ACTONEL WITH CALCIUM (COPACKAGED) Drug Patent Profile

When do Actonel With Calcium (copackaged) patents expire, and what generic alternatives are available?

Actonel With Calcium (copackaged) is a drug marketed by Warner Chilcott and is included in one NDA.

The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for ACTONEL WITH CALCIUM (COPACKAGED)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	ACTONEL WITH CALCIUM (COPACKAGED) at DailyMed

US Patents and Regulatory Information for ACTONEL WITH CALCIUM (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005		DISCN	Yes	No

Expired US Patents for ACTONEL WITH CALCIUM (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,465,443*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	5,583,122*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,432,932*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,096,342*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,165,513*PED
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005	6,015,801*PED

International Patents for ACTONEL WITH CALCIUM (COPACKAGED)

See the table below for patents covering ACTONEL WITH CALCIUM (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	542725
Ukraine	67748	АКТИВНЫЙ ИНГРЕДИЕНТ ДЛЯ ПРОИЗВОДСТВА ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ИНГИБИРОВАНИЯ РЕЗОРБЦИИ КОСТНОЙ ТКАНИ У ЧЕЛОВЕКА (ВАРИАНТЫ);АКТИВНИЙ ІНГРЕДІЄНТ ДЛЯ ВИРОБНИЦТВА ЛІКАРСЬКОГО ЗАСОБУ ДЛЯ ІНГІБУВАННЯ РЕЗОРБЦІЇ КІСТКОВОЇ ТКАНИНИ У ЛЮДИНИ (ВАРІАНТИ) (ACTIVE INGREDIENT FOR PHARMACEUTICAL COMPOSITIONS INTENDED FOR INHIBITING BONE RESORPTION (VARIANTS))
Canada	2349733
Croatia	P20000035
Norway	941894
Spain	2149781

Supplementary Protection Certificates for ACTONEL WITH CALCIUM (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0998292	PA2006002	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
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
2957286	1990003-4	Sweden		PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
0186405	SPC/GB00/021	United Kingdom		PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
2957286	300962	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
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

Market Dynamics and Financial Trajectory for ACTONEL WITH CALCIUM (COPACKAGED)

Last updated: August 29, 2025

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Introduction

Actonel with Calcium (copackaged) represents a combination therapy designed to manage osteoporosis by simultaneously providing a bisphosphonate (risedronate) alongside calcium supplementation. This strategic formulation aims to enhance patient adherence, optimize bone health, and streamline osteoporosis management. Over recent years, the osteoporosis therapeutics market has experienced significant shifts driven by demographic trends, regulatory landscapes, and evolving healthcare policies. This analysis delves into the intricate market dynamics shaping the trajectory of Actonel with Calcium copackaged formulations and forecasts its financial performance within the global pharmaceutical landscape.

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Market Overview and Segmentation

Product Profile

Actonel with Calcium copackage pairs risedronate sodium, a potent bisphosphonate, with calcium carbonate, facilitating concurrent osteoporosis treatment and nutritional support. Such combination products target postmenopausal women, osteoporosis patients with calcium deficiency, and elderly populations prone to fractures.

Market Segmentation

• Geography: North America (United States, Canada), Europe (Germany, UK, France), Asia-Pacific (Japan, China, India), and emerging markets.
• Patient Demographics: Postmenopausal women, elderly individuals, patients with glucocorticoid-induced osteoporosis.
• Distribution Channels: Hospitals, specialty clinics, community pharmacies, online pharmacies.

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Market Dynamics Influencing the Trajectory

Demographic and Epidemiological Drivers

The rising global incidence of osteoporosis, particularly among aging populations, is the primary growth driver. The World Health Organization (WHO) estimates over 200 million women worldwide suffer from osteoporosis, with a 1 in 3 women over 50 expected to experience osteoporotic fractures (WHO, 2021). Developed nations witness an increasing shift towards medication adherence strategies, favoring copackaged formulations like Actonel with Calcium.

Regulatory Environment

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have stringent approval pathways for combination therapies, often emphasizing safety and efficacy data. Recent approvals of bisphosphonates and calcium supplements have bolstered confidence in copackaged formulations, although concerns about potential gastrointestinal side effects of bisphosphonates prompt rigorous post-marketing surveillance.

Healthcare Policy and Reimbursement Trends

Insurance companies and national health services increasingly favor combination products for their cost-effectiveness and improved adherence outcomes. Reimbursement policies favor medications that reduce fracture-related hospitalizations, making Actonel with Calcium more attractive within formulary decisions.

Competitive Landscape

The osteoporosis medication market features key players like Novartis, Merck, and Teva, offering various bisphosphonates and calcium supplements. Copackaged products face competitive pressure from monotherapies, but their integrated delivery offers a distinct patient advantage, supporting sustained market share.

Technological and Formulation Advances

Innovations in drug delivery systems, such as modified release formulations and effervescent calcium, have improved tolerability and absorption, enhancing the appeal of combination products. The shift toward patient-centric formulations underpins market growth.

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Financial Trajectory and Market Forecast

Current Market Valuation

The global osteoporosis drugs market was valued at approximately USD 12 billion in 2022, with bisphosphonates accounting for a significant share. The segment of combination formulations like Actonel with Calcium is experiencing accelerated growth due to increasing awareness and compliance.

Projected Market Growth

Analysts forecast a Compound Annual Growth Rate (CAGR) of around 6-8% from 2023 through 2030 for osteoporosis therapies, with copackaged formulations growing at a slightly higher rate due to their convenience and adherence benefits (Grand View Research, 2023).

Financial Outlook

• Revenue Streams: Sales generated by prescription volumes, therapeutic adherence programs, and regional market penetration.
• Geographical Expansion: Emerging markets, notably Asia-Pacific, are expected to contribute approximately 35% of incremental revenue growth owing to expanding healthcare access and aging populations.
• Pricing Strategies: Premium pricing persists in mature markets due to brand recognition, with price pressures in price-sensitive regions prompting tiered offerings or generic entry.

Key Market Influencers

• Patient adherence improvements are projected to boost sales, with copackaged products demonstrating 20-30% higher compliance rates compared to monotherapies (Pharma Intelligence, 2022).
• Regulatory approvals of new formulations and indications could further widen market access.
• Potential patent expirations and the transition to generic alternatives pose risks but may also catalyze volume-led growth in cost-competitive markets.

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Challenges and Opportunities

Challenges

• Side effect profiles, notably osteonecrosis of the jaw and atypical femoral fractures, necessitate vigilant post-market monitoring.
• Competition from alternative bisphosphonates, denosumab, and emerging anabolic agents like teriparatide.

Opportunities

• Strategic collaborations to expand formulations, such as injectable or patch-based delivery systems.
• Increasing focus on personalized medicine, enabling tailored osteoporosis therapies.
• Integration into broader bone health management programs aligned with aging populations.

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Conclusion

The market dynamics for Actonel with Calcium copackaged demonstrate a robust growth trajectory driven by demographic shifts, regulatory favorable environments, and technological innovations. Its financial prospects hinge on continuous clinical evidence to support adherence benefits, strategic regional expansion, and competitive positioning. As healthcare systems pivot toward integrated, patient-centric approaches, copackaged osteoporosis treatments are poised to sustain their market foothold and contribute meaningfully to global bone health management.

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Key Takeaways

• The aging global population and rising osteoporosis prevalence are primary growth drivers for copackaged therapies like Actonel with Calcium.
• Regulatory and reimbursement landscapes favor combination products that enhance compliance and reduce healthcare costs.
• Market forecasts suggest a high single-digit CAGR, with emerging markets contributing significantly to revenue expansion.
• Innovations in drug formulation and delivery systems will further catalyze market growth.
• Competitive pressures necessitate strategic differentiation, particularly around safety profiles and patient adherence.

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FAQs

1. What positioning does Actonel with Calcium have compared to other osteoporosis treatments?
   It offers combined bisphosphonate therapy with calcium, enhancing compliance and simplifying treatment regimens compared to separate administration of individual agents.

2. What are the main factors influencing its adoption in emerging markets?
   Growing osteoporosis awareness, rising healthcare infrastructure, and increasing affordability contribute to its expanding presence in emerging economies.

3. Are there safety concerns associated with copackaged Actonel with Calcium?
   Similar to other bisphosphonates, risks include gastrointestinal irritation and rare adverse effects like osteonecrosis of the jaw. Proper patient selection and monitoring mitigate these risks.

4. How does innovation impact the market trajectory of such combination drugs?
   Advances in delivery systems and formulations improve tolerability, compliance, and efficacy, thereby strengthening market positioning and financial outlooks.

5. What strategic moves can pharmaceutical companies pursue to maximize profits from Actonel with Calcium?
   Developing new formulations, expanding into underserved markets, engaging in collaborations, and conducting post-market safety studies are key strategies.

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Sources
[1] World Health Organization (2021). Global osteoporosis report.
[2] Grand View Research (2023). Osteoporosis Drugs Market Size & Trends.
[3] Pharma Intelligence (2022). Patient adherence in osteoporosis therapy.