APRACLONIDINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for apraclonidine hydrochloride and what is the scope of patent protection?

Apraclonidine hydrochloride is the generic ingredient in two branded drugs marketed by Rising and Harrow Eye, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for apraclonidine hydrochloride. Two suppliers are listed for this compound.

Summary for APRACLONIDINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	4
Patent Applications:	728
What excipients (inactive ingredients) are in APRACLONIDINE HYDROCHLORIDE?	APRACLONIDINE HYDROCHLORIDE excipients list
DailyMed Link:	APRACLONIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for APRACLONIDINE HYDROCHLORIDE

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

Sponsor	Phase
Alcon Research	PHASE3
University of Alabama at Birmingham	Phase 4
American University of Beirut Medical Center	Phase 2

See all APRACLONIDINE HYDROCHLORIDE clinical trials

Pharmacology for APRACLONIDINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for APRACLONIDINE HYDROCHLORIDE

C02AC	Imidazoline receptor agonists
C02A	ANTIADRENERGIC AGENTS, CENTRALLY ACTING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

N02CX	Other antimigraine preparations
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for APRACLONIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	APRACLONIDINE HYDROCHLORIDE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	077764-001	Mar 12, 2009	AT	RX	No	No
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987		RX	Yes	Yes
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993	AT	RX	Yes	Yes

Expired US Patents for APRACLONIDINE HYDROCHLORIDE

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	4,517,199
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987	5,212,196
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987	4,517,199

Market Dynamics and Financial Trajectory for APRACLONIDINE HYDROCHLORIDE

Last updated: July 27, 2025

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Introduction

Apraclonidine Hydrochloride, marketed notably under brand names such as Iopidine, is a sympathomimetic agent primarily prescribed for the management of glaucoma and ocular hypertension. Its unique mechanism of stimulating alpha-adrenergic receptors makes it an essential component in ophthalmological therapeutics. This analysis explores the current market dynamics, potential growth drivers, competitive landscape, and the financial trajectory of Apraclonidine Hydrochloride within the ophthalmic pharmaceutical sector.

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Market Overview

The global ophthalmic pharmaceuticals market is projected to expand significantly in the coming years, driven by increasing prevalence of eye disorders such as glaucoma, age-related macular degeneration, and diabetic retinopathy. Glaucoma alone affects over 76 million people worldwide and is expected to reach 112 million by 2040, highlighting a substantial demand for effective intraocular pressure (IOP) lowering agents like Apraclonidine Hydrochloride [1].

Apraclonidine's role as an adjunct therapy for prevention of post-operative IOP spikes and its use in diagnostic procedures underpin its clinical importance. Despite competition from numerous drug classes such as prostaglandin analogs, beta-blockers, and combination therapies, Apraclonidine maintains a niche due to its unique pharmacodynamics and safety profile.

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Market Dynamics

Key Drivers

• Rising Glaucoma Incidence: The increasing global prevalence of glaucoma directly propels demand for medications like Apraclonidine. Aging populations in North America, Europe, and Asia-Pacific regions serve as critical markets.

• Expanding Ophthalmic Healthcare Access: Growth in healthcare infrastructure, especially in emerging economies, expands the treatment landscape for glaucoma patients, creating new opportunities for Apraclonidine sales.

• Off-label and Adjunct Use: Clinical practices increasingly adopt Apraclonidine preoperatively to prevent IOP spikes during laser surgeries and ocular procedures, broadening utilization scenarios.

• Patent Expiry and Generics: Patent expiration in multiple regions has led to a proliferation of generic versions, fueling affordability and wider access.

Challenges

• Limited Competitive Differentiation: Apraclonidine's therapeutic niche is narrow, facing stiff competition from more modern agents with longer duration or better tolerability.

• Adverse Effect Profile: Central nervous system side effects, allergic reactions, and rebound IOP rise with discontinuation may hinder prescribing trends.

• Regulatory Hurdles: Stringent approval pathways in different jurisdictions, coupled with off-label use constraints, pose barriers to market expansion.

Emerging Trends

• Combination Formulations: Companies are exploring fixed-dose combinations involving Apraclonidine to improve adherence and efficacy.

• Biotech Innovations: Advances in drug delivery systems, including sustained-release implants and nanoparticle-based formulations, may reshape the therapeutic landscape.

• Market Entry of Biosimilars: Although limited for small molecules like Apraclonidine, biosimilar development could influence pricing and accessibility.

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Financial Trajectory

Revenue Projections

From a pricing perspective, Apraclonidine Hydrochloride remains a relatively affordable medication attributed largely to generic availability. The revenue trajectory is expected to follow global ophthalmic drug market trends, with projections indicating modest growth rates (approximately 3-5% annually) over the next 5 years [2].

Emerging markets are anticipated to present higher growth potential, fueled by increasing healthcare investments and the rising burden of ocular diseases. However, major-developed markets may experience plateau effects due to existing market saturation and competition.

Impact of Patent and Market Entry

Patent expirations in key markets have led to a sharp price decrease for Apraclonidine formulations, diminishing profit margins for original developers. However, new formulations and combination products could offset revenue declines by capturing niche segments.

Investment and R&D

Pharmaceutical companies are investing selectively in ophthalmic drug development. R&D focus shifts toward improving drug delivery, reducing side effects, and expanding therapeutic indications, which may influence the financial outlook for Apraclonidine-related products.

Regulatory and Market Risks

Stringent approval pathways, especially regarding new formulations or indications, could delay revenue growth. Additionally, regulatory scrutiny and adverse event reports could impact sales volumes and pricing strategies.

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Competitive Landscape

Major players include Alcon, Bausch + Lomb, and Santen Pharmaceutical, holding significant market share for ophthalmic agents. The generic segment intensifies price competition, while R&D efforts aim at developing superior alternatives with improved efficacy or safety.

Emerging entrants are exploring innovative delivery mechanisms and combination therapies, possibly challenging the dominance of traditional Apraclonidine formulations.

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Conclusion and Future Outlook

The financial trajectory of Apraclonidine Hydrochloride hinges on a confluence of factors: demographic shifts, technological advancements, regulatory policies, and competitive dynamics. While the drug maintains relevance within its specified niche, long-term growth prospects depend on strategic innovation, expanding access in emerging markets, and lifecycle management through new formulations and combination products.

Given the current landscape, pharmaceutical companies should monitor regional regulatory developments and embrace formulation innovations to sustain profitability. Investors and stakeholders must approach with a nuanced understanding of the drug's position within ophthalmic therapeutics.

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Key Takeaways

• Market growth is driven by increasing glaucoma prevalence and expanding ophthalmic healthcare worldwide.
• Patent expirations have shifted revenue streams toward generics, reducing profit margins but increasing accessibility.
• Innovation in drug delivery and combination therapies is crucial for maintaining competitiveness and revenue growth.
• Emerging markets present significant opportunities for expansion, driven by rising healthcare infrastructure and patient awareness.
• Regulatory, safety, and efficacy considerations will shape the future adoption and financial performance of Apraclonidine Hydrochloride.

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FAQs

Q1: What are the primary therapeutic uses of Apraclonidine Hydrochloride?
A1: Apraclonidine Hydrochloride is mainly used to reduce intraocular pressure in glaucoma patients and for prophylactic management during ocular surgeries to prevent IOP spikes.

Q2: How does patent expiration impact the market for Apraclonidine?
A2: Patent expiration typically leads to generic competition, reducing prices and profit margins but increasing accessibility for patients.

Q3: What are the main challenges facing Apraclonidine's market growth?
A3: Challenges include competition from newer agents with better tolerability, limited differentiation, adverse side effects, and regulatory hurdles.

Q4: Are there ongoing innovations in Apraclonidine formulations?
A4: Yes, research is ongoing in developing combination drugs, sustained-release formulations, and delivery systems to enhance efficacy and compliance.

Q5: What is the outlook for Apraclonidine in emerging markets?
A5: The outlook remains positive due to rising glaucoma prevalence and expanding healthcare access, making emerging markets promising for growth despite price competition.

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References

[1] World Health Organization. "Prevalence of Glaucoma." 2021.
[2] MarketsandMarkets. "Ophthalmic Drugs Market by Product, Application, and Region." 2022.