FOSAMAX PLUS D Drug Patent Profile

When do Fosamax Plus D patents expire, and when can generic versions of Fosamax Plus D launch?

Fosamax Plus D is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in FOSAMAX PLUS D 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 PLUS D

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	63
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FOSAMAX PLUS D
What excipients (inactive ingredients) are in FOSAMAX PLUS D?	FOSAMAX PLUS D excipients list
DailyMed Link:	FOSAMAX PLUS D at DailyMed

See drug prices for FOSAMAX PLUS D

Recent Clinical Trials for FOSAMAX PLUS D

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 PLUS D clinical trials

Pharmacology for FOSAMAX PLUS D

Drug Class

Bisphosphonate Vitamin D

Paragraph IV (Patent) Challenges for FOSAMAX PLUS D

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOSAMAX PLUS D	Tablets	alendronate sodium; cholecalciferol	70 mg/2800 IU and 70 mg/5600 IU	021762	1	2007-11-20

US Patents and Regulatory Information for FOSAMAX PLUS D

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	021762-001	Apr 7, 2005		RX	Yes	No
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007		RX	Yes	Yes

Expired US Patents for FOSAMAX PLUS D

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005

International Patents for FOSAMAX PLUS D

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	661437	BIFOSFONATI FARMACOLOGICAMENTE ATTIVI, PROCEDIMENTO PER LA LORO PREPARAZIONE E RELATIVE COMPOSIZIONI FARMACEUTICHE.
Australia	2005227418
Ukraine	67748	АКТИВНЫЙ ИНГРЕДИЕНТ ДЛЯ ПРОИЗВОДСТВА ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ИНГИБИРОВАНИЯ РЕЗОРБЦИИ КОСТНОЙ ТКАНИ У ЧЕЛОВЕКА (ВАРИАНТЫ);АКТИВНИЙ ІНГРЕДІЄНТ ДЛЯ ВИРОБНИЦТВА ЛІКАРСЬКОГО ЗАСОБУ ДЛЯ ІНГІБУВАННЯ РЕЗОРБЦІЇ КІСТКОВОЇ ТКАНИНИ У ЛЮДИНИ (ВАРІАНТИ) (ACTIVE INGREDIENT FOR PHARMACEUTICAL COMPOSITIONS INTENDED FOR INHIBITING BONE RESORPTION (VARIANTS))

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0998292	PA2006002	Lithuania		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	91364	Luxembourg		91364, EXPIRES: 20200826
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