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:	69
Patent Applications:	18
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	4,252,721

International Patents for DAPIPRAZOLE HYDROCHLORIDE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	156779
Austria	A305982
United Kingdom	2020269	CYCLOALKYLATRIAZOLES AND PROCESS FOR OBTAINING SAME
Denmark	148480

DAPIPRAZOLE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dapiprazole Hydrochloride

Introduction

Dapiprazole hydrochloride, known by its U.S. trade name Rev-Eyes, is an alpha-adrenergic blocking agent used in ophthalmic solutions to reverse mydriasis (pupil dilation) after eye examinations. To understand its market dynamics and financial trajectory, we need to delve into its usage, market presence, and the financial performance of the companies involved in its production and distribution.

Mechanism of Action and Clinical Use

Dapiprazole acts by blocking the alpha1-adrenergic receptors in smooth muscle, producing miosis (pupillary constriction) without affecting ciliary muscle contraction or intraocular pressure (IOP)[4].

Market Presence

Approval and Regulation

Dapiprazole hydrochloride is approved for use in various countries, including the United States. Its approval process typically involves submission to regulatory bodies like the FDA, which evaluates its safety and efficacy.

Competition

The ophthalmic market for mydriasis reversal agents is relatively niche but competitive. Dapiprazole competes with other agents, although it is one of the few specifically approved for this purpose. The competition is limited due to the specialized nature of the product.

Financial Performance of Related Companies

Revenue Streams

Companies involved in the production and distribution of dapiprazole hydrochloride generate revenue primarily through the sale of the ophthalmic solution. This revenue is part of the broader pharmaceutical segment, which can be influenced by factors such as market demand, competition, and regulatory changes.

Example: Angelini Industries

Angelini Industries, a company with a significant presence in the pharmaceutical sector, provides a relevant example. While they do not specifically mention dapiprazole in their reports, their overall financial performance in the pharmaceutical sector can give insights into the market dynamics.

• In 2021, Angelini Industries reported consolidated revenues of 1,725 million euros, with a slight increase from the previous year. The pharmaceutical segment, particularly Angelini Pharma, contributed significantly to this revenue[2].
• In 2022, the company saw double-digit growth in overall revenues, surpassing 2 billion euros for the first time, with EBITDA increasing by over 30% to 254 million euros[3].

Investment and Innovation

Companies like Angelini Industries are also investing in innovation and expansion, which can impact the financial trajectory of specific products like dapiprazole hydrochloride. For instance, the creation of Angelini Ventures, a venture capital arm focused on biotechnology, life science, and digital healthcare, indicates a long-term commitment to innovation and growth[3].

Market Dynamics

Demand and Supply

The demand for dapiprazole hydrochloride is driven by the need for mydriasis reversal in ophthalmic examinations. This demand is relatively stable but can be influenced by factors such as the frequency of eye examinations and the availability of alternative treatments.

Pricing and Accessibility

The pricing of dapiprazole hydrochloride can vary based on market conditions, competition, and regulatory environments. Accessibility is also a factor, with the drug being available in various regions through strategic alliances and distribution networks.

Regulatory Environment

Regulatory changes and compliance requirements can significantly impact the market dynamics of dapiprazole hydrochloride. For example, the FDA's approval process and any subsequent post-marketing requirements can affect the drug's availability and pricing[1].

Financial Trajectory

Revenue Growth

The revenue growth for dapiprazole hydrochloride is likely to be steady, driven by consistent demand in the ophthalmic sector. However, this growth can be influenced by broader market trends, competition, and regulatory changes.

Profit Margins

Profit margins for pharmaceutical companies producing dapiprazole hydrochloride can vary based on production costs, market pricing, and the efficiency of distribution networks. Companies like Angelini Industries, with diversified portfolios and strong distribution channels, tend to maintain healthier profit margins.

Future Outlook

The future outlook for dapiprazole hydrochloride is positive, given its specialized use and the ongoing need for mydriasis reversal agents. Investments in innovation and expansion by pharmaceutical companies will likely continue to support the financial trajectory of this drug.

Key Takeaways

• Mechanism and Use: Dapiprazole hydrochloride is an alpha-adrenergic blocking agent used to reverse mydriasis.
• Market Presence: It competes in a niche but competitive market for ophthalmic solutions.
• Financial Performance: Revenue is generated through sales, influenced by market demand, competition, and regulatory changes.
• Regulatory Environment: FDA approval and post-marketing requirements are crucial.
• Future Outlook: Steady revenue growth is expected, driven by consistent demand and supported by innovation and expansion in the pharmaceutical sector.

FAQs

What is dapiprazole hydrochloride used for?

Dapiprazole hydrochloride is used to reverse mydriasis (pupil dilation) after eye examinations.

How does dapiprazole hydrochloride work?

It works by blocking the alpha1-adrenergic receptors in smooth muscle, producing miosis (pupillary constriction) without affecting ciliary muscle contraction or intraocular pressure (IOP)[4].

Which companies are involved in the production and distribution of dapiprazole hydrochloride?

While specific companies are not detailed in the sources, pharmaceutical companies like Angelini Industries are involved in the broader ophthalmic and pharmaceutical markets.

What factors influence the demand for dapiprazole hydrochloride?

Demand is influenced by the frequency of eye examinations and the availability of alternative treatments.

How does the regulatory environment impact dapiprazole hydrochloride?

Regulatory changes and compliance requirements, such as FDA approval and post-marketing studies, can significantly affect the drug's availability and pricing[1].

Sources

1. FDA Summary Review for NDA 207926: Phenylephrine Hydrochloride Ophthalmic Solution.
2. Angelini Industries Sustainability Report 2021.
3. Angelini Industries Annual Report 2022.
4. DrugBank: Dapiprazole.