ZOLEDRONIC Drug Patent Profile

Which patents cover Zoledronic, and what generic alternatives are available?

Zoledronic is a drug marketed by Gland Pharma Ltd, 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, Gland, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, and USV. and is included in thirty-eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zoledronic

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

Summary for ZOLEDRONIC

US Patents:	0
Applicants:	26
NDAs:	38
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	232
Clinical Trials:	290
Patent Applications:	71
Drug Prices:	Drug price information for ZOLEDRONIC
DailyMed Link:	ZOLEDRONIC at DailyMed

See drug prices for ZOLEDRONIC

Recent Clinical Trials for ZOLEDRONIC

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

Sponsor	Phase
Lund University Hospital	Phase 4
Aksaray University	Phase 4
Sun Yat-sen University	Phase 3

See all ZOLEDRONIC clinical trials

Pharmacology for ZOLEDRONIC

Drug Class

Bisphosphonate

US Patents and Regulatory Information for ZOLEDRONIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sagent Pharms Inc	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	091493-001	Nov 24, 2014	AP	RX	No	No
Mylan Labs Ltd	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	202650-001	Mar 4, 2013	AP	RX	No	No
Gland Pharma Ltd	ZOLEDRONIC	zoledronic acid	INJECTABLE;INTRAVENOUS	205749-001	Jun 29, 2018	AP	RX	No	Yes
Novast Labs	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	208968-001	Feb 19, 2020		DISCN	No	No
Eugia Pharma	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	209125-001	Dec 8, 2017		DISCN	No	No
Meitheal	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	213371-001	Jun 5, 2023	AP	RX	No	No

EU/EMA Drug Approvals for ZOLEDRONIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sandoz Pharmaceuticals d.d.	Aclasta	zoledronic acid	EMEA/H/C/000595 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 and in men at increased risk of fracture., , Treatment of Paget's disease of the bone.,	Authorised	no	no	no	2005-04-15
Pfizer Europe MA EEIG	Zoledronic Acid Hospira	zoledronic acid	EMEA/H/C/002365 4 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/002439 Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.	Authorised	yes	no	no	2012-08-16
Mylan Pharmaceuticals Limited	Zoledronic acid Mylan	zoledronic acid	EMEA/H/C/002482 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).	Authorised	yes	no	no	2012-08-23
Actavis Group PTC ehf	Zoledronic acid Actavis	zoledronic acid	EMEA/H/C/002488 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.	Authorised	yes	no	no	2012-04-20
Accord Healthcare S.L.U.	Zoledronic Acid Accord	zoledronic acid	EMEA/H/C/002667 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).	Authorised	yes	no	no	2014-01-16

Zoledronic Acid Market Dynamics and Financial Trajectory

Market Overview

Zoledronic acid, commonly known by the brand name Reclast, is a bisphosphonate drug used to treat various bone-related conditions, including osteoporosis, bone metastases, and Paget’s disease. The market for zoledronic acid is poised for significant growth, driven by several key factors.

Market Size and Growth

The zoledronic acid market is estimated to reach $2.83 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of 5.1% from 2022 to 2027[1][3][4].

Geographical Distribution

Geographically, North America dominates the zoledronic acid market due to its robust medical infrastructure and high healthcare expenditure. However, the Asia-Pacific region is expected to offer lucrative growth opportunities, driven by the rising prevalence of bone-related diseases and improving healthcare infrastructure[1][3].

Market Segmentation

By Application

The zoledronic acid market is segmented into several applications, including:

• Osteoporosis: This segment held a dominant market share in 2021 and is expected to be the fastest-growing segment with a CAGR of 5.8% from 2022 to 2027. Osteoporosis is highly prevalent in post-menopausal women and patients on glucocorticoids[1].
• Metastatic Bone Cancers: Zoledronic acid is also used to treat bone metastases, which is a significant market driver.
• Systemic Metabolic Bone Diseases: This includes conditions like Paget’s disease.
• Others: Other bone-related diseases also contribute to the market demand[1].

By Distribution Channel

The market is segmented into offline and online distribution channels. The offline mode, which includes pharmacy stores and medical stores, held a dominant market share in 2021. However, the online channel is emerging as a fast-growing segment due to increasing consumer preference for online shopping and the convenience it offers[1][4].

Market Drivers

Several factors are driving the growth of the zoledronic acid market:

• Increasing Prevalence of Bone-Related Diseases: The rising incidence of osteoporosis and bone metastases, particularly in the aging population, is a major driver. Approximately 200 million people suffer from osteoporosis globally, with nearly one in every three women experiencing osteoporotic fractures[1][3].
• Growing Awareness About Bone Health: Governments and healthcare organizations are increasing awareness about bone health, leading to higher demand for medications like zoledronic acid[3].
• Advancements in Medical Research and Technology: Continuous research and technological advancements in the field of bone health are fueling market growth[3].

Market Restraints

Despite the growth drivers, the market faces several challenges:

• Stringent Regulations: Complex regulatory requirements pose a significant hurdle for market growth.
• Adverse Side Effects: Zoledronic acid can cause side effects such as hypocalcemia (low calcium levels) and kidney issues, which can halt market growth. It is contraindicated in patients with severe kidney diseases and low calcium levels[1][2].
• Availability of Alternatives: The presence of alternative drug classes and the entry of generic competition can reduce the market share of branded zoledronic acid products[1][2].

Financial Trajectory

Cost Analysis

The total annual costs for zoledronic acid, including drug and administration costs, are significant. For instance, the average nondrug administration cost for zoledronic acid is $187 per infusion, with an average paid drug cost of $1269, resulting in a total annual cost of $1456. This is higher than previous analyses based on modeled resource use[2].

Generic Competition

The approval of generic versions of zoledronic acid is expected to increase market competition and drive down costs for patients. However, the paid drug costs have generally reflected values at or above the branded Wholesale Acquisition Cost (WAC) price, suggesting a lag in adjustments to reimbursement or continued high uptake of branded products[2].

Revenue Generation

The market presents lucrative opportunities for pharmaceutical companies through the development and sale of zoledronic acid products. The revenue generation is expected to be substantial, given the growing demand and the long-lasting effects of the drug, which enhance patient convenience and compliance[3].

Competitive Landscape

The zoledronic acid market is characterized by the presence of several key players offering innovative products and treatment solutions. Strategic collaborations and partnerships between pharmaceutical companies are common, aimed at enhancing product offerings and expanding market reach. Technological advancements and research in new applications beyond osteoporosis and bone metastases are also driving market dynamics[3].

SWOT Analysis

Strengths

• Long-Lasting Effects: Zoledronic acid offers long-lasting effects, reducing the frequency of dosing.
• High Efficacy: It is highly effective in treating bone-related conditions.
• Established Market Presence: The drug has a well-established market presence[3].

Weaknesses

• High Cost of Treatment: The treatment is costly, which can be a barrier for some patients.
• Complex Regulatory Requirements: Stringent regulations can slow down market growth[3].

Opportunities

• New Applications: Exploring new applications beyond osteoporosis and bone metastases.
• Personalized Medicine: Leveraging personalized medicine and targeted therapies[3].

Threats

• Competition from Alternatives: Competition from other treatment options.
• Potential Side Effects: Adverse side effects associated with the drug[3].

Key Industry Developments

• Approval of Generic Versions: Regulatory approvals for generic versions of zoledronic acid are increasing market competition.
• Research and Clinical Trials: Ongoing research is focused on exploring new applications and improving treatment outcomes.
• Product Portfolio Expansion: Market players are expanding their product portfolios with new formulations and delivery systems[3].

Analyst Suggestions

Analysts suggest that industry participants should focus on strategic collaborations, product innovation, and expanding market reach. Monitoring and adapting to market dynamics, such as demographic changes and healthcare policies, is also crucial for staying competitive[3].

Key Takeaways

• The zoledronic acid market is expected to grow significantly, driven by the increasing prevalence of bone-related diseases and growing awareness about bone health.
• North America dominates the market, but the Asia-Pacific region is expected to offer lucrative growth opportunities.
• The osteoporosis segment is the fastest-growing segment, driven by its high prevalence in post-menopausal women and patients on glucocorticoids.
• The market faces challenges such as stringent regulations, adverse side effects, and the availability of alternatives.
• Generic competition is expected to drive down costs, but the high cost of treatment remains a barrier.

FAQs

Q: What is the projected market size of zoledronic acid by 2027? A: The zoledronic acid market is estimated to reach $2.83 billion by 2027[1].

Q: What is the primary application of zoledronic acid? A: The primary application of zoledronic acid is in the treatment of osteoporosis, followed by metastatic bone cancers and other bone-related diseases[1].

Q: Which region dominates the zoledronic acid market? A: North America dominates the zoledronic acid market due to its robust medical infrastructure and high healthcare expenditure[1][3].

Q: What are the major challenges facing the zoledronic acid market? A: The major challenges include stringent regulations, adverse side effects, and the availability of alternative drug classes[1][2].

Q: How is the entry of generic versions affecting the zoledronic acid market? A: The entry of generic versions is expected to increase market competition and drive down costs for patients, although the paid drug costs have generally reflected values at or above the branded WAC price[2].

Cited Sources:

1. IndustryARC - Zoledronic Acid Market - Forecast(2024 - 2030)[1]
2. Pharmacy Times - Administration Costs of Denosumab and Zoledronic Acid for Postmenopausal Osteoporosis[2]
3. MarkWide Research - Zoledronic Acid Market 2024-2032 | Size, Share, Growth[3]
4. Cognitive Market Research - Bisphosphonate Drug Market Report 2024 (Global Edition)[4]