IOPIDINE Drug Patent Profile

Which patents cover Iopidine, and what generic alternatives are available?

Iopidine is a drug marketed by Harrow Eye and is included in two NDAs.

The generic ingredient in IOPIDINE is apraclonidine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apraclonidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iopidine

A generic version of IOPIDINE was approved as apraclonidine hydrochloride by RISING on March 12^th, 2009.

Summary for IOPIDINE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	472
Drug Prices:	Drug price information for IOPIDINE
What excipients (inactive ingredients) are in IOPIDINE?	IOPIDINE excipients list
DailyMed Link:	IOPIDINE at DailyMed

See drug prices for IOPIDINE

Recent Clinical Trials for IOPIDINE

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 4

See all IOPIDINE clinical trials

Pharmacology for IOPIDINE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

US Patents and Regulatory Information for IOPIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993	AT	RX	Yes	Yes
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987		RX	Yes	Yes

Expired US Patents for IOPIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987

International Patents for IOPIDINE

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	950008
Germany	3269242
Austria	18006
Japan	S58116417	METHOD OF LOWERING INTRAOCULAR PRESSURE

Supplementary Protection Certificates for IOPIDINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0081924	SPC/GB93/103	United Kingdom		SPC/GB93/103:, EXPIRES: 20071118

Market Dynamics and Financial Trajectory for IOPIDINE (Apraclonidine)

Last updated: July 27, 2025

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Introduction

IOPIDINE, commercially known as Apraclonidine, is a topical alpha-adrenergic receptor agonist primarily utilized in ophthalmology. Originally approved for decreasing intraocular pressure (IOP) in glaucoma patients, it also plays a crucial role in preventing postoperative intraocular pressure spikes and managing ocular hypertensive conditions. Understanding its market dynamics and financial trajectory involves analyzing clinical demand, competitive landscape, regulatory factors, and potential growth drivers.

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Pharmacological Profile and Clinical Applications

Apraclonidine functions by decreasing aqueous humor production, thereby reducing IOP — an essential factor in glaucoma management. Its quick onset and moderate efficacy position it as a preferred agent in specific contexts, including:

• Short-term management of elevated IOP
• Preoperative use to prevent IOP spikes
• Diagnostic procedures such as pharmacologic testing[1]

Because of its targeted usage, IOPIDINE's clinical applications remain relatively niche compared to broader glaucoma therapies but are nonetheless significant in acute care settings.

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Market Landscape and Competitive Environment

1. Primary Market Segments

• Ophthalmology Clinics: Prescriptions primarily originate within specialized ophthalmology and optometry clinics.
• Hospital Settings: Utilized during surgical procedures requiring precise IOP control.

2. Competitive Dynamics

While IOPIDINE's market is relatively stable, competition arises from:

• Beta-blockers (e.g., timolol): First-line treatments with broader indications.
• Prostaglandins (e.g., latanoprost): More effective for long-term IOP management.
• Alpha-adrenergic agents (e.g., brimonidine): Offer similar mechanisms with different profiles.
• Emerging Agents: New drugs with improved safety, efficacy, and delivery systems challenge IOPIDINE's market share.

3. Patent and Regulatory Status

IOPIDINE faced patent expirations in various jurisdictions, leading to increased generic availability. As a result, price competition and reduced barriers to entry have further stabilized its position as a cost-effective option for specific indications.

4. Geographic Markets

• North America & Europe: Mature markets, with stable demand, primarily for acute or perioperative use.
• Emerging Markets: Growing ophthalmic healthcare infrastructure presents opportunities for increased sales.

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Market Drivers and Restraints

1. Drivers

• Aging Population: Globally, the increasing elderly demographic escalates glaucoma prevalence ([2]).
• Surgical & Diagnostic Use: Steady need for intraoperative agents during ocular surgeries sustains demand.
• Cost-Effectiveness: Generic formulations make IOPIDINE a financially attractive option, especially in budget-constrained health systems.

2. Restraints

• Limited Long-Term Efficacy: Not suitable for chronic management; less appealing for long-term therapy.
• Safety Profile Concerns: Side effects such as drowsiness and systemic absorption risks limit broader use.
• Competition from Newer Agents: Longer-lasting, fewer side effects, and more patient-friendly formulations reduce reliance on IOPIDINE.

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Financial Trajectory and Revenue Outlook

1. Market Size and Revenue Trends

Current estimations suggest that IOPIDINE's global market size ranges between $100 million and $200 million annually, driven primarily by procedural and perioperative applications ([3]). The widespread availability of generics has led to price reductions, pressuring margins but expanding accessibility.

2. Growth Projections

• Moderate Growth (2–4% CAGR): Anticipated over the next five years, influenced by aging demographics and increasing surgical volumes.
• Impact of Patent Expirations: Further generic proliferation may suppress prices but could boost overall sales volume due to affordability.

3. Regional Variations

Emerging markets may experience higher growth rates as ophthalmic care infrastructure expands. Conversely, developed markets might see stagnation or slight decline due to competitive erosion and shift to newer therapies.

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Regulatory and Commercial Factors Influencing Financial Trajectory

• Regulatory Approvals: Variability across countries influences market access.
• Manufacturing & Supply Chain: Cost-efficient generic manufacturing could sustain profitability.
• Market Penetration Strategies: Educational campaigns emphasizing perioperative benefits can boost adoption.
• Partnerships & Licensing: Collaborations with local distributors expand reach, especially in emerging markets.

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Future Outlook & Strategic Considerations

The future of IOPIDINE hinges on its positioning within the broader ophthalmic therapeutics landscape. Despite challenges, it maintains niche utility in specific clinical scenarios. Companies with monetization strategies emphasizing procedural use, cost advantages, and strategic geographic expansion are poised to optimize its financial trajectory.

Innovation opportunities include developing combination formulations or alternative delivery systems that prolong its efficacy and reduce side effects—potentially rejuvenating interest and expanding its market. Additionally, regulatory incentives to repurpose existing drugs could catalyze new indications, further enhancing revenue streams.

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Key Takeaways

• IOPIDINE remains a valuable, cost-effective agent in ophthalmic care, especially for procedural and perioperative intraocular pressure management.
• Its market size is modest but stable, with sources estimating global revenue in the low hundreds of millions USD.
• Patent expirations and generic competition exert downward pressure on pricing but expand access.
• Growth drivers include demographic shifts and surgical procedure volumes; restraints involve competition from longer-acting agents and side effect profiles.
• Geographical expansion, strategic partnerships, and formulation innovations represent essential pathways to augment its financial performance.

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FAQs

1. What factors influence the prescribing patterns of IOPIDINE?
Physicians favor IOPIDINE for short-term, perioperative IOP control due to its quick onset and cost-effectiveness. However, its side effect profile and availability of newer agents influence its use.

2. How does patent expiration impact IOPIDINE's market?
Patent expiry enables generic manufacturers to produce affordable versions, increasing market penetration but reducing profit margins for branded formulations.

3. Are there emerging therapies likely to replace IOPIDINE?
Yes. Longer-acting prostaglandins and combination agents with better safety profiles are increasingly favored for chronic management, relegating IOPIDINE primarily to procedural uses.

4. What regional trends are anticipated in IOPIDINE’s market?
Emerging markets will see growth due to expanding healthcare access, while advanced economies may experience stable or declining demand owing to shifting preferences toward newer therapies.

5. Can innovation rejuvenate IOPIDINE’s market?
Potentially. Developing sustained-release formulations or combination drugs with reduced side effects could extend its relevance and market share.

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References

[1] Weinreb, R. N., & Khaw, P. T. (2004). Primary open-angle glaucoma. The Lancet, 363(9422), 1711-1720.
[2] Tham, Y. C., et al. (2014). Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology, 121(11), 2081-2090.
[3] MarketWatch. (2022). Global Ophthalmic Drugs Market Size, Share & Trends Analysis Report.

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