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 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, 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:	28
NDAs:	40
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	290
Patent Applications:	7,047
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
Lund University Hospital	Phase 4
Aksaray University	Phase 4
Sun Yat-sen University	Phase 3

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
Dr Reddys Labs Ltd	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	091363-001	Mar 29, 2013	AP	RX	No	No
Dr Reddys Labs Ltd	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	091186-001	Mar 4, 2013	AP	RX	No	Yes
Actavis Inc	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	202472-001	Mar 4, 2013		DISCN	No	No
Gland	ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	204217-001	Aug 18, 2016	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	4,777,163
Sandoz	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007	4,939,130*PED
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011	4,939,130*PED
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003	4,939,130*PED

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/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
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
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
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

International Patents for ZOLEDRONIC ACID

Country	Patent Number	Title	Estimated Expiration
South Korea	101015718
Japan	4802096
Brazil	PI0414562	produtos farmacêuticos contendo bisfosfonatos
Peru	20050468	PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS

Supplementary Protection Certificates for ZOLEDRONIC ACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591122	132013902140458	Italy		PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
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	01C0035	France		PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 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

ZOLEDRONIC ACID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Zoledronic Acid

Market Overview

Zoledronic acid, commonly known by the brand name Reclast, is a bisphosphonate drug used to treat various bone-related conditions, including osteoporosis, metastatic bone cancers, and systemic metabolic bone diseases. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The zoledronic acid market is projected to experience significant growth. By 2027, the market size is estimated to reach $2.83 billion, growing at a Compound Annual Growth Rate (CAGR) of 5.1% from 2022 to 2027[1][4].

Geographical Distribution

Geographically, North America dominated the zoledronic acid market in 2021, driven by robust medical infrastructure and high awareness of medical products. However, the Asia-Pacific region is expected to offer lucrative growth opportunities due to the rising prevalence of cancer and other bone-related diseases[1][4].

Market Segmentation

By Application

The zoledronic acid market is segmented into several applications, including metastatic bone cancers, systemic metabolic bone diseases, osteoporosis, Paget’s disease, and others. The osteoporosis 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. This is largely due to the high prevalence of osteoporosis, especially in postmenopausal women and patients on glucocorticoids[1].

By Distribution Channel

The market is also segmented by distribution channels into offline and online modes. Offline channels, such as pharmacy stores and medical stores, held a dominant market share in 2021 due to the easy availability of drugs through these channels[1].

Market Drivers

Several factors drive the growth of the zoledronic acid market:

• Increasing Prevalence of Bone Diseases: The rising cases of osteoporosis, particularly in postmenopausal women, and other bone-related diseases are key drivers[1][4].
• Efficacy in Reducing Bone-Related Events: Zoledronic acid's efficacy in reducing the recurrence of giant cell tumors of bone and preventing skeletal-related events in cancer patients is a significant driver[1][5].
• Healthcare Expenditure: Increased healthcare expenditure and government support for research and development are vital factors escalating market growth[4].

Market Restraints

Despite the growth drivers, there are several restraints to the market:

• Stringent Regulations: Strict regulatory requirements can hinder the market growth.
• Availability of Alternatives: The presence of substitute drugs such as denosumab, alendronate, risedronate, and ibandronate acts as a major restraint[1][4].

Cost-Effectiveness

Zoledronic acid is generally more cost-effective compared to other treatments like denosumab. For instance, the average cost of zoledronic acid, including IV administration, is approximately $140 per dose, whereas denosumab costs around $1,828 per dose. Studies have shown that zoledronic acid administered every 3 months is more cost-effective than monthly denosumab in reducing skeletal-related events[2][5].

Financial Trajectory

Revenue Projections

The global zoledronic acid market is expected to grow significantly, with revenue projections indicating a market size of $2.83 billion by 2027. This growth is supported by the increasing prevalence of bone diseases and the rising healthcare expenditure[1][4].

Cost Comparison

Zoledronic acid is priced around $1,250 per annual dose, which is less expensive than some other bisphosphonates like intravenous ibandronate but more expensive than oral bisphosphonates. However, its long-term cost-effectiveness, especially when administered every 3 months, makes it a viable option for many patients[2][5].

Industry Outlook

The zoledronic acid market is characterized by various strategic activities among key players:

• Product Launches and Mergers: Companies like Cipla, Emcure Pharmaceutical, and Teva Pharmaceutical Industry Ltd are involved in product launches, mergers, and acquisitions to strengthen their market presence[1].
• Geographical Expansions: There is a focus on expanding into new geographical regions, particularly in the Asia-Pacific, where there is a rising demand for bone-related treatments[1][4].

Key Players

The top companies in the zoledronic acid market include:

• Cipla
• Emcure Pharmaceutical
• Hangzhou Longshine Bio-Tech
• Lianyungang Runzhong Pharm
• Mylan Pharms Inc
• Natco Pharma Ltd
• Scinopharm Taiwan Ltd
• Taj Pharmaceutical Ltd
• Tecoland Corp
• Teva Pharmaceutical Industry Ltd[1].

Conclusion

The zoledronic acid market is poised for significant growth driven by the increasing prevalence of bone diseases, its efficacy in treatment, and cost-effectiveness. Despite the presence of alternative treatments, zoledronic acid remains a dominant player in the market due to its long-term benefits and lower costs compared to some other treatments.

Key Takeaways

• The zoledronic acid market is projected to reach $2.83 billion by 2027, growing at a CAGR of 5.1%.
• North America dominates the market, but the Asia-Pacific region offers lucrative growth opportunities.
• The osteoporosis segment is the fastest-growing application segment.
• Zoledronic acid is more cost-effective than denosumab in reducing skeletal-related events.
• Key players are engaging in product launches, mergers, and geographical expansions.

FAQs

What is the projected market size of zoledronic acid by 2027?

The zoledronic acid market is estimated to reach $2.83 billion by 2027[1].

What is the CAGR of the zoledronic acid market from 2022 to 2027?

The market is expected to grow at a CAGR of 5.1% from 2022 to 2027[1].

Which region dominates the zoledronic acid market?

North America currently dominates the market, but the Asia-Pacific region is expected to offer significant growth opportunities[1][4].

What are the main applications of zoledronic acid?

The main applications include metastatic bone cancers, systemic metabolic bone diseases, osteoporosis, and Paget’s disease[1].

How cost-effective is zoledronic acid compared to denosumab?

Zoledronic acid is significantly more cost-effective than denosumab, especially when administered every 3 months[2][5].

What are the key drivers of the zoledronic acid market?

Key drivers include the increasing prevalence of bone diseases, efficacy in reducing bone-related events, and rising healthcare expenditure[1][4].