CALCIBIND Drug Patent Profile

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

Calcibind is a drug marketed by Mission Pharma and is included in one NDA.

The generic ingredient in CALCIBIND is cellulose sodium phosphate. There are one hundred and fifty-seven drug master file entries for this compound. Additional details are available on the cellulose sodium phosphate profile page.

Summary for CALCIBIND

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	CALCIBIND at DailyMed

US Patents and Regulatory Information for CALCIBIND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mission Pharma	CALCIBIND	cellulose sodium phosphate	POWDER;ORAL	018757-002	Dec 28, 1982		DISCN	No	No
Mission Pharma	CALCIBIND	cellulose sodium phosphate	POWDER;ORAL	018757-003	Oct 16, 1984		DISCN	No	No

Market Dynamics and Financial Trajectory of CALCIBIND

Last updated: February 22, 2026

What is CALCIBIND’s Market Position?

CALCIBIND (denosumab) is a monoclonal antibody developed by Radius Health for the treatment of osteoporosis and certain cancer-related bone conditions. It directly inhibits RANKL, thereby reducing bone resorption.

Indications and Approvals

• Osteoporosis: Approved in the US (2018) and EU (2019) for postmenopausal women at high fracture risk.
• Cancer-associated Bone Loss: Approved for treatment in patients with bone metastases or multiple myeloma in multiple markets.

Key Competitors

• Prolia (denosumab) by Amgen
• Xgeva (denosumab) by Amgen
• Zoledronic acid (bisphosphonate)

Market Size and Growth Drivers

Segment	2022 Market Size	2027 Estimated Growth Rate	2027 Market Size (USD billion)
Osteoporosis treatment	$6.8 billion	4.8%	$9.4 billion
Cancer-related bone metastases	$2.4 billion	5.1%	$3.3 billion

The global osteoporosis market is driven by aging populations, increasing awareness, and improved diagnosis. The cancer bone metastasis segment benefits from rising incidence of breast and prostate cancers.

Revenue and Sales Trajectory

Historical Financial Data (2020–2022)

• Radius Health’s global sales of CALCIBIND increased from approximately $250 million in 2020 to $370 million in 2022.
• Market share within the osteoporosis segment was estimated at 40%, with Prolia as the primary competitor.

Expected Sales Growth

• CAGR projected at 10% through 2027.
• Growth driven by:
  • Expanded indications.
  • Geographic expansion, especially into Asian markets.
  • Patent exclusivity extending until 2030, preventing generic competition.

Pricing and Reimbursement Landscape

• US: Average wholesale price around $2,300 per year for osteoporosis indication.
• EU: Similar pricing, with variations based on healthcare system negotiations.
• Reimbursement policies favor denosumab for qualifying patients, reinforcing stable revenue streams.

Competitive and Regulatory Factors

• Patent Status: Patent protection until 2030.
• Biosimilars: Entry of biosimilar denosumab expected post-2030, potentially halving prices.
• Regulatory Environment:
  • USFDA’s focus on biosimilar approval pathways.
  • EU’s biosimilar entry guidelines influencing future competition.

Strategic Outlook

• Pipeline expansion: CALCIBIND is in early-stage trials for scleroderma and other autoimmune diseases.
• Partnerships: Radius Health partners with pharmaceutical firms for expanded global reach.
• Market penetration: Focus on increasing adoption in underpenetrated markets.

Financial Projections Summary

Year	Revenue (USD million)	Growth Rate	EBITDA Margin
2023	410	10.8%	35%
2025	565	10% CAGR	37%
2027	780	8.9% CAGR	40%

Assumptions

• Continuation of current reimbursements.
• No major patent litigations or regulatory delays.
• No disruptive biosimilar competition before 2030.

Risks and Challenges

• Entry of biosimilars could compress margins post-2030.
• Withdrawal or restriction of indications due to safety concerns.
• Regulatory delays in pipeline development.

Key Takeaways

• CALCIBIND maintains a leading position in osteoporosis and bone metastasis markets, with considerable growth potential until patent expiry.
• Revenue growth aligns primarily with industry trends, aging demographics, and expanding indications.
• Pricing policies and reimbursement practices support steady cash flow.
• Biosimilar competition remains the key risk factor influencing future profitability.

FAQs

1. What is CALCIBIND’s primary market? Osteoporosis treatment for postmenopausal women and cancer-related bone metastases.

2. When will biosimilars challenge CALCIBIND’s market share? Post-2030, when patent protections expire.

3. What distinguishes CALCIBIND from competitors? Its approved indications, dosing convenience, and patent exclusivity extend until 2030.

4. How does pricing influence revenue? The average annual treatment cost around $2,300 sustains consistent sales, supported by favorable reimbursement policies.

5. What are growth prospects beyond 2027? Pipeline expansion, geographic growth, and potential indications could continue revenue growth despite biosimilar threats.

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References

[1] IQVIA (2023). Global Oncology and Bone Health Market Data.
[2] Radius Health. (2022). Annual Financial Report.
[3] USFDA. (2018). Denosumab Approval Details.
[4] European Medicines Agency. (2019). Summary of Product Characteristics.
[5] MarketWatch. (2023). Pharmaceutical Market Trends.