TRUSOPT Drug Patent Profile

When do Trusopt patents expire, and what generic alternatives are available?

Trusopt is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in TRUSOPT is dorzolamide hydrochloride. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trusopt

A generic version of TRUSOPT was approved as dorzolamide hydrochloride by RUBICON on October 28^th, 2008.

Summary for TRUSOPT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	12
Patent Applications:	4,829
Drug Prices:	Drug price information for TRUSOPT
What excipients (inactive ingredients) are in TRUSOPT?	TRUSOPT excipients list
DailyMed Link:	TRUSOPT at DailyMed

See drug prices for TRUSOPT

See drug sales revenues for TRUSOPT

Recent Clinical Trials for TRUSOPT

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

Sponsor	Phase
National Eye Institute (NEI)	Phase 3
University of Miami	Phase 3
National Eye Institute (NEI)	Phase 1/Phase 2

See all TRUSOPT clinical trials

Paragraph IV (Patent) Challenges for TRUSOPT

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 TRUSOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994		DISCN	Yes	No

Expired US Patents for TRUSOPT

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
Msd Sub Merck	TRUSOPT	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020408-001	Dec 9, 1994

International Patents for TRUSOPT

See the table below for patents covering TRUSOPT around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	88633
Japan	S61158978	SUBSTITUTED AROMATIC SULFONAMIDES AS ANTIGLAUCOMA
United Kingdom	2155331	COMPOSITION FOR REDUCING INTRAOCULAR PRESSURE
Canada	1193546	PROCESSUS POUR REDUIRE LA PRESSION INTRAOCULAIRE (PROCESS FOR REDUCING INTRAOCULAR PRESSURE)
Japan	S57500978
Germany	3568431
Mexico	9203485	DERIVADOS DE TIENO SULFONAMIDA, COMPOSICIONES FARMACEUTICAS Y USO.

Supplementary Protection Certificates for TRUSOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296879	96C0003	Belgium		PRODUCT NAME: HYDROCHLORIDUM, EQ. DORZOLAMIDUM; NAT. REGISTRATION NO/DATE: 922 IS 168 F13 19951019; FIRST REGISTRATION: SE 12208 19941219
0509752	SPC/GB99/043	United Kingdom		PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
0509752	C990041	Netherlands		PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306

TRUSOPT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dorzolamide Hydrochloride (TRUSOPT)

Introduction

Dorzolamide hydrochloride, marketed under the brand name TRUSOPT, is a crucial medication in the ophthalmic pharmaceutical market, primarily used for the treatment of glaucoma and ocular hypertension. This article delves into the market dynamics and financial trajectory of this drug, highlighting its growth, financial performance, competitive landscape, and future trends.

Market Growth and Trends

Increasing Awareness of Eye Health

The global market for dorzolamide hydrochloride is driven by a growing awareness of eye health issues. As more people become informed about the importance of eye care, the demand for effective treatments like TRUSOPT increases. This trend is expected to continue, contributing significantly to the market growth of dorzolamide hydrochloride[1].

Rising Incidence of Glaucoma

Glaucoma, a chronic and progressive eye condition, affects millions worldwide. The rising incidence of glaucoma, particularly in aging populations, is a key factor driving the demand for dorzolamide hydrochloride. This demographic shift ensures a steady and growing market for the drug[1].

Financial Performance

Prescription Volume

TRUSOPT 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 strong financial performance for the drug[1].

Generic Availability

Since its patent expiration, dorzolamide hydrochloride has become available as a generic medication. While generic competition has increased, it has also made the drug more accessible and affordable for a wider patient population. This has contributed to its sustained market presence and financial stability[1].

Revenue Streams

The revenue generated from TRUSOPT primarily comes from its use in treating glaucoma and ocular hypertension. The drug's effectiveness and lack of severe systemic side effects have made it a staple in ophthalmic care, ensuring a stable revenue stream. The drug's unique advantages, such as its topical administration, further enhance its market position[1].

Competitive Landscape

Market Competition

The ophthalmic pharmaceutical market is highly competitive, with several other medications available for treating glaucoma and ocular hypertension. However, TRUSOPT's unique advantages, such as its topical administration and lack of systemic side effects, help it maintain a significant market share. The drug's efficacy and safety profile, demonstrated through various clinical trials, also contribute to its competitive edge[1][4].

Innovations and Future Trends

The market for dorzolamide hydrochloride is 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. These innovations are expected to keep TRUSOPT relevant in the evolving ophthalmic care landscape[1].

Clinical Impact

Mechanism of Action

TRUSOPT is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. It works by inhibiting carbonic anhydrase in the ciliary processes of the eye, reducing aqueous humor secretion and subsequently lowering intraocular pressure (IOP)[4].

Efficacy

Clinical trials have demonstrated the efficacy of TRUSOPT in lowering IOP. In a one-year controlled trial, TRUSOPT showed significant reductions in IOP compared to other treatments like betaxolol and timolol. The drug's effectiveness as monotherapy and as an adjunct to beta-blockers has been consistently proven[4].

Safety Profile

TRUSOPT has a favorable safety profile, with the most frequently reported adverse events being burning and stinging sensations, and taste perversion. Unlike oral carbonic anhydrase inhibitors, TRUSOPT has minimal systemic exposure due to its topical administration, reducing the risk of systemic side effects[4].

Financial Projections

Continued Market Presence

Given the steady growth in demand driven by increasing awareness of eye health and the rising incidence of glaucoma, TRUSOPT is expected to remain a significant player in the ophthalmic pharmaceutical market. Its established efficacy and safety profile ensure its continued relevance[1].

Expanding Patient Base

As the global population ages, the incidence of glaucoma and ocular hypertension is expected to rise, expanding the patient base for TRUSOPT. This demographic shift will continue to drive the demand for the drug[1].

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. The generic availability has made the drug more accessible, which is expected to sustain its market presence[1].

Regulatory Status

TRUSOPT has a well-established approval status globally. It was approved by the FDA in 1994 and has since been widely used for the treatment of glaucoma and ocular hypertension. The drug's regulatory status is a testament to its safety and efficacy[1].

Future Trends

Ongoing Research and Development

The market for dorzolamide hydrochloride is also influenced by ongoing research and development in ophthalmic solutions. New formulations, combination therapies, and innovative delivery systems are being explored. These advancements could further enhance the drug's market position and financial trajectory[1].

Market Expansion

As healthcare systems around the world continue to evolve, there is potential for TRUSOPT to expand into new markets. Increasing access to healthcare in developing countries and growing awareness of eye health issues globally will likely drive further growth for the drug[1].

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 the primary use of TRUSOPT?

TRUSOPT is primarily used for the treatment of glaucoma and ocular hypertension by lowering intraocular pressure (IOP).

How does TRUSOPT work?

TRUSOPT works by inhibiting carbonic anhydrase in the ciliary processes of the eye, reducing aqueous humor secretion and subsequently lowering IOP[4].

What are the common side effects of TRUSOPT?

The most frequently reported adverse events associated with TRUSOPT are burning and stinging sensations, and taste perversion[4].

Is TRUSOPT available as a generic medication?

Yes, TRUSOPT is available as a generic medication since its patent expiration, making it more accessible and affordable for patients[1].

What is the outlook for TRUSOPT in the future market?

TRUSOPT is expected to remain a significant player in the ophthalmic pharmaceutical market due to its established efficacy, safety profile, and ongoing research and development in ophthalmic solutions[1].

Sources

1. DrugPatentWatch - Dorzolamide hydrochloride - Generic Drug Details
2. Santen Pharmaceutical - Summary of Year End Financial Results
3. econstor - Trajectories of prices in generic drug markets
4. E-lactancia - TRUSOPT® (dorzolamide hydrochloride)
5. Santen Pharmaceutical - Q2 Fiscal Year 2021 Report