Viewing data from:

FOSAMAX

NDA

ALENDRONATE SODIUM | N020560 | ORGANON LLC A SUB OF ORGANON AND CO

5 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Clinipace Worldwide FDA-2014-P-0861 · 5 docket documents Clinipace Worldwide filed this citizen petition on behalf of a client requesting that the FDA determine whether Merck's discontinued FOSAMAX (alendronate sodium) tablets in 10 mg, 35 mg, and 40 mg strengths under NDA 20560 were withdrawn for reasons of safety or effectiveness, and if not, to accept	505(q)	2014-07-02	Granted	Clinipace Worldwide

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

131 trials from ClinicalTrials.gov, 1 active, 106 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparative Antiresorptive Efficacy Discontinuation of Denosumab NCT03623633	Phase 4	Active	Massachusetts General Hospital	51	2018-11-30 → 2023-08-01
Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients NCT00136058	Phase 3	Completed	University of Alberta	250	2002-01 → 2006-04
Sodium Alendronate in Non Surgical Periodontal Therapy NCT02470611	Phase 4	Completed	Federal University of Minas Gerais	32	2012-11 → 2014-11
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study NCT03292146	Phase 3	Completed	Massachusetts General Hospital	30	2017-10-25 → 2021-07-22
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.NCT00330460	Phase 3	Completed	Amgen	1,189	2006-05 → 2008-01
Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial NCT00354302	Phase 3	Completed	NCIC Clinical Trials Group	497	2006-04-24 → 2012-01-06
Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects NCT00666627	Phase 2	Completed	Sheffield Teaching Hospitals NHS Foundation Trust	410	2007-04 → 2014-12
MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)NCT00996801	Phase 2	Completed	Merck Sharp & Dohme LLC	526	2009-11 → 2011-06
Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis NCT00010439	Phase 2	Completed	Medical University of South Carolina	10	2000-09 → 2008-11
EVA: Evista Alendronate Comparison NCT00035971	Phase 4	Completed	Eli Lilly and Company	—	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$38.70

per ea

Lowest NADAC/Unit

$38.70

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206013501FOSAMAX 70 MG TABLET	$38.70	EA	Brand	$0.2598	2026-01-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$111.70

Highest Price

$152.15

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0135-01FOSAMAX 70MG TAB	$152.15	FSS	Organon LLC	01/14/2027
78206-0135-01FOSAMAX 70MG TAB	$111.70	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 (2024)

Total Spending

$446K

Total Claims

1,437

Beneficiaries

459

Avg Cost/Unit

$34.22

Spending Trend

$132K(2021)→$477K(2022)→$449K(2023)→$446K(2024)

YoY Change:-5.2%

5yr CAGR:+2.7%

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

API Supply Chain10 active DMFs8 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDALENDRONATE SODIUM USP

DMF 143341999

APOTEX INCALENDRONATE SODIUM TRIHYDRATE USP

DMF 154092001

APITORIA PHARMA PRIVATE LTDALENDRONATE SODIUM USP (NON-STERILE DRUG SUBSTANCE)

DMF 200312006

DR REDDYS LABORATORIES LTDALENDRONATE SODIUM

DMF 201002006

MATRIX PHARMACORP PRIVATE LTDALENDRONATE SODIUM USP (TRIHYDRATE)

DMF 204022007

ORCHID PHARMA LTDALENDRONATE SODIUM TRIHYDRATE

DMF 204152007

SUN PHARMACEUTICAL INDUSTRIES LTDALENDRONATE SODIUM USP

DMF 207862007

IPCA LABORATORIES LTDALENDRONATE SODIUM USP

DMF 210082007

JUBILANT BIOSYS LTDALENDRONATE SODIUM USP

DMF 223332009

MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDALENDRONATE SODIUM

DMF 261092012

ALCHYMARS SPAInactiveALENDRONATE SODIUM

DMF 149832000

SIGNA SA DE CVInactiveALENDRONATE SODIUM TRIHYDRATE USP

DMF 161292002

MEDICHEM SAInactiveALENDRONATE SODIUM

DMF 163672003

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveALENDRONATE SODIUM USP 28

DMF 185772005

LUPIN LTDInactiveALENDRONATE SODIUM USP

DMF 192992006

ALEMBIC PHARMACEUTICALS LTDInactiveALENDRONATE SODIUM USP

DMF 206512007

CHONGQING CARE LIFE PHARMACEUTICAL CO LTDInactiveALENDRONATE SODIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 231692009

CTX LIFE SCIENCES PVT LTDInactiveALENDRONATE SODIUM USP

DMF 258282012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

37 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2026	SUPPL -73	View Letter (PDF)
Aug 20, 2019	SUPPL -70	View Letter (PDF)
Dec 1, 2015	SUPPL -69	View Letter (PDF)
Apr 13, 2015	SUPPL -68	View Letter (PDF)
Dec 26, 2013	SUPPL -66	View Letter (PDF)
Apr 23, 2013	SUPPL -65	View Letter (PDF)
Jun 28, 2012	SUPPL -62	View Letter (PDF)
Feb 8, 2012	SUPPL -56	View Letter (PDF)
Jul 6, 2011	SUPPL -61	View Letter (PDF)
Jan 28, 2011	SUPPL -60	View Letter (PDF)
Mar 5, 2010	SUPPL -57	View Letter (PDF)
Mar 5, 2010	SUPPL -51	View Letter (PDF)
Mar 5, 2010	SUPPL -55	View Letter (PDF)
Oct 9, 2008	SUPPL -52	View Letter (PDF)
Jan 8, 2007	SUPPL -48	View Letter (PDF)
Jan 8, 2007	SUPPL -47	View Letter (PDF)
Jan 6, 2006	SUPPL -38	View Letter (PDF)
Nov 8, 2005	SUPPL -46	View Letter (PDF)
Dec 8, 2004	SUPPL -44	View Letter (PDF)
Dec 8, 2004	SUPPL -43	View Letter (PDF)
Apr 29, 2004	SUPPL -30	View Letter (PDF)
Apr 20, 2004	SUPPL -41	View Letter (PDF)
Mar 3, 2004	SUPPL -42	View Letter (PDF)
Sep 29, 2003	SUPPL -40	View Letter (PDF)
Mar 26, 2003	SUPPL -37	View Letter (PDF)
Sep 16, 2002	SUPPL -28	View Letter (PDF)
Aug 13, 2002	SUPPL -33	View Letter (PDF)
Aug 5, 2002	SUPPL -36	View Letter (PDF)
Jan 31, 2001	SUPPL -24	View Letter (PDF)
Jan 31, 2001	SUPPL -25	View Letter (PDF)
Oct 20, 2000	SUPPL -21	View Letter (PDF)
Oct 20, 2000	SUPPL -22	View Letter (PDF)
Sep 29, 2000	SUPPL -23	View Letter (PDF)
Nov 24, 1999	SUPPL -15	View Letter (PDF)
Nov 24, 1999	SUPPL -18	View Letter (PDF)
Jun 16, 1999	SUPPL -12	View Letter (PDF)
Jun 8, 1999	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 29, 1995

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 29, 1995

#003 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 25, 1997

#004 — EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 20, 2000

#005 — EQ 70MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 20, 2000