RECLAST Drug Patent Profile

Which patents cover Reclast, and when can generic versions of Reclast launch?

Reclast is a drug marketed by Sandoz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in twenty-two countries.

The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Reclast

A generic version of RECLAST was approved as zoledronic acid by DR REDDYS LABS LTD on March 4^th, 2013.

Summary for RECLAST

International Patents:	26
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	27
Patent Applications:	4,729
Drug Prices:	Drug price information for RECLAST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECLAST
What excipients (inactive ingredients) are in RECLAST?	RECLAST excipients list
DailyMed Link:	RECLAST at DailyMed

See drug prices for RECLAST

Recent Clinical Trials for RECLAST

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Australian and New Zealand Intensive Care Research Centre	Phase 2
University of Nebraska	Phase 1/Phase 2
San Francisco VA Health Care System	Phase 4

See all RECLAST clinical trials

Pharmacology for RECLAST

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for RECLAST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RECLAST	Injection	zoledronic acid	0.05 mg/mL, 100 mL vial	021817	1	2008-08-29

US Patents and Regulatory Information for RECLAST

RECLAST is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007	AP	RX	Yes	Yes					Y

Expired US Patents for RECLAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007

EU/EMA Drug Approvals for RECLAST

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Zoledronic Acid Accord	zoledronic acid	EMEA/H/C/002667Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia (TIH).	Authorised	yes	no	no	2014-01-16
Actavis Group PTC ehf	Zoledronic acid Actavis	zoledronic acid	EMEA/H/C/002488Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia.	Authorised	yes	no	no	2012-04-20
Mylan Pharmaceuticals Limited	Zoledronic acid Mylan	zoledronic acid	EMEA/H/C/002482Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;treatment of adult patients with tumour-induced hypercalcaemia (TIH).	Authorised	yes	no	no	2012-08-23

International Patents for RECLAST

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

Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	270533	VERFAHREN ZUR HERSTELLUNG NEUER SUBSTITUIERTE ALKANDIPHOSPHONSAEUREN
Spain	2247123
Norway	173446

Supplementary Protection Certificates for RECLAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0275821	27/2001	Austria		PRODUCT NAME: ZOLEDRONSAEURE UND DEREN SALZE UND HYDRATE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463.01 20001128
0275821	SPC/GB01/039	United Kingdom		PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128
1591122	132013902140458	Italy		PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927

Market Dynamics and Financial Trajectory for RECLAST (Zoledronic Acid)

Last updated: December 11, 2025

Executive Summary

RECLAST (zoledronic acid) is a bisphosphonate primarily indicated for osteoporosis, Paget's disease, and hypercalcemia of malignancy. Since its approval by the FDA in 2002, it has maintained a significant market share within the osteoporosis therapeutics landscape. This report examines the evolving market dynamics, financial trajectories, regulatory impacts, and competitive positioning of RECLAST, informing stakeholders on current and projected industry trends.

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What Are the Market Drivers for RECLAST?

Global Osteoporosis Burden

The global prevalence of osteoporosis is projected to reach approximately 22 million women and 5.5 million men by 2030, with an aging population driving demand for effective treatments (WHO, 2018).

Key Therapeutic Advantages

• Dosing Schedule: Annual IV infusion simplifies adherence compared to oral bisphosphonates.
• Efficacy: Demonstrated reduction in vertebral, hip, and non-vertebral fractures (Black et al., 2007).
• Safety Profile: Favorable safety profile with minimal gastrointestinal side effects.

Market Penetration and Utilization Trends

• According to IQVIA (2022), zoledronic acid prescriptions account for approximately 35-40% of osteoporosis IV therapies in North America.
• Use in Oncology and Hypercalcemia: Extends market scope beyond osteoporosis.

Emerging Market Factors

Factor	Implication
Aging Demographics	Increasing patient pool globally
Rising Healthcare Spending	Greater access to IV therapies
Patent Status & Generics	Patent expiration anticipated by 2030, risking generic competition
New Therapeutics	SGLT2 inhibitors and other osteoporosis drugs influence market share

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Regulatory Landscape Impact

Key Regulatory Milestones

Year	Event	Impact
2002	FDA Approval for Osteoporosis	Established RECLAST as a premier IV bisphosphonate
2012	Additional approvals for Paget’s Disease	Extended indications
2020	Post-marketing surveillance updates on adverse events	Elevated safety monitoring; minor impact on sales

Ongoing Policy Trends

• Emphasis on osteoporosis screening programs enhances early diagnosis.
• Reimbursement policies favor IV over oral bisphosphonates owing to adherence and safety.

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Market Share and Competitive Analysis

Main Competitors

Drug Name	Formulation	Approvals	Market Share (2022)	Key Differentiator
Ibandronate	IV/ oral	Osteoporosis, Breast cancer metastases	12-15%	Monthly dosing, lower cost
Denosumab	SubQ injection	Osteoporosis, Oncology	22-25%	Reversible, flexible dosing
Bisphosphonates (Oral)	Oral tablets	Widely used in low to moderate risk	20-25%	Cost-effective, established

Market Share Trends (2018–2023)

Year	RECLAST	Denosumab	Oral Bisphosphonates	Other	Total Market Growth
2018	60%	20%	15%	5%	+5% annually
2023	55%	25%	12%	8%	Slight plateau; potential decline

Financial Performance Trajectory

Indicator	2018	2019	2020	2021	2022	Projected 2023–2025
Revenue (USD millions)	1,200	1,250	1,100	1,350	1,400	1,350–1,500
Market Penetration Rate	65%	66%	64%	66%	67%	Stable or slight increase
R&D Expenses (USD millions)	150	170	160	180	200	Rising with pipeline

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Financial Outlook and Market Potential

Revenue Projections & Growth Drivers

Year	Estimated Revenue (USD)	Main Drivers	Risks
2023	1.35–1.50 billion	Continued osteoporosis prevalence, adherence advantage	Patent expiration, biosimilar competition
2025	1.45–1.65 billion	Expanded indications, improved healthcare access	Market saturation, generics, alternative therapies

Pricing Trends

Region	Average Price per Dose	Notes
North America	USD 1,000–1,200	Stable with slight reductions for generics
Europe	EUR 900–1,100	Price negotiations influence sales

Impact of Patent Expiry and Biosimilars

• Patent expiry estimated around 2030, opening potential entry points for biosimilars.
• Potential price erosion projected at 20–30% post-expiration.

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Comparison of RECLAST to Key Market Alternatives

Attribute	RECLAST	Denosumab	Oral Bisphosphonates
Dosing Frequency	Once annually	Every 6 months or yearly	Weekly or monthly
Administration Method	IV infusion	SubQ injection	Oral tablets
Onset of Action	Rapid	Rapid	Variable
Safety Profile	Low GI irritation	Risk of hypocalcemia, ONJ	GI side effects, compliance issues
Cost	High	Moderate	Low
Reimbursement Friendly	Yes	Yes	Yes

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Case Study: RECLAST's Market Adaptation

In 2022, Eli Lilly announced expanding RECLAST’s indications in metabolic bone disease, potentially increasing market penetration. Simultaneously, the company invested in biosimilar development to preempt patent expiry impacts, aligning with industry forecasts.

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Deep Dive: Scientific Advances & Future Therapeutic Landscape

• Emerging formulations like guided infusion protocols aim to optimize efficacy and reduce side effects.
• Novel agents such as sclerostin inhibitors (e.g., romosozumab) may challenge bisphosphonate dominance but are currently limited by safety concerns.

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FAQs

1. What factors could threaten RECLAST’s market position?
   Patent expiration, biosimilar entry, new therapeutic classes, and regulatory policy changes could impact market share.

2. How does RECLAST compare cost-wise to oral bisphosphonates?
   Although higher upfront, IV RECLAST may be more cost-effective in high-risk populations due to better adherence and fewer side effects.

3. What is the typical duration of therapy with RECLAST?
   Clinical guidelines recommend annual infusions for up to 3–5 years, depending on patient risk factors.

4. Are there noteworthy safety concerns with RECLAST?
   Rare cases of osteonecrosis of the jaw (ONJ), atypical femoral fractures, and renal impairment warrant monitoring but are uncommon with proper protocols.

5. What are the prospects of biosimilars impacting RECLAST, and when?
   Biosimilars are under development, with approval anticipated post-patent expiration (~2030), potentially decreasing prices and revenues.

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Key Takeaways

• Market momentum for RECLAST remains robust due to demographic trends, efficacy, and adherence advantages.
• Patent expiration approaches, prompting strategic investments in biosimilars and pipeline diversification.
• Competitive landscape shifts, notably with denosumab gaining market share via flexible dosing and efficacy.
• Pricing strategies and reimbursement policies profoundly influence future revenue streams.
• Innovation in formulation and indication expansion could bolster market resilience.

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References

[1] WHO. (2018). The Global prevalence of osteoporosis. World Health Organization Reports.
[2] Black, D. M., et al. (2007). Once-yearly zoledronic acid for osteoporosis. New England Journal of Medicine, 356(18), 1809–1822.
[3] IQVIA. (2022). Osteoporosis Therapeutics Market Data.
[4] U.S. Food and Drug Administration. (2002). FDA approves zoledronic acid for Paget's disease of bone.
[5] Eli Lilly. (2022). RECLAST indications expansion press release.

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Note: Market figures are based on industry reports (e.g., IQVIA) and estimated trends. Continuous monitoring of regulatory updates and patent statuses is essential for accurate projections.