Apraclonidine hydrochloride - Generic Drug Details

What are the generic drug sources for apraclonidine hydrochloride and what is the scope of freedom to operate?

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:	86
Clinical Trials:	3
Patent Applications:	629
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
University of Alabama at Birmingham	Phase 4
American University of Beirut Medical Center	Phase 2
Walter Reed Army Medical Center	N/A

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

Apraclonidine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Apraclonidine Hydrochloride

Introduction

Apraclonidine hydrochloride is a topical ophthalmic solution used primarily for the treatment of glaucoma and the reduction of intraocular pressure (IOP). Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The apraclonidine hydrochloride market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 650 million. Projections indicate that this market is expected to expand substantially, reaching nearly USD 1.1 billion by 2032[1].

Drivers of Market Growth

Several factors are driving the growth of the apraclonidine hydrochloride market:

Increasing Prevalence of Glaucoma

The rising incidence of glaucoma, a leading cause of irreversible blindness, is a major driver. As the global population ages, the demand for effective glaucoma treatments, including apraclonidine hydrochloride, is increasing[5].

Efficacy in Reducing IOP

Apraclonidine hydrochloride has been shown to be highly effective in reducing IOP, which is a critical factor in managing glaucoma. Studies have demonstrated that apraclonidine can lower IOP by 20-23% and suppress aqueous humor flow by 39-44%[2][5].

Adjunctive Therapy

The drug is often used as an adjunct to maximally tolerated medical therapy for patients who require additional IOP reduction. This niche application ensures a steady demand, particularly among patients who are at risk of undergoing surgery due to uncontrolled IOP[3][5].

Competitive Landscape

The market for apraclonidine hydrochloride is competitive, with other alpha-2 adrenergic agonists like brimonidine also available. However, apraclonidine has its unique advantages and is preferred in certain clinical scenarios.

Comparison with Brimonidine

Studies have shown that while both apraclonidine and brimonidine are effective in reducing IOP, there are no statistically significant differences between their effects on aqueous humor dynamics. However, apraclonidine's consensual effect on aqueous humor flow can be an additional benefit in some cases[2].

Regional Market Dynamics

The market for apraclonidine hydrochloride varies by region, influenced by factors such as healthcare infrastructure, regulatory environments, and patient demographics.

Customization of Market Reports

To gain a deeper understanding of regional dynamics, market reports can be customized to focus on specific regions or segments. This allows for a more targeted analysis of market trends and opportunities[1].

Financial Performance and Projections

The financial performance of the apraclonidine hydrochloride market is robust, with significant growth projected over the next decade.

Revenue Growth

The market is expected to grow from USD 650 million in 2023 to nearly USD 1.1 billion by 2032, indicating a compound annual growth rate (CAGR) that reflects the increasing demand for this medication[1].

Investment and Research

The optimistic trajectory of the market dynamics suggests that investments in research and development, as well as in marketing and distribution, are likely to yield positive returns. Companies are investing in high-quality reports and customized research to better understand and capitalize on market opportunities[1][4].

Challenges and Limitations

Despite the positive outlook, there are challenges and limitations associated with apraclonidine hydrochloride:

Side Effects and Tachyphylaxis

The drug can cause side effects such as conjunctival hyperemia and dry mouth. Additionally, there is a risk of tachyphylaxis, where the efficacy of the drug diminishes over time in some patients. These factors can limit its long-term utility and require close monitoring[5].

Systemic Absorption

Apraclonidine hydrochloride is systemically absorbed, which can lead to systemic side effects, particularly in patients with impaired renal function. Close monitoring of cardiovascular parameters is advised in such cases[5].

Regulatory and Safety Considerations

The use of apraclonidine hydrochloride is subject to regulatory oversight, and safety considerations are paramount.

Clinical Trials and Approval

The drug has undergone rigorous clinical trials to establish its safety and efficacy. It is indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction[5].

Mutagenicity and Carcinogenicity

Studies have shown that apraclonidine hydrochloride is not mutagenic and does not significantly affect tumor incidence or fertility in animal models[5].

Conclusion

The market for apraclonidine hydrochloride is poised for significant growth, driven by its efficacy in reducing IOP and its role as an adjunctive therapy in glaucoma management. While there are challenges related to side effects and systemic absorption, the overall financial trajectory is positive. As the global healthcare landscape continues to evolve, the demand for effective glaucoma treatments like apraclonidine hydrochloride is expected to remain strong.

Key Takeaways

• The apraclonidine hydrochloride market is projected to grow from USD 650 million in 2023 to nearly USD 1.1 billion by 2032.
• The drug is highly effective in reducing IOP and is used as an adjunct to maximally tolerated medical therapy.
• Regional market dynamics vary, and customized market reports can provide targeted insights.
• Side effects and tachyphylaxis are potential limitations that require close monitoring.
• Regulatory and safety considerations are crucial, with the drug undergoing rigorous clinical trials.

FAQs

Q: What is the primary use of apraclonidine hydrochloride?

A: Apraclonidine hydrochloride is primarily used for the reduction of intraocular pressure (IOP) in patients with glaucoma.

Q: How effective is apraclonidine hydrochloride in reducing IOP?

A: Apraclonidine hydrochloride can lower IOP by 20-23% and suppress aqueous humor flow by 39-44%[2][5].

Q: What are the common side effects of apraclonidine hydrochloride?

A: Common side effects include conjunctival hyperemia and dry mouth. Systemic side effects can also occur due to systemic absorption[5].

Q: Is apraclonidine hydrochloride mutagenic or carcinogenic?

A: No, apraclonidine hydrochloride has not been found to be mutagenic or carcinogenic in animal studies[5].

Q: What is the projected market size of apraclonidine hydrochloride by 2032?

A: The market is projected to reach nearly USD 1.1 billion by 2032[1].

Sources

1. DataIntelo: Apraclonidine Hydrochloride Market Research Report 2032.
2. JAMA Network: Comparison of the Efficacy of Apraclonidine and Brimonidine as Acute Aqueous Suppressing Agents.
3. PubMed: Short-term efficacy of apraclonidine hydrochloride added to maximally tolerated medical therapy for glaucoma.
4. Market Research Intellect: Global Apraclonidine Hydrochloride Market Size, Trends and Forecast.
5. DailyMed: Apraclonidine Hydrochloride Solution/Drops.