FOSAMAX Drug Patent Profile

When do Fosamax patents expire, and what generic alternatives are available?

Fosamax is a drug marketed by Merck, Organon, and Organon Llc. and is included in three NDAs.

The generic ingredient in FOSAMAX 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

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	171
Clinical Trials:	63
Patent Applications:	3,646
Drug Prices:	Drug price information for FOSAMAX
Drug Sales Revenues:	Drug sales revenues for FOSAMAX
What excipients (inactive ingredients) are in FOSAMAX?	FOSAMAX excipients list
DailyMed Link:	FOSAMAX at DailyMed

See drug prices for FOSAMAX

See drug sales revenues for FOSAMAX

Recent Clinical Trials for FOSAMAX

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 clinical trials

Pharmacology for FOSAMAX

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for FOSAMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOSAMAX	Oral Solution	alendronate sodium	70 mg/75 mL	021575	1	2007-09-07

US Patents and Regulatory Information for FOSAMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000		DISCN	Yes	No
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003		DISCN	Yes	No
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	5,358,941*PED
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	6,225,294*PED
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995	5,804,570
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	6,194,004*PED

International Patents for FOSAMAX

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20000035
Hungary	9501590
Singapore	139556	METHOD FOR INHIBITING BONE RESORPTION
United Kingdom	9819243

Supplementary Protection Certificates for FOSAMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1175904	C01175904/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
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	CA 2006 00005	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL

Market Dynamics and Financial Trajectory of FOSAMAX in the Osteoporosis Treatment Market

Introduction

FOSAMAX, a brand name for the drug alendronate, is a prominent bisphosphonate used in the treatment of osteoporosis. This article delves into the market dynamics and financial trajectory of FOSAMAX, highlighting its position within the broader osteoporosis treatment market.

Global Osteoporosis Treatment Market Overview

The global osteoporosis treatment market is experiencing significant growth, driven by factors such as an aging population, increasing prevalence of osteoporosis, and advancements in pharmaceutical innovations. The market size was valued at USD 12.79 billion in 2024 and is projected to reach around USD 20.83 billion by 2034, growing at a CAGR of 4.8% from 2024 to 2034[3].

Market Segmentation and FOSAMAX

Drug Class

FOSAMAX falls under the bisphosphonate category, which is one of the most widely used drug classes for osteoporosis treatment. Bisphosphonates work by inhibiting bone resorption, thereby increasing bone density and reducing the risk of fractures[4].

Market Share and Competition

The bisphosphonate segment, which includes FOSAMAX, is highly competitive with other drugs such as risedronate (Actonel) and ibandronate (Boniva). However, FOSAMAX has maintained a significant market share due to its efficacy and long-standing presence in the market.

Financial Performance of Bisphosphonates

Revenue Trends

The revenue generated by bisphosphonates, including FOSAMAX, has been substantial. Although the market has seen a shift towards generic versions as patents expire, branded bisphosphonates continue to contribute significantly to the overall revenue. For instance, the global osteoporosis drugs market, which includes bisphosphonates, was valued at USD 14.74 billion in 2023 and is projected to grow at a CAGR of 3.5% from 2024 to 2030[5].

Impact of Generic Versions

The expiration of patents for branded bisphosphonates has led to the emergence of generic versions, which are gaining popularity due to their lower costs. This trend has affected the revenue of branded drugs like FOSAMAX but has not diminished their importance in the treatment regimen. Generic versions are expected to grow at a CAGR of 4.9% in the forthcoming years, driven by cost-effectiveness and government regulations promoting their use[5].

Regional Market Dynamics

North America

The North American market, particularly the U.S., is a significant contributor to the osteoporosis treatment market. The U.S. osteoporosis treatment market size was estimated at USD 3.50 billion in 2023 and is predicted to grow at a CAGR of 5.2% from 2024 to 2034. FOSAMAX has a strong presence in this region due to its established brand and widespread use[3].

Europe and Other Regions

Europe is another key region for the osteoporosis treatment market, with new drug launches and active government support contributing to its growth. Economically developing countries such as China and India are also becoming major contributors to the healthcare expenditure, driving the growth of the osteoporosis treatment market in these regions[1].

Distribution Channels

The distribution of FOSAMAX and other osteoporosis drugs is segmented into hospital pharmacies, retail pharmacies & stores, and online pharmacies. Hospital pharmacies are experiencing growth due to an increase in patients visiting hospitals for osteoporosis treatment, while retail pharmacies & stores are expanding through partnerships with orthopedic centers and women’s health centers. Online pharmacies are also gaining traction due to the convenience of online drug purchases[1].

Technological Advancements

While FOSAMAX is a well-established drug, the osteoporosis treatment market is witnessing several technological trends that could impact its future. Novel drug delivery systems, including nanotechnology-based formulations and targeted drug delivery systems, are being developed to enhance the bioavailability and efficacy of osteoporosis medications. These advancements could influence the market dynamics and potentially affect the sales of traditional bisphosphonates like FOSAMAX[4].

Key Players and Market Strategies

Companies like Merck & Co., the manufacturer of FOSAMAX, are focusing on strategic business development, including acquisitions and partnerships, to augment their pipeline and maintain market share. For example, Merck’s strong revenue growth in 2022 was driven by its pharmaceutical segment, which includes drugs like KEYTRUDA and GARDASIL, although FOSAMAX is not as prominently featured in recent financial reports due to the rise of other therapeutic areas[2].

Financial Trajectory

Historical Revenue

Historical data on FOSAMAX's revenue is not as readily available in recent reports due to the dominance of other Merck products. However, it is known that bisphosphonates, as a class, have contributed significantly to the osteoporosis treatment market.

Future Outlook

The future financial trajectory of FOSAMAX will likely be influenced by the growing competition from generic versions and new drug classes such as RANK ligand inhibitors and selective estrogen receptor modulators (SERMs). Despite this, FOSAMAX is expected to maintain a stable market presence due to its established brand and continued use in osteoporosis treatment regimens.

Conclusion

FOSAMAX remains a significant player in the osteoporosis treatment market, despite the evolving landscape of pharmaceutical innovations and the rise of generic versions. The drug's financial trajectory will be shaped by its continued use, competition from new drug classes, and the overall growth of the osteoporosis treatment market.

Key Takeaways

• Market Growth: The global osteoporosis treatment market is projected to grow significantly, driven by an aging population and advancements in pharmaceuticals.
• Bisphosphonates: FOSAMAX, as a bisphosphonate, continues to be a key drug in osteoporosis treatment, though it faces competition from generic versions and new drug classes.
• Regional Dynamics: North America and Europe are major markets for FOSAMAX, with growing contributions from economically developing countries.
• Technological Advancements: Novel drug delivery systems are emerging, which could impact the market dynamics of traditional bisphosphonates.
• Financial Outlook: FOSAMAX's financial trajectory will be influenced by competition and the overall growth of the osteoporosis treatment market.

FAQs

Q1: What is the current market size of the global osteoporosis treatment market? The global osteoporosis treatment market size was valued at USD 12.79 billion in 2024[3].

Q2: What is the projected growth rate of the osteoporosis treatment market from 2024 to 2034? The market is projected to grow at a CAGR of 4.8% from 2024 to 2034[3].

Q3: Which drug class is FOSAMAX part of? FOSAMAX is part of the bisphosphonate drug class[4].

Q4: How is the rise of generic versions affecting the market for branded bisphosphonates like FOSAMAX? The rise of generic versions is leading to significant price decreases and increased demand for generics due to their cost-effectiveness and government regulations promoting their use[5].

Q5: What are some of the technological trends shaping the osteoporosis treatment market? Notable trends include the development of novel drug delivery systems such as nanotechnology-based formulations and targeted drug delivery systems[4].