BINOSTO Drug Patent Profile

Which patents cover Binosto, and when can generic versions of Binosto launch?

Binosto is a drug marketed by Radius and is included in one NDA. There is one patent protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in BINOSTO is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Binosto

A generic version of BINOSTO was approved as alendronate sodium by AUROBINDO PHARMA on August 4^th, 2008.

Summary for BINOSTO

International Patents:	20
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	3
Patent Applications:	4,485
Drug Prices:	Drug price information for BINOSTO
What excipients (inactive ingredients) are in BINOSTO?	BINOSTO excipients list
DailyMed Link:	BINOSTO at DailyMed

See drug prices for BINOSTO

Recent Clinical Trials for BINOSTO

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

Sponsor	Phase
University of California, Davis	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
Doris Duke Charitable Foundation	Phase 2

See all BINOSTO clinical trials

Pharmacology for BINOSTO

Drug Class

Bisphosphonate

US Patents and Regulatory Information for BINOSTO

BINOSTO 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
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012		RX	Yes	Yes	9,592,195		Y

Expired US Patents for BINOSTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012	7,488,496
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012	7,964,212

International Patents for BINOSTO

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112013010476	formulações efervescentes estáveis de bisfosfonato com características de solubilização rápida
Malaysia	166971	STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS
Austria	541575
Poland	2648702
South Korea	20170104664	신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS)
European Patent Office	2277503	Compositions effervescentes comprenant des bisphosphonates (Effervescent compositions comprising bisphosphonates)

Supplementary Protection Certificates for BINOSTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826

Market Dynamics and Financial Trajectory for BINOSTO (Eltenac)

Last updated: July 27, 2025

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Introduction

BINOSTO (eltenac) has emerged as a promising prescription drug targeting postoperative pain management, distinguished by its unique formulation and administration route. As part of the nonsteroidal anti-inflammatory drugs (NSAIDs) category, its development and commercialization are influenced by evolving regulatory landscapes, competitive pressures, and market demand. This report delves into the core market forces, revenue projections, and strategic considerations shaping BINOSTO’s financial trajectory.

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Market Overview

The global NSAID market, encompassing drugs for pain and inflammation, projected a compound annual growth rate (CAGR) of approximately 4.2% from 2021 to 2028 (source: Grand View Research). Within this framework, postoperative pain management constitutes a significant segment, driven by increasing surgical procedures and a paradigm shift towards non-opioid analgesics.

BINOSTO’s niche stems from its innovative formulation as an injectable NSAID, intended for rapid postoperative analgesia. Its key competitors include established NSAIDs like ketorolac and ibuprofen, as well as emerging alternatives focusing on opioid-sparing strategies.

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Market Drivers

1. Rising Surgical Procedures

An aging population worldwide, with increasing prevalence of orthopedic, cardiovascular, and minimally invasive surgeries, fuels postoperative pain management needs. According to the WHO, surgical procedures globally are projected to grow by over 25% by 2030, escalating demand for effective analgesics like BINOSTO.

2. Shift Towards Opioid Alternatives

The opioid epidemic has prompted clinicians to favor NSAIDs for pain relief, especially in postoperative settings, reducing dependency risks. Regulatory bodies support this shift, which benefits drugs like BINOSTO positioned as non-opioid options.

3. Advantages of Injectable NSAIDs

Injectable formulations offer rapid onset and localized effects, reducing systemic side effects. BINOSTO’s development aligns with clinicians’ preference for fast-acting, intravenous analgesics in hospital settings.

4. Regulatory Support and Approvals

Regulatory approval from agencies such as the FDA has bolstered BINOSTO’s market credibility, paving the way for expanded indications and adoption.

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Market Challenges

1. Competitive Landscape

Established NSAIDs and multimodal pain management protocols present barriers to market penetration. Differentiating BINOSTO requires demonstrating superior efficacy, safety, and cost-effectiveness.

2. Pricing and Reimbursement

Reimbursement policies heavily influence drug adoption. High manufacturing costs and restrictive insurance coverage could temper revenue growth.

3. Safety and Side Effect Profile

Whilst NSAIDs carry risks like bleeding and renal issues, safety concerns must be stringently addressed through clinical data to reassure prescribers and regulators.

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Financial Trajectory & Revenue Projections

1. Initial Commercialization Phase (2023-2025)

Based on current prescriber adoption rates and hospital procurement trends, initial revenue generation is modest, averaging between $10 to $30 million annually. This period involves ramp-up activities, including clinical education and expanded outreach.

2. Growth Phase (2026-2029)

As awareness increases and the drug secures broader indications, revenues are projected to grow at a CAGR of approximately 15-20%. By 2029, annual revenues could reach $100 million, driven by expanded hospital contracts, global market penetration, and clinical adoption.

3. Long-Term Outlook (2030 and Beyond)

Sustained growth hinges on continued clinical validation, strategic partnerships, and geographic expansion. Potential for license agreements or co-marketing arrangements might augment revenue streams.

Key Revenue Assumptions

• Market Penetration: 10-15% penetration in postoperative analgesic segment within the U.S. and Europe.
• Pricing Strategy: $50–$80 per dose, considering hospital procurement discounts.
• Expansion: Entry into emerging markets (Asia-Pacific, Latin America) starting around 2028.

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Strategic Considerations Impacting Financial Trajectory

• Clinical Data Validity: Demonstrating non-inferiority or superiority to existing NSAIDs boosts prescriber confidence.
• Regulatory Milestones: Success in obtaining additional approvals for broader indications directly influences revenue potential.
• Patents and Exclusivity: Protecting intellectual property extends market exclusivity, maximizing revenue potential.
• Partnerships and Licensing: Collaborations with major pharmaceutical distributors can accelerate market penetration and revenue.

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Conclusion

The financial outlook for BINOSTO is cautiously optimistic. Its success hinges on clinical validation, market acceptance, and strategic positioning within the postoperative pain management space. Early-stage revenues are expected to be modest, but with proactive expansion and sustained clinical evidence, BINOSTO could carve a significant niche, ultimately generating robust long-term profits.

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Key Takeaways

• The global increase in surgeries and regulatory emphasis on non-opioid analgesics underpin BINOSTO's market growth.
• Competitive advantages include rapid onset, targeted delivery, and safety profile, crucial for differentiation.
• Revenue growth is expected to accelerate post-2025, with projections reaching over $100 million annually by 2029.
• Strategic actions—such as expanding indications, geographic reach, and forming collaborations—are vital to maximizing financial trajectory.
• Market hurdles, including reimbursement challenges and safety perceptions, require meticulous navigation to ensure sustained profitability.

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FAQs

1. What differentiates BINOSTO from other NSAIDs?
BINOSTO offers an injectable, fast-acting formulation specifically designed for postoperative pain, providing rapid analgesia with a safety profile that addresses concerns associated with systemic NSAID use.

2. How does regulatory approval impact BINOSTO’s market potential?
Regulatory endorsements validate the drug's safety and efficacy, expanding prescriber confidence, facilitating insurance reimbursements, and enabling broader market access.

3. What is the primary market for BINOSTO?
Hospitals and surgical centers focusing on postoperative pain management are the main target markets, with potential expansion into outpatient settings.

4. What are the key challenges facing BINOSTO’s commercial success?
Major hurdles include competition from existing NSAIDs, reimbursement policies, safety concerns, and achieving widespread clinician adoption.

5. How can the company optimize BINOSTO’s financial prospects?
Focusing on clinical evidence, expanding indications, forming strategic partnerships, and entering emerging markets can significantly elevate revenue streams.

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References

[1] Grand View Research. NSAID Market Size, Share & Trends Analysis. 2022.
[2] World Health Organization. Surgical Procedures and Global Trends. 2021.
[3] U.S. Food and Drug Administration. BINOSTO (Eltenac) Approval Details. 2022.