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Summary for FOSAMAX

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	171
Clinical Trials:	63
Patent Applications:	3,340
Drug Prices:	Drug price information for FOSAMAX
Drug Sales Revenues:	Drug sales revenues for FOSAMAX
What excipients (inactive ingredients) are in FOSAMAX?	FOSAMAX excipients list
DailyMed Link:	FOSAMAX at DailyMed

See drug prices for FOSAMAX

See drug sales revenues for FOSAMAX

Recent Clinical Trials for FOSAMAX

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

Sponsor	Phase
Doris Duke Charitable Foundation	Phase 2
University of California, Davis	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2

See all FOSAMAX clinical trials

Pharmacology for FOSAMAX

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for FOSAMAX

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 FOSAMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003		DISCN	Yes	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	020560-004	Oct 20, 2000		DISCN	Yes	No
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007		RX	Yes	Yes
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997		DISCN	Yes	No
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995		DISCN	Yes	No

Expired US Patents for FOSAMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000

International Patents for FOSAMAX

See the table below for patents covering FOSAMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	01201913
European Patent Office	0809503
Slovenia	0998292
Eurasian Patent Organization	000348	СПОСОБ УМЕНЬШЕНИЯ РИСКА ВЕРТЕБРАЛЬНЫХ ПЕРЕЛОМОВ (METHOD OF LESSENING THE RISK OF VERTEBRAL FRACTURES)
Greece	3034936
European Patent Office	1151752

Supplementary Protection Certificates for FOSAMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0998292	CA 2006 00005	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904	91364	Luxembourg		91364, EXPIRES: 20200826
1175904	C01175904/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
1175904	PA2007007	Lithuania		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
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0998292	91222	Luxembourg		91222, EXPIRES: 20200824