RECLAST Drug Patent Profile

When do Reclast patents expire, and what generic alternatives are available?

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-two 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECLAST

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

International Patents for RECLAST

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

Country	Patent Number	Title	Estimated Expiration
Ireland	59816	Novel substituted alkanediphosphonic acids
Singapore	92194
Cyprus	1827	Substituted alkanediphosphonic acids
Mexico	PA02012682	METODO PARA ADMINISTRAR BISFOSFONATOS. (METHOD OF ADMINISTERING BISPHOSPHONATES.)
Australia	2004271731	Pharmaceutical products comprising bisphosphonates
South Korea	20030015283

Supplementary Protection Certificates for RECLAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0275821	2001C/035	Belgium		PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
1591122	CA 2013 00016	Denmark		PRODUCT NAME: ZOLEDRONSYRE ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET VILKARLIGT HYDRAT DERAF; NAT. REG. NO/DATE: EU/1/05/308, C(2007)4619 20071003; FIRST REG. NO/DATE: CH 57363 20070927
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	27/2001	Austria		PRODUCT NAME: ZOLEDRONSAEURE UND DEREN SALZE UND HYDRATE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463.01 20001128
1591122	92174	Luxembourg		PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
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

RECLAST: Patent Landscape and Investment Outlook

Last updated: February 19, 2026

RECLAST (zoledronic acid) is an intravenous bisphosphonate used for treating osteoporosis and hypercalcemia of malignancy. Its intellectual property landscape is characterized by expiring composition of matter patents and ongoing patent challenges related to manufacturing processes and specific therapeutic uses. The drug's established efficacy and broad patient indication support continued market demand, despite generic competition.

What are the Key Patents Governing RECLAST?

The primary patent protecting RECLAST's core composition of matter was U.S. Patent No. 4,939,130, which expired on August 12, 2008. This patent covered zoledronic acid itself. Subsequent patents have focused on crystalline forms, manufacturing processes, and specific therapeutic indications.

• U.S. Patent No. 4,939,130: Composition of matter for zoledronic acid. Expired August 12, 2008.
• U.S. Patent No. 5,869,467: Crystalline forms of zoledronic acid. Expired December 28, 2016.
• U.S. Patent No. 7,018,811: Method of treating bone metastases. Expired March 28, 2023.
• U.S. Patent No. 7,615,544: Methods for manufacturing zoledronic acid. Remaining term until October 13, 2026.

The expiration of the foundational composition of matter patent has enabled generic versions of RECLAST to enter the market. However, patents related to manufacturing processes and specific delivery methods can still offer a degree of market exclusivity for the innovator product and provide grounds for litigation.

What is the Current Market Status of RECLAST?

RECLAST, marketed by Novartis, faces significant generic competition following the expiration of its core patent. The drug is prescribed for osteoporosis in postmenopausal women, osteoporosis in men, and glucocorticoid-induced osteoporosis. It is also indicated for treating hypercalcemia of malignancy and for reducing skeletal-related events in patients with bone metastases from solid tumors.

Indication	Patient Population	Market Share Impacted by Generics
Osteoporosis (postmenopausal women)	Postmenopausal women	High
Osteoporosis (men)	Men	High
Glucocorticoid-induced osteoporosis	Patients on long-term glucocorticoid therapy	Moderate
Hypercalcemia of malignancy	Cancer patients with elevated calcium levels	Moderate
Skeletal-related events (bone metastases)	Cancer patients with bone metastases (e.g., breast, multiple myeloma)	Moderate

Global sales of branded RECLAST have declined significantly due to generic entry. For instance, in 2022, Novartis reported net sales of approximately $932 million for zoledronic acid products, a decrease from previous years, reflecting the impact of generic erosion and competitive pressures. [1]

What is the Competitive Landscape for Zoledronic Acid?

The competitive landscape for zoledronic acid is dominated by generic manufacturers. These companies offer bioequivalent versions of RECLAST, typically at lower price points, driving down the overall market value for the drug.

• Generic Zoledronic Acid: Multiple pharmaceutical companies have received FDA approval for generic versions of zoledronic acid injection. Examples include manufacturers like Teva Pharmaceuticals, Mylan, and Sandoz.
• Oral Bisphosphonates: RECLAST competes indirectly with oral bisphosphonates such as alendronate (FOSAMAX), risedronate (ACTONEL), and ibandronate (BONIVA). These are often preferred by patients due to ease of administration, though they may have different efficacy profiles and side effect considerations.
• Other Osteoporosis Therapies: The market also includes newer classes of osteoporosis treatments, such as denosumab (PROLIA), teriparatide (FORTEO), and romosozumab (EVENITY), which offer alternative mechanisms of action and are used for specific patient populations or when bisphosphonates are contraindicated or ineffective.

The efficacy and safety profile of zoledronic acid, particularly its annual infusion regimen for osteoporosis, provides a differentiated treatment option compared to some oral alternatives, which often require weekly or monthly dosing. This dosing advantage can contribute to continued, albeit diminished, market share for the branded product and its generics.

What are the Key Manufacturing and Process Patents?

While the composition of matter patent has expired, patents covering specific manufacturing processes for zoledronic acid remain relevant. These patents can present barriers to entry for generic manufacturers if they are broad enough to cover essential steps in the synthesis of zoledronic acid or specific polymorphic forms.

U.S. Patent No. 7,615,544, which claims methods for manufacturing zoledronic acid, remains in force until October 13, 2026. Litigation surrounding such process patents is common in the pharmaceutical industry, with generic companies seeking to design around existing patents or challenge their validity. Successful challenges can accelerate generic market entry.

For example, Hatch-Waxman Act litigation often involves disputes over whether a generic product infringes an existing patent or if that patent is invalid. The outcome of these legal proceedings directly impacts the market exclusivity of both innovator and generic products.

What is the Future Outlook for Zoledronic Acid?

The future outlook for zoledronic acid is characterized by continued generic competition and a stable, albeit declining, market for the innovator product. Its established role in managing osteoporosis and hypercalcemia ensures ongoing demand.

• Sustained Demand in Established Indications: Zoledronic acid remains a first-line or second-line therapy for osteoporosis and is crucial in managing bone complications of cancer. This established clinical utility will support sustained prescription volumes.
• Price Erosion: The presence of multiple generic manufacturers will continue to drive down prices, impacting overall revenue for both branded and generic products.
• Potential for New Formulations or Indications: While less likely for a mature drug, research into novel delivery systems or expanded therapeutic uses could potentially create new market opportunities. However, the focus for zoledronic acid is largely on optimizing its existing applications.
• Patent Expirations: The remaining process patents will eventually expire, leading to complete market liberalization for zoledronic acid manufacturing.

The market for zoledronic acid will continue to be driven by its clinical value proposition, cost-effectiveness compared to some newer therapies, and the long-term experience with its safety and efficacy profile.

Key Takeaways

RECLAST's patent life cycle has transitioned from composition of matter exclusivity to reliance on process and formulation patents. The expiration of its primary patent has led to significant generic market penetration, resulting in price erosion. Despite this, RECLAST's established therapeutic benefits in osteoporosis and oncology support continued market relevance, albeit with reduced revenue for the innovator product. Ongoing patent disputes related to manufacturing processes can influence the pace of generic market entry and pricing strategies.

Frequently Asked Questions

What is the typical dosing regimen for RECLAST in osteoporosis?

RECLAST is typically administered as a 5 mg intravenous infusion once a year for the treatment of osteoporosis.

Are there significant side effects associated with RECLAST?

Common side effects include flu-like symptoms, fever, muscle pain, and fatigue, which usually occur shortly after infusion. More serious side effects, though rare, include osteonecrosis of the jaw and atypical fractures of the femur.

How does RECLAST compare in efficacy to oral bisphosphonates for osteoporosis?

Studies have shown that RECLAST has comparable or superior efficacy to oral bisphosphonates in reducing fracture risk, particularly vertebral fractures. Its annual infusion schedule also offers a compliance advantage for some patients.

What is the primary mechanism of action for zoledronic acid?

Zoledronic acid is a potent bisphosphonate that inhibits osteoclast activity, thereby reducing bone resorption and increasing bone mineral density.

What is the current pricing trend for generic zoledronic acid?

Pricing for generic zoledronic acid is highly competitive and has seen substantial declines since the initial market entry of generics. Prices vary depending on the manufacturer, volume, and payer contracts.

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Citations

[1] Novartis AG. (2023). Novartis Annual Report 2022. Retrieved from https://www.novartis.com/sites/default/files/2023-02/novartis-annual-report-2022.pdf