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-four 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:	2
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	27
Patent Applications:	3,915
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/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
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
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

International Patents for RECLAST

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

Country	Patent Number	Title	Estimated Expiration
Poland	358224
Japan	4802096
South Korea	100864743
Japan	2005247873	METHOD OF ADMINISTERING BISPHOSPHONATES
Luxembourg	92174
European Patent Office	1296689	METHODE D'ADMINISTRATION DE BISPHOSPHONATES (METHOD OF ADMINISTERING BISPHOSPHONATES)

Supplementary Protection Certificates for RECLAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591122	300582	Netherlands		PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
0275821	2001C/035	Belgium		PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
1591122	122013000031	Germany		PRODUCT NAME: ZOLEDRONSAEURE ODER PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER BELIEBIGES HYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/05/308/001-002 20071003; FIRST REGISTRATION: SCHWEIZ 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
1591122	92174	Luxembourg		PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI

Market Dynamics and Financial Trajectory for Reclast (Zoledronic Acid)

Overview of Reclast (Zoledronic Acid)

Reclast, known generically as zoledronic acid, is a bisphosphonate drug widely used for treating conditions such as hypercalcemia of malignancy, osteolytic bone lesions of multiple myeloma, osteolytic bone metastases of solid tumors, and osteoporosis. It is marketed by Novartis Pharmaceuticals Corp.[2].

Market Size and Growth Projections

The zoledronic acid market is projected to grow significantly over the forecast period of 2022-2027. The market size is estimated to reach $2.83 billion by 2027, with a Compound Annual Growth Rate (CAGR) of 5.1% during this period[1].

Key Drivers of the Market

Increasing Prevalence of Bone Diseases

The rising cases of bone diseases, particularly osteoporosis, are major drivers for the zoledronic acid market. Osteoporosis affects approximately 200 million people globally, with nearly one in every three women experiencing osteoporotic fractures. This increasing prevalence, coupled with growing awareness about post-menopausal women's health, is driving the demand for zoledronic acid[1].

Efficacy in Reducing Fractures

Clinical studies have shown that zoledronic acid is highly effective in reducing the incidence of fractures in women with postmenopausal osteoporosis. For instance, a study revealed a 70% reduction in the risk of spinal fractures and a 40% reduction in the risk of hip fractures over a three-year period[5].

Geographical Market Dynamics

Geographically, North America held a dominant share of the zoledronic acid market in 2021, primarily due to robust medical infrastructure and high awareness of medical products. However, the Asia-Pacific region is expected to offer lucrative growth opportunities due to the increasing prevalence of cancer and other bone-related diseases[1].

Market Segmentation Analysis

By Distribution Channel

The zoledronic acid market can be segmented into offline and online distribution channels. The offline channel dominated the market in 2021, thanks to the easy availability of drugs from pharmacy stores and the integration of medical stores into 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 that enhance market traction[1].

By Indication

The osteoporosis segment is projected to be the fastest-growing, with a CAGR of 5.8% over the forecast period. This growth is attributed to the high prevalence of osteoporosis and increasing medical literacy among women, which leads to better adoption of zoledronic acid[1].

Financial Aspects

Pricing and Cost

The cost of Reclast (zoledronic acid) can vary significantly depending on the pharmacy and the presence of discounts or insurance plans. For example, the intravenous solution of Reclast (5 mg/100 mL) can cost around $1,388 for a supply of 100 milliliters. However, generic versions of zoledronic acid are available at lower prices, starting from $111.50 for 100 milliliters[2].

Discount Programs and Patient Assistance

To make the drug more affordable, various discount programs and patient assistance plans are available. For instance, the Drugs.com Discount Card can save patients up to 80% on prescription medicines, including Reclast[2].

Competitive Landscape and Generic Impact

The osteoporosis drugs market, including zoledronic acid, is seeing a significant impact from generic versions. As patents for branded drugs expire, generic drugs are becoming more prevalent, leading to price decreases and increased demand. Government regulations promoting the use of generics in public healthcare facilities further contribute to this trend[4].

Challenges and Hurdles

Despite the growth potential, the zoledronic acid market faces challenges such as stringent regulations and the availability of alternative or substitute drug classes. These factors can hinder market growth and adoption rates[1].

Expert Insights and Clinical Impact

According to Dennis Black, PhD, a professor of epidemiology and biostatistics at the UCSF School of Medicine, "The reductions in hip and spine fractures were at least as large as those seen with other drugs in this category." This underscores the clinical efficacy and significant impact of zoledronic acid in treating osteoporosis[5].

Key Takeaways

• The zoledronic acid market is projected to reach $2.83 billion by 2027, growing at a CAGR of 5.1%.
• The drug is highly effective in reducing fractures in women with postmenopausal osteoporosis.
• North America dominates the market, but Asia-Pacific offers significant growth opportunities.
• Online distribution channels are expected to grow rapidly due to discounts and cashback offers.
• Generic versions of zoledronic acid are becoming more prevalent, reducing costs and increasing demand.

FAQs

What is Reclast (zoledronic acid) used for?

Reclast (zoledronic acid) is used to treat high blood calcium levels, osteoporosis, and other bone-related conditions such as osteolytic bone lesions and metastases.

How effective is Reclast in reducing fractures?

Reclast has been shown to reduce the risk of spinal fractures by 70% and hip fractures by 40% over a three-year period in women with postmenopausal osteoporosis.

What is the current market size and growth projection for zoledronic acid?

The zoledronic acid market is estimated to reach $2.83 billion by 2027, growing at a CAGR of 5.1% from 2022 to 2027.

How does the distribution channel impact the market?

The offline distribution channel currently dominates, but the online segment is expected to grow faster due to discounts and cashback offers.

Are there generic versions of Reclast available?

Yes, generic versions of zoledronic acid are available, significantly reducing the cost compared to the branded version.

Sources

1. IndustryARC: Zoledronic Acid Market - Forecast(2024 - 2030)
2. Drugs.com: Reclast Prices, Coupons, Copay Cards & Patient Assistance
3. UCSF: Once-a-year drug reduces fractures from osteoporosis
4. Grand View Research: Osteoporosis Drugs Market Size And Share Report, 2030