Alendronate sodium - Generic Drug Details

What are the generic drug sources for alendronate sodium and what is the scope of patent protection?

Alendronate sodium is the generic ingredient in four branded drugs marketed by Hikma, Novitium Pharma, Merck, Radius, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Ipca Labs Ltd, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in twenty NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has twenty patent family members in sixteen countries.

There are eighteen drug master file entries for alendronate sodium. Nineteen suppliers are listed for this compound.

Summary for alendronate sodium

International Patents:	20
US Patents:	1
Tradenames:	4
Applicants:	19
NDAs:	20
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	39
Patent Applications:	167
Drug Prices:	Drug price trends for alendronate sodium
Drug Sales Revenues:	Drug sales revenues for alendronate sodium
What excipients (inactive ingredients) are in alendronate sodium?	alendronate sodium excipients list
DailyMed Link:	alendronate sodium at DailyMed

See drug prices for alendronate sodium

See drug sales revenues for alendronate sodium

Recent Clinical Trials for alendronate sodium

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 alendronate sodium clinical trials

Pharmacology for alendronate sodium

Drug Class

Bisphosphonate

Medical Subject Heading (MeSH) Categories for alendronate sodium

Bone Density Conservation Agents

Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM

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 alendronate sodium

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	020560-005	Oct 20, 2000	AB	RX	Yes	Yes
Apotex	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	077982-003	Aug 4, 2008	AB	RX	No	No
Chartwell Rx	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	075871-004	Apr 22, 2009		DISCN	No	No
Sun Pharm	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090022-004	Sep 10, 2008	AB	RX	No	No
Aurobindo Pharma	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090124-001	Aug 4, 2008	AB	RX	No	No
Sun Pharm	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090022-002	Sep 10, 2008	AB	RX	No	No
Ipca Labs Ltd	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	206387-004	Jun 4, 2024	AB	RX	No	No

Expired US Patents for alendronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995

International Patents for alendronate sodium

Country	Patent Number	Title	Estimated Expiration
Denmark	2648702
South Korea	20180115254	신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS)
Russian Federation	2013109765	СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ
Brazil	112013010476	formulações efervescentes estáveis de bisfosfonato com características de solubilização rápida
Spain	2716525
Canada	2820019	FORMULATIONS EFFERVESCENTES STABLES A BASE DE BISPHOSPHONATE PRESENTANT DES CARACTERISTIQUES DE SOLUBILISATION RAPIDE (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS)
Malaysia	166971	STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS

Supplementary Protection Certificates for alendronate sodium

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

Market Dynamics and Financial Trajectory for Alendronate Sodium

Introduction

Alendronate sodium, a bisphosphonate medication, is a crucial treatment for osteoporosis and other bone-related diseases. The market for this drug is characterized by several key dynamics that influence its growth, competition, and financial trajectory.

Key Drivers of Market Growth

Aging Global Population

The increasing number of elderly individuals worldwide is a significant driver of the alendronate sodium market. As people live longer, the incidence of osteoporosis and other bone-related diseases rises, leading to a higher demand for effective bone health solutions[1][4].

Rising Awareness of Bone Health

Growing awareness about osteoporosis and its complications is prompting more people to seek preventive and therapeutic treatments. Public health initiatives and improving healthcare access in various regions further boost the demand for alendronate sodium tablets[1][4].

Advancements in Drug Formulations

Pharmaceutical companies are continuously developing improved formulations of alendronate sodium, such as once-weekly or once-monthly oral tablets, which enhance patient compliance, reduce side effects, and offer more convenient dosing schedules. These innovations are expanding the market and attracting more patients[1][4].

Government Initiatives and Healthcare Policies

Governments are prioritizing bone health as part of public health initiatives, which drives demand for effective treatments like alendronate sodium. Supportive healthcare policies and subsidies also play a crucial role in making these treatments more accessible[1].

Competitive Landscape

Presence of Generic Alternatives

The expiration of patents for branded alendronate sodium tablets has led to the availability of generic versions, significantly reducing prices and increasing accessibility. This has intensified price competition among manufacturers, potentially limiting profit margins for brand-name drugmakers[1][4].

Innovation and Differentiation

To maintain a competitive edge, pharmaceutical companies are investing in the development of new formulations, extended-release versions, and combination therapies. These innovations aim to provide more effective treatment options, improve patient compliance, and reduce side effects[1][4].

Regional Variations

The competitive dynamics vary by region, with developed markets like North America and Europe accounting for a significant share due to higher healthcare expenditure and greater awareness of osteoporosis. Emerging markets in Asia-Pacific and Latin America are also becoming key players as their healthcare systems improve[1].

Financial Trajectory

Market Size and Projection

The alendronate sodium market is anticipated to grow at a compound annual growth rate (CAGR) from 2024 to 2032, driven by the increasing demand for bone health solutions. The market value is expected to rise significantly, presenting lucrative investment opportunities for both established and emerging companies[3][4].

Investment Opportunities

The growing prevalence of osteoporosis, coupled with advancements in drug formulations and expanding access to healthcare, makes the alendronate sodium market an attractive segment for investment. Pharmaceutical companies are investing heavily in improving existing treatments and exploring novel approaches, such as new bone-forming therapies and advanced delivery methods[1][4].

Strategic Partnerships and Mergers

Strategic partnerships between pharmaceutical companies and research institutions are driving innovation in the bone health sector. Mergers and acquisitions are also reshaping the competitive landscape, as larger companies acquire smaller firms with promising new formulations to expand their portfolios and gain a competitive advantage[1].

Challenges and Considerations

Adverse Effects and Long-Term Use

While alendronate sodium is effective, its long-term use has been associated with certain risks, such as subtrochanteric fractures and osteonecrosis of the jaw. These adverse effects highlight the need for caution and careful monitoring during treatment[2][5].

Price Pressure and Accessibility

The availability of generic versions has increased competition, lowering prices and enhancing accessibility but potentially limiting the profit margins of brand-name drugmakers. This price pressure necessitates a focus on differentiation through innovative formulations and patient-centric solutions[1][4].

Regional Expansion and Emerging Markets

Global Expansion

As healthcare access improves in developing countries, the potential for alendronate sodium in these markets is significant. Pharmaceutical companies are increasing their investments in these regions, where both the prevalence of osteoporosis and the demand for medications are rising[4].

Personalized Medicine

There is a growing emphasis on personalized approaches to osteoporosis treatment, driven by advances in genetic research and patient-specific data. This trend is expected to boost the demand for specialized medications like alendronate sodium trihydrate[4].

Key Takeaways

• The alendronate sodium market is driven by an aging global population, rising awareness of bone health, advancements in drug formulations, and supportive government initiatives.
• The market faces intense competition due to the presence of generic alternatives and new innovations.
• Strategic partnerships, mergers, and acquisitions are crucial for maintaining a competitive edge.
• The market offers significant investment opportunities, particularly in emerging markets and through innovative drug formulations.
• Long-term use of alendronate sodium requires careful monitoring due to potential adverse effects.

Frequently Asked Questions (FAQs)

What are the primary indications for alendronate sodium?

Alendronate sodium is approved by the FDA for the treatment of postmenopausal osteoporosis, steroid-induced osteoporosis, male osteoporosis, and the management of Paget disease of bone[2].

How does alendronate sodium work?

Alendronate sodium belongs to the class of bisphosphonate medications, which prevent bone resorption and promote bone density by binding to hydroxyapatite crystals within bone and downregulating osteoclast-mediated bone reabsorption[2].

What are the common adverse effects of alendronate sodium?

Common adverse effects include transient hypocalcemia, transient hypophosphatemia, GI symptoms, myalgia, joint pain, and other systemic symptoms. Rare but serious adverse effects include osteonecrosis of the jaw and esophageal erosions[2].

How is the competitive landscape of the alendronate sodium market influenced by generic versions?

The presence of generic versions significantly reduces prices and increases accessibility, leading to price competition among manufacturers and potentially limiting profit margins for brand-name drugmakers[1][4].

What are the future investment opportunities in the alendronate sodium market?

The market offers significant investment opportunities due to the growing prevalence of osteoporosis, advancements in drug formulations, and expanding access to healthcare, particularly in emerging markets[1][4].

Cited Sources:

1. Market Research Intellect: "Alendronate Sodium Tablets Market Faces Competitive Landscape as Global Demand for Bone Health Solutions Rises"
2. NCBI Bookshelf: "Alendronate - StatPearls"
3. Wicz: "Alendronate Sodium Market 2024 Size, Share, Growth Factors, Top Leaders, Historical Analysis, Competitive Landscape, and Regional Forecast 2032"
4. Market Research Intellect: "Breaking Down the Alendronate Sodium Trihydrate Market Opportunities in Pharma & Healthcare"
5. Supreme Court of the United States: "In Re: Fosamax (Alendronate Sodium) Product Liability Litigation"