FOSAMAX PLUS D Drug Patent Profile

Which patents cover Fosamax Plus D, 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:	62
Patent Applications:	11
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
424 General Military Hospital	Phase 4
Aristotle University Of Thessaloniki	Phase 4
Yonsei University	Phase 4

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	021762-002	Apr 26, 2007
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
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	021762-001	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
Luxembourg	91364
Austria	357921
Slovakia	282100
Canada	2294595	INHIBITION DE RESORPTION OSSEUSE (INHIBITING BONE RESORPTION)
Australia	5611594

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	91364	Luxembourg		91364, EXPIRES: 20200826
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
0998292	PA2006002,C0998292	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	C300292	Netherlands		PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826