ZOLEDRONIC ACID - Generic Drug Details

What are the generic sources for zoledronic acid and what is the scope of freedom to operate?

Zoledronic acid is the generic ingredient in four branded drugs marketed by Sandoz, Gland, Accord Hlthcare, Actavis Inc, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, USV, and Novartis, and is included in forty NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zoledronic acid has thirty-nine patent family members in twenty-four countries.

There are twenty-five drug master file entries for zoledronic acid. Twenty-two suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for ZOLEDRONIC ACID

International Patents:	39
US Patents:	3
Tradenames:	4
Applicants:	27
NDAs:	40
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	301
Patent Applications:	5,661
Drug Prices:	Drug price trends for ZOLEDRONIC ACID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOLEDRONIC ACID
What excipients (inactive ingredients) are in ZOLEDRONIC ACID?	ZOLEDRONIC ACID excipients list
DailyMed Link:	ZOLEDRONIC ACID at DailyMed

See drug prices for ZOLEDRONIC ACID

Recent Clinical Trials for ZOLEDRONIC ACID

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

Sponsor	Phase
National Taiwan University Hospital, Yun-Lin Branch	PHASE4
National Taiwan University Hospital	PHASE4
University of Florida	PHASE1

See all ZOLEDRONIC ACID clinical trials

Generic filers with tentative approvals for ZOLEDRONIC ACID

Applicant	Application No.	Strength	Dosage Form
		4MG/5ML(0.8MG/ML)	INJECTABLE;INJECTION
		EQ 4MG BASE/5ML	INJECTABLE; IV (INFUSION)
		EQ 4MG BASE/VIAL	INJECTABLE; IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZOLEDRONIC ACID

Drug Class

Bisphosphonate

Anatomical Therapeutic Chemical (ATC) Classes for ZOLEDRONIC ACID

M05BA	Bisphosphonates
M05B	DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
M05	DRUGS FOR TREATMENT OF BONE DISEASES
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for ZOLEDRONIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOMETA	Injection	zoledronic acid	4 mg/100 mL, 100 mL vial	021223	1	2012-01-31
RECLAST	Injection	zoledronic acid	0.05 mg/mL, 100 mL vial	021817	1	2008-08-29
ZOMETA	Injection	zoledronic acid	0.8 mg (base) /mL	021223	1	2008-06-11

US Patents and Regulatory Information for ZOLEDRONIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	203841-001	Feb 14, 2017	AP	RX	No	No
Avet Lifesciences	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	201783-001	Mar 12, 2013	AP	RX	No	No
Fresenius Kabi Usa	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	091516-001	Apr 23, 2015	AP	RX	No	No
Dr Reddys	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	204344-001	Nov 19, 2018		DISCN	No	No
Usv	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	202923-001	Sep 4, 2014	AP	RX	No	No

Expired US Patents for ZOLEDRONIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003

EU/EMA Drug Approvals for ZOLEDRONIC ACID

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
Pfizer Europe MA EEIG	Zoledronic Acid Hospira	zoledronic acid	EMEA/H/C/0023654 mg / 5 ml and 4 mg / 100 ml:Prevention 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).5 mg / 100 ml:Treatment of osteoporosis:in post-menopausal women;in men;at increased risk of fracture, including those with a recent low-trauma hip fracture.Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:in post-menopausal women;in men;at increased risk of fracture.Treatment of Paget's disease of the bone in adults.	Authorised	yes	no	no	2012-11-19
Teva B.V.	Zoledronic acid Teva	zoledronic acid	EMEA/H/C/002439Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.	Authorised	yes	no	no	2012-08-16

International Patents for ZOLEDRONIC ACID

Country	Patent Number	Title	Estimated Expiration
Australia	6128301	Method of administering a bisphosphonate
China	1852739	Pharmaceutical products comprising bisphosphonates
New Zealand	545343	Pharmaceutical products comprising bisphosphonates
Japan	2007505861
Argentina	045670	PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS

Supplementary Protection Certificates for ZOLEDRONIC ACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0258618	SPC/GB01/042	United Kingdom		PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320
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
0275821	01C0035	France		PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128

Market Dynamics and Financial Trajectory for ZOLEDRONIC ACID

Last updated: January 21, 2026

Summary

Zoledronic acid is a potent bisphosphonate used primarily for managing osteoporosis, metastatic bone disease, and Paget’s disease. The global market for zoledronic acid is driven by rising osteoporosis prevalence, expanding oncology indications, and increasing awareness about bone health. Key players include Novartis and Teva, with the drug marketed under brand names such as Reclast and Zometa. The following analysis covers current market dynamics, revenue projections, competitive landscape, regulatory factors, and future growth trends, serving as an essential resource for stakeholders assessing investment opportunities or strategic positioning.

---

What Is Zoledronic Acid?

Zoledronic acid is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. It is administered intravenously, offering a convenient dosing schedule compared to oral options. Approved by FDA in 2001, it is used for various indications:

• Postmenopausal osteoporosis
• Hypercalcemia of malignancy
• Bone metastases in cancer (e.g., breast, prostate, multiple myeloma)
• Paget’s disease of bone

Active formulations include:	Brand Name	Manufacturer	Indications	Dosing Schedule
Zometa	Novartis	Cancer-related bone disease	4 mg IV every 3–4 weeks
Reclast	Novartis	Osteoporosis, Paget's	5 mg IV once yearly

---

Current Market Size and Revenue Trends

Global Market Valuation

The global zoledronic acid market was valued at approximately $1.8 billion in 2022 (with estimates varying $1.6–$2.0 billion). The compound annual growth rate (CAGR) forecasts an increase of 6–8% over the next five years, reaching roughly $3 billion by 2028.

Revenue Breakdown by Indication

Indication	Market Share (2022)	Growth Drivers	Key Players
Oncology-related bone metastases/Hypercalcemia	65%	Increasing cancer prevalence and supportive care expansion	Novartis (Zometa), Sanofi, Eisai
Osteoporosis	30%	Aging populations, osteoporosis awareness	Novartis (Reclast), Teva, Sandoz
Paget’s disease	5%	Rare disease, limited growth	Novartis, others

Note: Significant revenue derived from oncology indications—particularly in developed markets like North America and Western Europe.

Market Drivers

• Aging Population: The global geriatric demographic is expanding (~1 billion individuals over 65), increasing osteoporosis and metastasis-related cases.
• Cancer Incidence: An annual global cancer incidence exceeding 19 million (WHO, 2022) fuels demand for bisphosphonates.
• Healthcare Spending: Rising healthcare investments facilitate better diagnosis and treatment coverage for osteoporosis and cancer-related conditions.
• Treatment Guidelines: Adoption of zoledronic acid aligns with NCCN, ASCO, and ESMO guidelines, emphasizing IV bisphosphonates in treatment protocols.

---

Market Challenges

Factor	Implication	Mitigation Strategies
Generic Competition	Price erosion, reduced margins	Patent litigations, branding strategies
Safety Concerns	Osteonecrosis of the jaw, renal toxicity concerns	Improved patient monitoring, education
Alternative Treatments	Risedronate, denosumab, and newer agents	Differentiation through dosing convenience

---

Regulatory Framework and Patent Landscape

• Patent Expiry: Major patents expired in key jurisdictions (e.g., U.S. 2011, EU 2012). Generic versions entered markets subsequently.
• Regulatory Approvals: The drug is listed under numerous regulatory agencies; new indications or formulations require rigorous clinical trials.
• Pricing Policies: Governments and payers increasingly enforce cost-containment, affecting reimbursement and net prices.

---

Financial Trajectory and Strategic Outlook

Historical Revenue (Select Key Markets)

Region	2018	2019	2020	2021	2022 (Est.)
North America	$800M	$850M	$880M	$900M	$950M
Europe	$550M	$580M	$600M	$620M	$630M
Rest of World	$150M	$160M	$170M	$180M	$200M

Projected Revenue Growth (2023–2028)

Year	Projected Revenue (Billions USD)	Growth Rate (CAGR)
2023	$2.0	7%
2024	$2.15
2025	$2.31
2026	$2.48
2027	$2.66
2028	$2.86

Market Segmentation by Distribution Channel

Channel	Percentage Share (2022)	Remarks
Hospital Procurement	70%	Predominant in oncology settings
Specialty Clinics	20%	Osteoporosis management
Retail Pharmacy	10%	Limited, primarily for Paget’s

---

Competitive Landscape: Key Players and Market Share

Company	Product(s)	Estimated Market Share (2022)	Notable Strategies
Novartis	Zometa, Reclast	60%	Patent extensions, expansion of indications, global manufacturing
Teva	Generic zoledronic acid	20%	Price competitiveness, global supply chain
Sandoz	Generic formulations	10%	Cost leadership, targeted market penetration
Others	Various generics	10%	Focus on emerging markets, niche indications

---

Future Trends and Opportunities

Emerging Indications

• Osteonecrosis of the jaw (ONJ) management: Ongoing research aims to optimize dosing to reduce ONJ risk.
• Bisphosphonate formulations: Development of longer-acting formulations (e.g., subcutaneous implants) to improve adherence.
• Combination therapies: Combining zoledronic acid with other agents (e.g., denosumab) for synergistic effects.

Market Expansion Strategies

• Geographical expansion: Focused entry into emerging markets such as Asia-Pacific (estimated CAGR >10%).
• Digital health integration: Implementing patient monitoring apps to improve safety profiles.
• Partnerships: Strategic collaborations with biotech firms for novel formulations or indications.

---

Comparison With Similar Agents

Agent	Mechanism	Indications	Dosing Schedule	Market Share (2022)
Denosumab	RANKL inhibitor	Osteoporosis, bone metastases	60 mg SC every 6 months	25%
Ibandronate	Bisphosphonate	Postmenopausal osteoporosis	Monthly oral, quarterly IV	10%
Pamidronate	Bisphosphonate	Hypercalcemia	IV every 3–4 weeks	5%

Note: Zoledronic acid maintains a leading role in oncology indications because of its potency and dosing efficiency.

---

FAQs

1. What are the main drivers behind zoledronic acid’s market growth?
Demographic shifts (aging populations), rising cancer incidences, expanding indications, and evolving treatment guidelines primarily fuel growth.

2. How is generic competition impacting the market?
Post-patent expiration, generic versions have entered markets at lower prices, exerting downward pressure on revenues for brand-name products.

3. What safety concerns could influence the market?
Osteonecrosis of the jaw, renal toxicity, and atypical femoral fractures may limit use or prompt regulatory scrutiny, affecting market dynamics.

4. Are there any significant regulatory changes anticipated?
Regulatory agencies are increasingly emphasizing safety monitoring; new guidelines on risk management could influence prescribing patterns.

5. Which regions offer the most growth potential?
Emerging markets in Asia-Pacific are expected to exhibit the highest CAGR (>10%) driven by increasing healthcare access and awareness.

---

Key Takeaways

• Zoledronic acid stands as a leading bisphosphonate with a diversified portfolio spanning osteoporosis and oncology.
• The global market is projected to grow around 7% CAGR, driven by demographic trends and expanding indications.
• Generic competition is intensifying, necessitating innovative formulations and indication expansions to sustain revenue streams.
• Safety considerations and regulatory dynamics remain critical; companies investing in post-marketing safety and education retain competitive advantage.
• Emerging markets and digital health integrations present significant opportunities for growth and market penetration.

---

References

1. [World Health Organization (WHO), 2022] Global Cancer Statistics.
2. [MarketResearch.com, 2022] Bisphosphonates Market Report.
3. [FDA, 2001] Zoledronic Acid (Reclast) Approval Documentation.
4. [NCCN Guidelines, 2023] Osteoporosis Treatment Protocols.
5. [Novartis, 2022] Annual Report & Market Data.

Note: Exact figures and projections are based on publicly available reports and industry estimates as of 2023.