ZOMETA Drug Patent Profile

When do Zometa patents expire, and when can generic versions of Zometa launch?

Zometa is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-nine patent family members in twenty-four countries.

The generic ingredient in ZOMETA 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 Zometa

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

Summary for ZOMETA

International Patents:	39
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	113
Patent Applications:	4,300
Drug Prices:	Drug price information for ZOMETA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOMETA
DailyMed Link:	ZOMETA at DailyMed

See drug prices for ZOMETA

Recent Clinical Trials for ZOMETA

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

Sponsor	Phase
Assiut University	Phase 3
Australian and New Zealand Intensive Care Research Centre	Phase 2
Lithuanian University of Health Sciences	N/A

See all ZOMETA clinical trials

Paragraph IV (Patent) Challenges for ZOMETA

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

US Patents and Regulatory Information for ZOMETA

ZOMETA 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
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-001	Aug 20, 2001		DISCN	Yes	No
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003		DISCN	Yes	No	8,324,189*PED				Y
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-003	Jun 17, 2011		DISCN	Yes	No	8,324,189*PED				Y

Expired US Patents for ZOMETA

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
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-002	Mar 7, 2003	4,939,130*PED
Novartis	ZOMETA	zoledronic acid	INJECTABLE;INTRAVENOUS	021223-001	Aug 20, 2001	4,777,163

EU/EMA Drug Approvals for ZOMETA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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

International Patents for ZOMETA

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

Country	Patent Number	Title	Estimated Expiration
Australia	6128301	Method of administering a bisphosphonate
China	1852739	Pharmaceutical products comprising bisphosphonates
Taiwan	200522969	Pharmaceutical products comprising bisphosphonates

Supplementary Protection Certificates for ZOMETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0258618	2001C/036	Belgium		PRODUCT NAME: ACIDE ZOLEDRONIQUE; NATL REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
0258618	26/2001	Austria		PRODUCT NAME: ZOLEDRONSAEURE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463 20001128
0275821	C300058	Netherlands		PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF SOLVAAT, IN HET BIJZONDER ZOLEDRONINE-ZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320

Zoledronic Acid (ZOMETA) Market Dynamics and Financial Trajectory

Market Overview

Zoledronic acid, commonly known by the brand name ZOMETA or Reclast, is a bisphosphonate drug used to treat various bone-related conditions, including osteoporosis, high blood calcium levels, and bone metastases. The market for zoledronic acid is poised for significant growth driven by several key factors.

Market Size and Growth

The global 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].

Geographical Segmentation

Geographically, North America held a dominant share of the zoledronic acid market in 2021, attributed to the 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][3].

Market Drivers

Several factors drive the growth of the zoledronic acid market:

• Increasing Prevalence of Bone Diseases: The rising cases of osteoporosis and bone metastases, particularly in the aging population, are significant drivers. According to the US CDC, approximately 200 million people suffer from osteoporosis, and nearly one in every three women will experience an osteoporotic fracture[1][3].
• Growing Awareness and Medical Literacy: Increased awareness about bone health, especially among post-menopausal women, is driving the adoption of zoledronic acid. Government and healthcare organizations' efforts to educate the population about bone-related diseases also contribute to market growth[1][3].
• Efficacy in Reducing Skeletal-Related Events: Zoledronic acid's efficacy in reducing the recurrence of giant cell tumors of bone and skeletal-related events (SREs) is a key market driver[1].

Market Restraints

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

• Stringent Regulations: Complex regulatory requirements pose challenges for market growth.
• Availability of Alternatives: The presence of alternative drug classes, such as denosumab, and potential side effects associated with zoledronic acid are significant market hurdles[1][3].
• High Treatment Costs: The high cost of zoledronic acid treatment, approximately $1,250 per dose given once a year, can be a deterrent for some patients[5].

Distribution Channel Analysis

The zoledronic acid market is segmented into offline and online distribution channels. The offline segment held a dominant market share in 2021 due to the easy availability of drugs from pharmacy stores and medical stores enrolled in insurance structures. However, the online segment is expected to grow at a CAGR of 6.0% over the forecast period, driven by discounts and cashback offers from online pharmacies[1].

Cost-Effectiveness and Comparative Analysis

A study comparing denosumab with zoledronic acid in preventing skeletal-related events (SREs) found that while denosumab was more effective, it was not cost-effective due to its higher costs. During a 1-year treatment period, denosumab incurred $7,522 higher costs compared to zoledronic acid, leading to an incremental total cost per SRE avoided of $114,628[2].

Industry Outlook and Key Players

The zoledronic acid market is characterized by the presence of several key players, including Cipla, Emcure Pharmaceutical, Hangzhou Longshine Bio-Tech, and Teva Pharmaceutical Industry Ltd. These companies are engaged in product launches, mergers and acquisitions, joint ventures, and geographical expansions to enhance their market presence[1].

SWOT Analysis

• Strengths: Zoledronic acid offers long-lasting effects and high efficacy in treating bone-related conditions, with a well-established market presence.
• Weaknesses: High treatment costs and complex regulatory requirements.
• Opportunities: Exploring new applications beyond osteoporosis and bone metastases, and leveraging personalized medicine and targeted therapies.
• Threats: Competition from alternative treatment options and potential side effects associated with zoledronic acid[3].

Financial Trajectory

The financial trajectory of the zoledronic acid market is promising, driven by increasing healthcare expenditure and growing awareness about bone health. The market is expected to generate significant revenue through the development and sale of zoledronic acid products. Regulatory approvals of generic versions of zoledronic acid are also expected to increase market competition and drive down costs for patients[1][3].

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.
• Increasing prevalence of bone diseases and growing awareness about bone health are key market drivers.
• High treatment costs and stringent regulations are significant market restraints.
• The online distribution channel is expected to grow rapidly due to discounts and cashback offers.

Frequently Asked Questions (FAQs)

1. What is the primary use of zoledronic acid? Zoledronic acid is primarily used to treat high blood calcium levels, osteoporosis, and to prevent or treat bone metastases.

2. What is the estimated market size of zoledronic acid by 2027? The zoledronic acid market is estimated to reach $2.83 billion by 2027.

3. Which region is expected to offer the most growth opportunities for the zoledronic acid market? The Asia-Pacific region is expected to offer lucrative growth opportunities due to the rising prevalence of cancer and other bone-related diseases.

4. How does the cost of zoledronic acid compare to other bisphosphonates? Zoledronic acid costs approximately $1,250 per dose, given once a year, which is less than one year of intravenous ibandronate but more than one year of oral bisphosphonates given monthly[5].

5. What are the key strategies adopted by players in the zoledronic acid market? Players in the zoledronic acid market adopt strategies such as product launches, mergers and acquisitions, joint ventures, and geographical expansions to enhance their market presence[1].

Cited Sources:

1. IndustryARC, Zoledronic Acid Market - Forecast(2024 - 2030)
2. PubMed, Cost-effectiveness of denosumab compared with zoledronic acid in ...
3. MarkWide Research, Zoledronic Acid Market 2024-2032 | Size, Share, Growth
4. Straits Research, Osteoporosis Drugs Market Size to Reach $12.12 billion by 2031
5. American Academy of Family Physicians, Zoledronic Acid (Reclast) for Osteoporosis