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FOSAMAX PLUS D

NDA

ALENDRONATE SODIUM; CHOLECALCIFEROL | N021762 | ORGANON LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)NCT00092066	Phase 3	Completed	Organon and Co	717	2003-09-24 → 2004-05-01
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D NCT00806416	Phase 1	Completed	Organon and Co	244	2003-05 → 2004-01
A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)NCT00092079	Phase 3	Completed	Merck Sharp & Dohme LLC	652	2004-01 → 2004-11
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)NCT00641771	Phase 1	Completed	Organon and Co	56	2004-05 → 2005-08
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)NCT00729651	Phase 4	Completed	Organon and Co	343	2008-03-20 → 2009-04-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$52.73

per ea

Lowest NADAC/Unit

$52.65

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206013701FOSAMAX PLUS D 70 MG-2800 UNIT	$52.73	EA	Brand	—	2026-01-01
78206013601FOSAMAX PLUS D 70 MG-5600 UNIT	$52.65	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$150.41

Highest Price

$206.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0136-01FOSAMAX PLUS D	$206.29	FSS	Organon LLC	01/14/2027
78206-0136-01FOSAMAX PLUS D	$151.09	Big4	Organon LLC	01/14/2027
78206-0137-01FOSAMAX PLUS D	$206.29	FSS	Organon LLC	01/14/2027
78206-0137-01FOSAMAX PLUS D	$150.41	Big4	Organon LLC	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Fosamax Plus D (2024)

Total Spending

$535K

Total Claims

1,838

Beneficiaries

580

Avg Cost/Unit

$49.64

Spending Trend

$166K(2021)→$663K(2022)→$604K(2023)→$535K(2024)

YoY Change:-1.8%

5yr CAGR:+4.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2026	SUPPL -27	View Letter (PDF)
Aug 20, 2019	SUPPL -22	View Letter (PDF)
Dec 1, 2015	SUPPL -21	View Letter (PDF)
Apr 13, 2015	SUPPL -20	View Letter (PDF)
Nov 8, 2013	SUPPL -18	View Letter (PDF)
Apr 23, 2013	SUPPL -17	View Letter (PDF)
Jul 6, 2011	SUPPL -15	View Letter (PDF)
Jan 27, 2011	SUPPL -13	View Letter (PDF)
Mar 3, 2010	SUPPL -9	View Letter (PDF)
Mar 3, 2010	SUPPL -5	View Letter (PDF)
Mar 3, 2010	SUPPL -10	View Letter (PDF)
Oct 9, 2008	SUPPL -6	View Letter (PDF)
May 1, 2007	SUPPL -4	View Letter (PDF)
Jan 8, 2007	SUPPL -2	View Letter (PDF)
Jan 8, 2007	SUPPL -3	View Letter (PDF)
Nov 8, 2005	SUPPL -1	View Letter (PDF)
Apr 12, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 70MG BASE;2,800 IU

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 7, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 70MG BASE;5,600 IU

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 26, 2007