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-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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	27
Patent Applications:	4,860
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	7,932,241*PED				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	8,052,987

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/002667Prevention 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/002488Prevention 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/002482Prevention 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/0023654 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/002439Prevention 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/000595Treatment 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
Austria	72816
Australia	607722
Australia	8145387
Canada	1338937	METHODE POUR LA PREPARATION DE NOUVEAUX DERIVES DE SUBSTITUTION D'ACIDES ALCANEDIPHOSPHONIQUES (PROCESS FOR THE MANUFACTURE OF NOVEL SUBSTITUTED ALKANEDIPHOSPHONIC ACIDS)
Cyprus	1827	Substituted alkanediphosphonic acids
German Democratic Republic	270533	VERFAHREN ZUR HERSTELLUNG NEUER SUBSTITUIERTE ALKANDIPHOSPHONSAEUREN

Supplementary Protection Certificates for RECLAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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
0275821	2001C/035	Belgium		PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
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

RECLAST (zoledronic acid) market dynamics, patent/competition-driven risks, and financial trajectory

Last updated: July 26, 2026

Reclast (zoledronic acid) tracks to long-running, lower-cost competition dynamics tied to (1) loss of exclusivity on older reference and formulation patents, and (2) a mature biospar? not applicable (small molecule) generic and branded-supply structure. Revenue resilience typically comes from inertia in infusion ordering, clinical guideline entrenchment in osteoporosis and fracture-prevention, and payer comfort with established dosing regimens, but price pressure is structurally ongoing in the US and EU as additional generic entries consolidate share. The financial trajectory is best modeled as a mature brand: modest growth tied to uptake and new indications, then step-down during generic substitution cycles and periodic channel resets from wholesalers.

What is RECLAST and what does it treat across osteoporosis and fracture prevention markets?

Featured answer: Reclast is an IV zoledronic acid bisphosphonate used for osteoporosis and related fracture-risk reduction and, in selected markets, Paget’s disease and other bone-metabolism indications.

Reclast commercial footprint is anchored in high-volume indications where clinicians use a once-yearly infusion model versus more frequent oral bisphosphonates. That dosing convenience supports adherence and persistence, which helps explain why branded pricing holds longer than would be expected for a small molecule.

Indication demand drivers that move prescribing volume

• Postmenopausal osteoporosis and prevention of vertebral and hip fractures: stable base demand across aging demographics.
• Glucocorticoid-induced osteoporosis: intermittent payer prioritization and switching.
• Men’s osteoporosis: smaller but steady niche volume.
• Paget’s disease (where marketed): more episodic but can support periodic demand spikes.

Market structure implications

• Infusion administration concentrates prescribing into settings with established protocols (hospital outpatient, infusion centers, specialty clinics), which slows substitution versus office-administered self-care products.
• Formularies often adopt step-therapy behavior between branded and lower-cost generics, particularly when wholesale pricing or acquisition costs compress.

How does RECLAST’s competitive landscape shape pricing and market share in 2024–2026?

Featured answer: Generic substitution is the dominant share driver for a mature small-molecule infusion product; branded resilience depends on contracting mechanics and channel inventory cycles rather than patent barriers.

US market dynamics

• Zoledronic acid IV is a mature small molecule. Competitive pressure is primarily from authorized or unapproved generics (and distribution brand-specific contracting).
• Payer behavior typically shifts from “brand preference” to “lowest net cost after rebates” once multiple generics are established.
• Provider behavior can lag due to clinic standardization, infusion workflow setup, and existing buy-and-bill inventory.

EU/UK market dynamics

• EU pricing tends to face stronger tender pressure, local generic penetration, and periodic reimbursement resets.
• National HTA decisions and tendering can create short-lived branded demand pockets before reset by reference pricing.

Key market levers that affect near-term revenue

• Net price: driven by rebates, wholesaler fees, and payer contracting.
• Volume: influenced by guideline adherence, clinician preference for annual dosing, and patient adherence outcomes.
• Channel inventory: impacts quarterly revenue recognition during generic entry waves.
• Supply reliability: infusion products can see short disruptions that temporarily favor available brands, then revert.

What are the patent and exclusivity risks that influence RECLAST revenue?

Featured answer: For a legacy bisphosphonate like zoledronic acid marketed as Reclast, revenue is most sensitive to generic substitution cycles and any remaining formulation, method-of-use, or lifecycle patents rather than long-running sole-compound exclusivity.

How generic entry typically impacts revenue trajectory

• First wave: share loss often starts modestly, then accelerates when payers and providers standardize to lower acquisition-cost products.
• Second wave: incremental generic entrants can further compress net price even if total volume remains stable.

Patent estate categories that matter for Reclast

1. Formulation or dosing-form patents (e.g., container/administration system, stability, or specific preparation steps).
2. Method-of-use patents tied to fracture-prevention populations, dosing schedules, or risk-based regimens.
3. Manufacturing/process improvements (lower-latent barrier manufacturing claims can matter in certain jurisdictions if asserted).
4. Pediatric or specific demographic lifecycle claims where applicable.

When does RECLAST lose exclusivity, and how does that timing map to generic launch risk?

Featured answer: Reclast’s practical exclusivity headwinds are already in the mature phase; the financial risk is less about a single cliff date and more about recurring generic consolidation and lifecycle patent challenges that shift contracting behavior.

Because RECLAST is long established, the relevant question for revenue forecasting is not “when does the last composition patent expire” in abstract, but “when do remaining formulation or method-of-use patents fall” in the jurisdictions that matter for major procurement and reimbursement. That timing translates into predictable phases:

• pre-launch uncertainty (volume holds but contracting tightens),
• launch substitution (share and price both drop),
• settling period (volume stabilization, further rebate compression).

How many patents cover RECLAST and what is the strength of the patent estate?

Featured answer: A mature product with multiple lifecycle patent families usually has a non-trivial number of listed patents, but strength is assessed by enforceability in asserted claims and nexus to the marketed formulation and dosing.

Patent strength indicators that affect financial trajectory

• Narrow claim scope that tracks specific manufacturing steps is harder for generics to work around without potential design-around.
• Claims tied to well-defined dosing regimens can slow substitution if generics attempt to market “do not infringe” labeling but payers see equivalent therapeutic outcomes.
• Broad method-of-use claims can raise litigation risk and delay certain carve-outs but often face anticipation/obviousness pressure for legacy therapies.

Litigation posture and settlement-driven outcomes

For established small molecules, settlements tend to produce:

• defined at-risk or non-at-risk launch dates,
• distribution carve-outs,
• label or presentation restrictions.

Those terms can shape short-term revenue variance even after exclusivity ends.

What is the Orange Book status of RECLAST, and how does that affect Paragraph IV challenges?

Featured answer: Orange Book status drives generic filing mechanics and timing. For Reclast, Orange Book dynamics matter mainly for listing-based barriers and settlement-driven launch calendars, not for maintaining long-term branded pricing.

Orange Book-listed patents influence:

• the willingness of generics to file Paragraph IV certifications,
• the probability of litigation and delay,
• the label and indication scope of generic entry.

Paragraph IV risk translation to financials

• If Orange Book listings are reduced or allowed during prosecution, later generics can launch earlier without litigation delays.
• If listed patents are successfully enforced or lead to settlements, branded cash flows can persist longer via delayed entry.

What formulations are protected for RECLAST, and what does that mean for generic substitution?

Featured answer: For infusion drugs like Reclast, the practical substitution target is the same active ingredient and route with bioequivalence, while formulation and container-related patents can create localized barriers if claims are enforceable and directly overlap with generic products.

Formulation protection themes

• Stability and container-closure system claims: can restrict generic presentation if courts treat the design as materially linked.
• Administration system claims: sometimes affect “how” rather than “what,” creating litigation leverage for a settlement.
• Specific dilution/preparation workflows: can be relevant if dosing preparation is claimed and linked to labeling.

Commercial translation

Even when a generic can legally enter, payer adoption can be delayed if pharmacy and infusion workflows prefer a standardized product or if contracting still favors the reference brand.

How does RECLAST compare with competing bisphosphonates and alternative osteoporosis agents?

Featured answer: Reclast faces substitution not only from zoledronic acid generics but also from alternative classes (other bisphosphonates, denosumab, and anabolic agents) based on patient risk stratification and reimbursement preference.

Bisphosphonate cross-competition

• Oral bisphosphonates: compete on acquisition cost but can lose versus annual IV adherence benefit for some patient segments.
• Other IV options: can compete on convenience, dosing frequency, and net cost.

Denosumab and anabolic therapy pressure

• Denosumab’s different mechanism and dosing cadence can shift prescribing for higher-risk patients.
• Anabolics can capture a share of “very high risk” and prior fracture segments, potentially diluting Reclast volume growth even if total osteoporosis treatment volume increases.

What generic entry risks exist for RECLAST in key jurisdictions?

Featured answer: Generic entry risk is concentrated in countries where reimbursement and procurement quickly move to reference pricing and where enough generic capacity exists to sustain infusion supply at low cost.

Risk drivers

• Regulatory approval timelines for generics once clinical and bioequivalence requirements are satisfied.
• Supply chain readiness: infusion manufacturing scale and batch availability.
• Tender rules: awarding tends to favor lowest net cost, reducing branded price flexibility.

Revenue exposure mapping

• Higher exposure where Reclast has greater insurer penetration and where tendering is active.
• Lower exposure where clinicians maintain established protocols that keep usage anchored despite price differences.

What FDA and regulatory milestones affect RECLAST’s commercial trajectory?

Featured answer: For established products, FDA milestones mainly affect labeling, safety monitoring, and product quality changes rather than approval-driven growth.

Key milestone categories for annual infusion drugs:

• label updates for safety communications,
• manufacturing site changes that can affect supply continuity,
• changes to distribution arrangements or packaging that alter wholesaler ordering patterns.

Regulatory developments can cause short-term distribution disruptions or temporary inventory rebalancing that affects recognized revenue.

What patent litigation affects RECLAST, and how do settlements change forecasts?

Featured answer: Litigation and settlements typically impact launch calendars and payer contracting timelines more than they affect long-run medical use. For mature small molecules, settlement outcomes can create discrete quarter-to-quarter revenue swings.

Forecasting mechanics for litigation

• Delay-to-launch: keeps branded share temporarily higher.
• Carve-outs: restrict generic entry to certain strengths or presentations, allowing partial continued branded utilization.
• Design-around permissions: may permit earlier entry if generics can avoid asserted claims.

Settlement-driven market behavior

• Payers update formularies only when product availability stabilizes and safety equivalence is established.
• Providers may keep using the brand briefly while switching infusion workflows.

How does RECLAST’s financial trajectory typically evolve across the brand lifecycle?

Featured answer: The mature product pattern is: steady volume near the upper range early, followed by step-down in net price and gradually declining share after generic consolidation, with occasional stabilization from contracts and infusion-center standardization.

Revenue model structure for Reclast

1. Base demand tied to osteoporosis incidence and guideline-driven treatment rates.
2. Share component tied to branded net cost versus generic contracted price.
3. Contract cycle component tied to payer and provider procurement resets.
4. Inventory and supply availability component tied to manufacturing continuity.
5. Indication mix component tied to segment-level prescribing changes and alternative therapy adoption.

What to watch in financial reporting

• Gross-to-net changes: rebate pressure is a leading indicator of genericization.
• ASP declines: reflect contracting and wholesaler pricing.
• Volume stability: indicates whether branded persistence is driven by clinical workflow versus pure price.
• Mix shifts: aging demographics and “very high risk” treatments can shift distribution across osteoporosis subpopulations.

Which companies are likely to compete with RECLAST, and how does that affect revenue risk?

Featured answer: Revenue risk concentrates among generic zoledronic acid IV suppliers and any authorized competitors with strong infusion distribution channels.

Competitive behavior patterns

• Aggressive contracting with payers: accelerates share loss.
• Stable supply commitments: supports rapid substitution because providers do not fear stockouts.
• Marketing and contracting at infusion centers: can override inertia when net cost crosses thresholds.

Key Takeaways

• Reclast is a mature, once-yearly IV zoledronic acid product where the dominant financial driver is generic substitution and contracting, not new patent-protected growth.
• Market share and net price pressure typically follow generic launch cycles; volume can remain comparatively stable if clinical workflows are entrenched.
• Patent and Orange Book dynamics matter primarily for launch timing, settlement-driven entry calendars, and any residual formulation/method-of-use barriers.
• Competitive pressure comes from (1) generic zoledronic acid IV products and (2) alternative osteoporosis therapies that capture higher-risk segments.
• Financial trajectory is best forecast as a contracting-driven, mature-brand model with periodic step changes around entry and procurement resets.

FAQs

1) What happens to Reclast revenue after generic zoledronic acid IV launches?
Expect step-down in net price first, followed by faster share substitution as payers and infusion centers normalize formularies and contracting.

2) Do formulation patents materially block generic entry for Reclast?
They can delay or restrict specific presentations if enforceable, but market substitution usually resumes once equivalent products are available and contracts update.

3) How do method-of-use patents affect prescribing for Reclast?
They can slow adoption where labeling restrictions exist, but prescribing often shifts based on guideline equivalence and payer economics once generics are available.

4) What segment is most sensitive to competitive switching away from Reclast?
Higher-risk patients migrating to denosumab or anabolic therapy can reduce Reclast’s incremental growth even if baseline osteoporosis treatment demand rises.

5) What financial metrics best signal Reclast net price pressure?
Gross-to-net changes, ASP declines, and rebate intensity are early indicators; volume stability versus share loss indicates how much substitution is price versus workflow-driven.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA prescribing information for Reclast (zoledronic acid). U.S. Food and Drug Administration.
3. Agency for Healthcare Research and Quality (AHRQ) and major clinical guideline bodies’ osteoporosis fracture prevention guidance (context for utilization drivers).

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