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
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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
Doris Duke Charitable Foundation	Phase 2
University of California, Davis	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	6,090,410*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	6,090,410*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	4,621,077*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	5,358,941*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	4,621,077*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	5,994,329*PED
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-001	Apr 7, 2005	5,681,590*PED

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
Indonesia	24096
China	1919200
Japan	S58189193	PHARMACOLOGICAL BIPHOSPHONATE, MANUFACTURE AND MEDICINE
Turkey	200000145
South Korea	20030096426
Japan	2003073277	DRY MIX FORMULATION FOR BISPHOSPHONIC ACID
Malaysia	118194	PHARMACEUTICAL COMPOSITIONS FOR USE IN INHIBITING BONE RESORPTION

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0998292	CA 2006 00005	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904	91364	Luxembourg		91364, EXPIRES: 20200826
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
0998292	91222	Luxembourg		91222, EXPIRES: 20200824
1175904	CA 2007 00045	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL

FOSAMAX PLUS D Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FOSAMAX PLUS D

Introduction

FOSAMAX PLUS D, a combination drug containing alendronate and vitamin D3, is a significant player in the osteoporosis treatment market. This article delves into the market dynamics, financial trajectory, and other key aspects of FOSAMAX PLUS D.

Market Size and Growth

The global osteoporosis treatment market, within which FOSAMAX PLUS D operates, is substantial and growing. As of 2024, the market size was estimated at USD 12.79 billion and is projected to reach USD 20.83 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2034[3].

Regional Market Presence

The North American market, particularly the U.S., is a major segment for FOSAMAX PLUS D. The U.S. osteoporosis treatment market was valued at USD 3.50 billion in 2023 and is expected to grow to USD 6.12 billion by 2034, with a CAGR of 5.2% from 2024 to 2034[3].

Drug Class and Market Share

FOSAMAX PLUS D belongs to the bisphosphonate class of drugs, which holds a significant share in the osteoporosis treatment market. Bisphosphonates, including alendronate and zoledronic acid, are widely adopted due to their efficacy in inhibiting bone resorption, enhancing bone density, and reducing fracture risks. This class of drugs has a well-established reputation, extensive clinical history, and regulatory approvals, making them a favored choice among healthcare professionals[3].

Competitive Landscape

The osteoporosis treatment market is competitive, with various drug classes such as hormone replacement therapy, selective estrogen receptor modulators (SERMs), and RANK ligand (RANKL) inhibitors. However, bisphosphonates, including FOSAMAX PLUS D, remain a dominant force due to their cost-effectiveness, comprehensive insurance coverage, and availability in both oral and intravenous formulations[3].

Regulatory and Clinical Aspects

FOSAMAX PLUS D is indicated for the treatment of osteoporosis in postmenopausal women and men, where vitamin D supplementation is recommended. The recommended dosage is one 70 mg alendronate/2800 or 5600 international units vitamin D3 tablet once weekly. The optimal duration of use has not been determined, and patients should be re-evaluated periodically for the need for continued therapy[1][4].

Safety and Efficacy

Clinical trials have demonstrated the efficacy of FOSAMAX PLUS D in increasing bone mass and reducing the incidence of fractures. For instance, in the Four-Year Study of FIT, FOSAMAX reduced the percentage of osteoporotic women experiencing multiple vertebral fractures from 0.6% to 0.1%[2].

However, like other bisphosphonates, FOSAMAX PLUS D is associated with potential side effects such as osteonecrosis of the jaw (ONJ), which is generally linked to invasive dental procedures and other risk factors[1].

Litigation and Legal Challenges

Merck, the manufacturer of FOSAMAX PLUS D, has faced several legal challenges related to the drug. Despite these, the company has won several key trials, including the first state court case in the coordinated N.J. FOSAMAX litigation. These legal outcomes have supported Merck's stance that the company acted responsibly in researching and developing FOSAMAX[2].

Financial Performance and Projections

The financial performance of FOSAMAX PLUS D is closely tied to the overall osteoporosis treatment market. With the market expected to grow significantly over the next decade, FOSAMAX PLUS D is likely to continue generating substantial revenue. The cost-effectiveness and widespread adoption of bisphosphonates contribute to their financial viability and market dominance[3].

Integration of Digital Health Solutions

The osteoporosis treatment market, including FOSAMAX PLUS D, is benefiting from the integration of digital health solutions. These solutions enhance patient management, improve adherence to treatment, and provide valuable data for healthcare providers and pharmaceutical companies. This trend is expected to continue, driving innovation and efficiency in the market[3].

Challenges and Opportunities

Despite the promising trajectory, the osteoporosis treatment market faces challenges such as rigorous regulatory prerequisites for drug approvals and the need for long-term clinical data. However, these challenges also present opportunities for pharmaceutical companies and biotechnology enterprises to pioneer innovative treatments and diagnostics, potentially leading to improved patient outcomes and cost-efficiency[3].

Key Takeaways

• Market Growth: The global osteoporosis treatment market is expected to grow from USD 12.79 billion in 2024 to USD 20.83 billion by 2034.
• Regional Presence: The U.S. market is a significant segment, with a projected growth from USD 3.50 billion in 2023 to USD 6.12 billion by 2034.
• Drug Class Dominance: Bisphosphonates, including FOSAMAX PLUS D, dominate the market due to their efficacy and cost-effectiveness.
• Regulatory and Clinical Aspects: FOSAMAX PLUS D is indicated for osteoporosis treatment with specific dosing and safety guidelines.
• Financial Performance: The drug's financial performance is strong and expected to continue growing with the market.

FAQs

What is FOSAMAX PLUS D used for?

FOSAMAX PLUS D is used for the treatment of osteoporosis in postmenopausal women and men, where vitamin D supplementation is recommended.

What is the recommended dosage of FOSAMAX PLUS D?

The recommended dosage is one 70 mg alendronate/2800 or 5600 international units vitamin D3 tablet once weekly.

What are the potential side effects of FOSAMAX PLUS D?

Potential side effects include osteonecrosis of the jaw (ONJ), which is generally associated with invasive dental procedures and other risk factors.

How does FOSAMAX PLUS D compare to other osteoporosis treatments?

FOSAMAX PLUS D, as a bisphosphonate, is widely adopted due to its efficacy, cost-effectiveness, and comprehensive insurance coverage.

What is the projected market growth for FOSAMAX PLUS D?

The global osteoporosis treatment market, which includes FOSAMAX PLUS D, is expected to grow from USD 12.79 billion in 2024 to USD 20.83 billion by 2034.

Sources

1. FOSAMAX® PLUS D Label - accessdata.fda.gov
2. Merck Wins First FOSAMAX® (alendronate sodium) State Court Trial - merck.com
3. Osteoporosis Treatment Market Size, Growth, Report By 2034 - precedenceresearch.com
4. NEW ZEALAND DATA SHEET 1 FOSAMAX PLUS™ 70 - medsafe.govt.nz