DORZOLAMIDE HYDROCHLORIDE - Generic Drug Details

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

Dorzolamide hydrochloride is the generic ingredient in five branded drugs marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Msd Sub Merck, Thea Pharma, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for dorzolamide hydrochloride. Twelve suppliers are listed for this compound.

Summary for DORZOLAMIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	19
NDAs:	35
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	56
Patent Applications:	587
What excipients (inactive ingredients) are in DORZOLAMIDE HYDROCHLORIDE?	DORZOLAMIDE HYDROCHLORIDE excipients list
DailyMed Link:	DORZOLAMIDE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DORZOLAMIDE HYDROCHLORIDE

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

Sponsor	Phase
Laboratorios Poen	Phase 4
Shahid Beheshti University of Medical Sciences	Phase 2/Phase 3
Salus University	Phase 4

See all DORZOLAMIDE HYDROCHLORIDE clinical trials

Pharmacology for DORZOLAMIDE HYDROCHLORIDE

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DORZOLAMIDE HYDROCHLORIDE

S01EC	Carbonic anhydrase inhibitors
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUSOPT	Ophthalmic Solution	dorzolamide hydrochloride	2%	020408	1	2005-10-11

US Patents and Regulatory Information for DORZOLAMIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	AT1	RX	Yes	Yes
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994		DISCN	Yes	No
Fdc Ltd	DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	205294-001	Jan 24, 2019	AT	RX	No	No

Expired US Patents for DORZOLAMIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994	4,619,939*PED
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994	4,797,413*PED

DORZOLAMIDE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dorzolamide Hydrochloride

Introduction

Dorzolamide hydrochloride, marketed under the brand name Trusopt among others, is a significant medication in the ophthalmic pharmaceutical market, particularly for the treatment of glaucoma and ocular hypertension. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Growth and Trends

The market for dorzolamide hydrochloride is experiencing steady growth, driven by several key factors:

Increasing Awareness of Eye Health

There is a growing awareness of eye health issues globally, which has led to an increased demand for effective treatments for glaucoma and ocular hypertension. This trend is expected to continue, driving the market growth for dorzolamide hydrochloride[3].

Rising Incidence of Glaucoma

Glaucoma is a chronic and progressive eye condition that affects millions worldwide. The rising incidence of glaucoma, particularly in aging populations, contributes significantly to the demand for dorzolamide hydrochloride[3].

Advantages Over Other Treatments

Dorzolamide hydrochloride offers several advantages over other treatments, such as beta-adrenergic antagonists. It does not cause miosis, does not interfere with vision as much as other medications like pilocarpine or epinephrine, and is not contraindicated in patients with asthma, reactive airways disease, or heart disease. These benefits make it a preferred option for many patients, further boosting its market[4].

Financial Performance

Prescription Volume

Dorzolamide hydrochloride has been a consistently prescribed medication. In 2022, it was the 201st most commonly prescribed medication in the United States, with over 2 million prescriptions. This high prescription volume indicates a strong financial performance for the drug[5].

Generic Availability

Since its patent expiration, dorzolamide hydrochloride has become available as a generic medication. While this has increased competition, it has also made the drug more accessible and affordable for a wider patient population, contributing to its sustained market presence[5].

Revenue Streams

The revenue generated from dorzolamide hydrochloride comes primarily from its use in treating glaucoma and ocular hypertension. The drug's effectiveness and the lack of severe systemic side effects have made it a staple in ophthalmic care, ensuring a stable revenue stream.

Clinical and Therapeutic Impact

Efficacy in Clinical Studies

Clinical studies have consistently shown that dorzolamide hydrochloride is effective in lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP-lowering effect of dorzolamide hydrochloride is approximately 3 to 5 mmHg throughout the day, making it a reliable treatment option[2][4].

Combination Therapy

Dorzolamide hydrochloride is often used in combination with other ophthalmic medications, such as beta-adrenergic antagonists, to enhance its therapeutic effects. This combination therapy further expands its market reach and financial potential[4].

Regulatory and Approval Status

Initial Approval and Global Availability

Dorzolamide hydrochloride was first approved in the United States and New Zealand in December 1994. Since then, it has been approved and is available in many countries worldwide, contributing to its global market presence[1].

Safety and Efficacy Profile

The drug has a well-established safety and efficacy profile, with common side effects including eye discomfort, eye redness, taste changes, and blurry vision. Serious side effects are rare, which has helped in maintaining its approval status and market acceptance[5].

Competitive Landscape

Market Competition

The ophthalmic pharmaceutical market is competitive, with several other medications available for treating glaucoma and ocular hypertension. However, dorzolamide hydrochloride's unique advantages, such as its topical administration and lack of systemic side effects, help it maintain a significant market share[4].

Innovations and Future Trends

The market for dorzolamide hydrochloride is also influenced by ongoing research and development in ophthalmic solutions. New formulations and combination therapies are being explored, which could further enhance the drug's market position and financial trajectory[3].

Financial Projections

Given the steady growth in the demand for dorzolamide hydrochloride, driven by increasing awareness of eye health and the rising incidence of glaucoma, the financial projections for this drug are positive. Here are some key points:

Continued Market Presence

Dorzolamide hydrochloride is expected to remain a significant player in the ophthalmic pharmaceutical market due to its established efficacy and safety profile.

Expanding Patient Base

As the global population ages, the incidence of glaucoma and ocular hypertension is expected to rise, expanding the patient base for dorzolamide hydrochloride.

Generic Competition

While generic competition may affect the revenue from branded versions, the overall demand for dorzolamide hydrochloride is likely to remain strong due to its therapeutic benefits.

Key Takeaways

• Market Growth: Driven by increasing awareness of eye health and the rising incidence of glaucoma.
• Financial Performance: Strong prescription volume and revenue streams.
• Clinical Impact: Effective in lowering IOP with a favorable safety profile.
• Regulatory Status: Well-established approval status globally.
• Competitive Landscape: Unique advantages over other treatments maintain its market share.
• Future Trends: Ongoing R&D in ophthalmic solutions to enhance its market position.

FAQs

What is dorzolamide hydrochloride used for?

Dorzolamide hydrochloride is used to treat high pressure inside the eye, specifically for conditions like glaucoma and ocular hypertension.

How does dorzolamide hydrochloride work?

It works by inhibiting the carbonic anhydrase enzyme, which reduces the production of aqueous humor and thereby lowers intraocular pressure.

What are the common side effects of dorzolamide hydrochloride?

Common side effects include eye discomfort, eye redness, taste changes, and blurry vision.

Can dorzolamide hydrochloride be used in combination with other medications?

Yes, it is often used in combination with other ophthalmic medications to enhance its therapeutic effects.

Is dorzolamide hydrochloride available as a generic medication?

Yes, dorzolamide hydrochloride is available as a generic medication, making it more accessible and affordable for patients.

Sources

1. Patsnap Synapse: Dorzolamide Hydrochloride Unveiled: A Detailed Overview of its Revolutionary R&D Breakthroughs.
2. FDA: TRUSOPT (dorzolamide hydrochloride) Ophthalmic Solution.
3. Market Research Intellect: Dorzolamide Hydrochloride: Key Trends Driving the Future of Ophthalmic Solutions.
4. PubMed: Dorzolamide. A review of its pharmacology and therapeutic potential.
5. Wikipedia: Dorzolamide.