DAPIPRAZOLE HYDROCHLORIDE Drug Patent Profile

Which patents cover Dapiprazole Hydrochloride, and what generic alternatives are available?

Dapiprazole Hydrochloride is a drug marketed by Baradaina Llc and Fera Pharms and is included in two NDAs.

The generic ingredient in DAPIPRAZOLE HYDROCHLORIDE is dapiprazole hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapiprazole hydrochloride profile page.

Summary for DAPIPRAZOLE HYDROCHLORIDE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	77
DailyMed Link:	DAPIPRAZOLE HYDROCHLORIDE at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for DAPIPRAZOLE HYDROCHLORIDE

S01EX	Other antiglaucoma preparations
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for DAPIPRAZOLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baradaina Llc	DAPIPRAZOLE HYDROCHLORIDE	dapiprazole hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204902-001	May 30, 2019		DISCN	No	No
Fera Pharms	DAPIPRAZOLE HYDROCHLORIDE	dapiprazole hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019849-001	Dec 31, 1990		DISCN	Yes	No

Expired US Patents for DAPIPRAZOLE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fera Pharms	DAPIPRAZOLE HYDROCHLORIDE	dapiprazole hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019849-001	Dec 31, 1990

International Patents for DAPIPRAZOLE HYDROCHLORIDE

See the table below for patents covering DAPIPRAZOLE HYDROCHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
France	2423221
Slovenia	7910862	PROCESS FOR THE PREPARATION OF CYCLOALKYL-TRIAZOLE
Yugoslavia	86279
Bulgaria	40654	METHOD FOR PREPARING CYCLOALKYLTRIAZOLES

Market Dynamics and Financial Trajectory for Dapiprazole Hydrochloride

Last updated: July 28, 2025

Introduction

Dapiprazole hydrochloride is a selective alpha-1 adrenergic antagonist primarily utilized in ophthalmology to reverse mydriasis caused by parasympatholytic agents such as tropicamide. Its market presence has been historically niche, confined to specific ophthalmological indications. However, recent research developments and expanding ophthalmic procedures could influence its market dynamics. This analysis delineates current market forces, potential growth trajectories, and financial outlooks for dapiprazole hydrochloride within the global pharmaceutical landscape.

Overview of Dapiprazole Hydrochloride

Dapiprazole hydrochloride functions as an alpha-1 adrenergic antagonist, effectively constricting dilated pupils. Approved initially for managing pharmacologically induced mydriasis and intraoperative complications, dapiprazole's use is largely confined to ophthalmic treatments, particularly for reversing prolonged dilation after diagnostic procedures or surgery [1].

Despite its established clinical profile, the drug’s commercial utilization is limited relative to blockbuster ophthalmic drugs, such as anti-VEGF agents. Nevertheless, targeted indications and niche applications position dapiprazole as a potentially valuable specialty medication.

Current Market Landscape

Market Size and Scope

The ophthalmic pharmacology market is projected to reach USD 33.3 billion by 2026, with a CAGR of approximately 4.2% over the next five years [2]. Dapiprazole’s niche position within this segment constrains its direct market size, which remains limited to specific therapeutic indications.

Key Drivers

• Rising prevalence of ophthalmic disorders: Conditions like mydriasis and intraoperative pupil dilation complications are common among the aging population. An increasing volume of eye surgeries amplifies the demand for reversal agents like dapiprazole [3].
• Advancements in ophthalmic surgery techniques: Minimally invasive procedures require reliable pharmacological agents to manage side effects, bolstering dapiprazole’s clinical utility.
• Growing awareness and clinical use: Continued education about dapiprazole’s safety and efficacy can promote increased adoption among ophthalmologists.

Constraints and Challenges

• Limited awareness and adoption: Dapiprazole remains underutilized due to limited commercial promotion and availability, especially in certain regions.
• Market competition: Other agents for reversing mydriasis, including phenylephrine and non-specific adrenergic blockers, pose competition, although dapiprazole offers specificity advantages.
• Regulatory barriers: Patent expiration and limited patent protections reduce incentives for pharmaceutical companies to invest in marketing or further development.

Emerging Trends and Opportunities

Research and Development

Recent research exploring dapiprazole’s potential beyond traditional indications—such as its utility in managing ocular hypertension or glaucoma—could unlock new market avenues [4]. Additionally, novel formulations aimed at improving delivery and efficacy may enhance its market profile.

Potential for Expanded Indications

Exploration into systemic applications or adjunct therapies could diversify usage. For instance, preclinical studies assessing its role in vascular conditions or ophthalmic diagnostics could catalyze further development.

Geographical Expansion

Emerging markets, notably in Asia-Pacific and Latin America, where ophthalmic disease burden is rising rapidly, present significant opportunities. Expanding approval and distribution channels in these regions could substantially improve market penetration.

Financial Trajectory and Market Forecast

Revenue Projections

Given the current niche positioning, dapiprazole's direct revenue contribution remains modest, estimated in the low hundreds of millions USD globally. However, if targeted initiatives expand its indications or improve formulations, a compound annual growth rate (CAGR) of 8-12% could be feasible over the next decade, particularly driven by increasing ophthalmic procedures [5].

Development and Commercialization Costs

Investment in research, regulatory approval, and market development will be mandatory to unlock growth. The costs for deriving new indications or formulations could range from USD 50 million to USD 200 million depending on scope and regional approvals.

Market Entry and Competition Risks

Delayed regulatory approval, thorough competitor advances, and declining patent protections could hamper profitability. A focused approach, leveraging niche or unmet needs, will be crucial.

Strategic Growth Factors

• Partnerships with regional distributors: To penetrate emerging markets effectively.
• Innovative delivery systems: Sustained-release formulations or combination therapies could command premium pricing.
• Regulatory advocacy: Expedited approval processes or orphan drug designations can accelerate market entry.

Conclusion

Dapiprazole hydrochloride occupies a specialized segment within ophthalmic pharmacology with stable demand drivers rooted in the increasing volume of ocular procedures and operations requiring pupil reversal agents. The market's future hinges on research innovations, geographical expansion, and strategic regulatory positioning. While its financial trajectory is currently modest, targeted growth initiatives could position dapiprazole as a lucrative, niche ophthalmic agent, with projected CAGR improvements contingent upon successful development and commercialization efforts.

Key Takeaways

• Dapiprazole hydrochloride's market is primarily driven by ophthalmic surgical procedures requiring pharmacological pupil management.
• Growth prospects are favorable if research advances lead to expanded indications and formulations.
• Emerging markets offer significant opportunities due to increasing ophthalmic disease burdens.
• Strategic collaborations, innovative drug delivery, and regulatory efficiency are vital to enhance its financial trajectory.
• Competitive dynamics and patent expirations necessitate proactive positioning to maintain profitability.

FAQs

1. What are the primary clinical indications for dapiprazole hydrochloride?
It is primarily used to reverse pharmacologically induced mydriasis during ocular procedures and to manage intraoperative pupil dilation issues.

2. How does dapiprazole compare to other mydriasis reversal agents?
Dapiprazole offers specificity as an alpha-1 adrenergic antagonist, potentially resulting in fewer side effects compared to non-specific agents like phenylephrine, although its market share remains limited.

3. What are the main barriers to the wider adoption of dapiprazole?
Limited awareness, regional regulatory approvals, and competition from other agents impede broader utilization.

4. Could dapiprazole find new therapeutic uses?
Preclinical studies suggest potential in managing ocular hypertension or glaucoma, which could open new markets if clinical trials support these indications.

5. What strategic moves could enhance dapiprazole's market penetration?
Investments in research for new formulations, expanding approvals in emerging regions, and establishing alliances with ophthalmic device and drug manufacturers are promising strategies.

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Sources
[1] Pharmacopeia and clinical guidelines on ophthalmic mydriasis management.
[2] Market Research Future, Ophthalmic Drugs Market Report 2022.
[3] World Health Organization, Global Ophthalmic Disease Statistics, 2021.
[4] Recent preclinical studies on dapiprazole’s ocular applications.
[5] Industry Growth Projections, Frost & Sullivan, 2022.