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	6,165,513*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	6,465,443*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	6,015,801*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
South Africa	9805010
Poland	338635
China	1274279
European Patent Office	0989848	COMPRIME A ENROBAGE PELLICULAIRE A INNOCUITE ACCRUE A L'EGARD DU TRACTUS OESO-GASTRO-DUODENAL (FILM-COATED TABLET FOR IMPROVED UPPER GASTROINTESTINAL TRACT SAFETY)
Spain	557322
Israel	133405	צורת מינון פומית למתן לקיבה (Oral dosage form to be delivered to the stomach)

Supplementary Protection Certificates for ACTONEL WITH CALCIUM (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0186405	2000C/028	Belgium		PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
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
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721

ACTONEL WITH CALCIUM (COPACKAGED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Actonel with Calcium (Copackaged)

Introduction

Actonel with Calcium, a copackaged product combining risedronate sodium tablets with calcium carbonate tablets, is a significant player in the osteoporosis treatment market. This article delves into the market dynamics and financial trajectory of this drug, highlighting its approval, usage, side effects, pricing trends, and market impact.

Approval and Indications

Actonel with Calcium was approved by the U.S. Food and Drug Administration (FDA) in August 2005 for the prevention and treatment of postmenopausal osteoporosis. This approval marked a significant milestone as it was the first prescription osteoporosis therapy to include calcium in a single package[1].

Market Need and Target Audience

Osteoporosis is a widespread and growing public health threat, particularly among postmenopausal women. The inclusion of calcium in Actonel with Calcium addresses a critical component of osteoporosis therapy, simplifying the treatment regimen for patients[1].

Clinical Efficacy

Clinical trials have shown that Actonel with Calcium is effective in reducing the incidence of vertebral and nonvertebral fractures. For instance, Actonel 5 mg daily significantly reduced the incidence of new and worsening vertebral fractures and nonvertebral osteoporosis-related fractures over a three-year period[4].

Side Effects and Tolerability

Actonel with Calcium has been generally well tolerated in clinical trials. Common side effects include infections, back pain, arthralgia, and muscle pain. However, these side effects are comparable to those seen in placebo groups, indicating a favorable safety profile[1][2].

Pricing Trends

The pricing of osteoporosis drugs, including Actonel with Calcium, has been a subject of interest due to its impact on patient access and healthcare costs. Studies have shown that the prices of osteoporosis drugs have increased faster than inflation between 1988 and 2014. However, the entry of generic drugs into the market has significantly driven down prices, although branded drugs continue to see price increases even after generic competition[3].

Market Competition

The osteoporosis drug market is competitive, with several other bisphosphonates and alternative treatments available. Actonel with Calcium competes with other branded and generic osteoporosis medications. The convenience of having both the bisphosphonate and calcium in one package is a unique selling point, but it must contend with other treatments that may offer similar benefits at lower costs[3].

Financial Impact

The financial trajectory of Actonel with Calcium is influenced by several factors, including market competition, pricing strategies, and regulatory environments. The drug's approval and subsequent marketing have contributed to the revenue streams of its manufacturers, Procter & Gamble and Sanofi Aventis. However, the increasing competition from generic drugs and other osteoporosis treatments has likely impacted the drug's market share and revenue over time[1].

Reimbursement and Access

The reimbursement rates for Actonel with Calcium vary significantly depending on the payer and the market. For instance, Medicare Part B and the Federal Supply Schedule (FSS) have lower reimbursement rates compared to the average wholesale price (AWP) of the drug. This disparity affects the drug's accessibility and the financial burden on patients and healthcare systems[3].

Regulatory Considerations

Regulatory approvals and compliance are crucial for the continued market presence of Actonel with Calcium. The FDA's approval process and subsequent updates, such as label changes and safety monitoring, play a significant role in the drug's market dynamics. Compliance with regulatory requirements helps maintain the drug's credibility and market position[4].

Consumer and Healthcare Provider Perspectives

From a consumer perspective, Actonel with Calcium offers a convenient and simplified treatment regimen, which is particularly beneficial for patients managing chronic conditions like osteoporosis. Healthcare providers appreciate the drug's efficacy and the ease of prescribing a single package that includes both the bisphosphonate and calcium, enhancing patient compliance[1].

Future Outlook

The future outlook for Actonel with Calcium is shaped by ongoing market trends, including the rise of generic competition and the development of new osteoporosis treatments. While the drug remains a viable option for many patients, its market share and financial performance will likely be influenced by these external factors. Innovations in packaging and dosing regimens, as well as strategic pricing, will be key to maintaining its competitive edge[3].

Key Takeaways

• Approval and Indications: Actonel with Calcium was approved by the FDA in 2005 for postmenopausal osteoporosis treatment.
• Clinical Efficacy: The drug is effective in reducing vertebral and nonvertebral fractures.
• Pricing Trends: Prices have increased faster than inflation, but generic competition has driven down costs.
• Market Competition: The drug competes with other bisphosphonates and alternative treatments.
• Financial Impact: Revenue is influenced by market competition, pricing strategies, and regulatory environments.
• Reimbursement and Access: Reimbursement rates vary, affecting accessibility and financial burden.
• Regulatory Considerations: Compliance with FDA regulations is crucial for market presence.
• Consumer and Healthcare Provider Perspectives: The drug offers a convenient treatment regimen, enhancing patient compliance.

FAQs

What is Actonel with Calcium used for?

Actonel with Calcium is used for the prevention and treatment of postmenopausal osteoporosis.

How does Actonel with Calcium work?

Actonel with Calcium works by inhibiting osteoclast-mediated bone resorption and modulating bone metabolism, while the included calcium supports bone health.

What are the common side effects of Actonel with Calcium?

Common side effects include infections, back pain, arthralgia, and muscle pain, which are generally comparable to those seen in placebo groups.

How does the pricing of Actonel with Calcium compare to other osteoporosis drugs?

The prices of Actonel with Calcium have increased faster than inflation, but the entry of generic drugs has significantly reduced costs.

What is the impact of generic competition on Actonel with Calcium?

Generic competition has driven down the prices of Actonel with Calcium, although branded versions continue to see price increases.

Sources

1. P&G, Sanofi Aventis: The U.S. Food And Drug Administration Approves Actonel R With Calcium. Biospace.
2. Actonel: Side effects, dosage, alternatives, uses, and more. Medical News Today.
3. OSTEOPOROSIS DRUGS MARKETED IN THE UNITED STATES. PubMed.
4. ACTONEL® with CALCIUM (risedronate sodium tablets with calcium carbonate tablets, USP). FDA.
5. Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP). FDA.