Dorzolamide hydrochloride; timolol maleate - Generic Drug Details

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

Dorzolamide hydrochloride; timolol maleate is the generic ingredient in three branded drugs marketed by Thea Pharma, Alembic, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Ingenus Pharms Llc, Micro Labs, Rubicon, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound.

Summary for dorzolamide hydrochloride; timolol maleate

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	21
Finished Product Suppliers / Packagers:	18
Clinical Trials:	9
DailyMed Link:	dorzolamide hydrochloride; timolol maleate at DailyMed

Recent Clinical Trials for dorzolamide hydrochloride; timolol maleate

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

Sponsor	Phase
University of Florida	Phase 1
Allergan	Phase 3
Allergan	Phase 4

See all dorzolamide hydrochloride; timolol maleate clinical trials

Pharmacology for dorzolamide hydrochloride; timolol maleate

Drug Class	Carbonic Anhydrase Inhibitor beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dorzolamide hydrochloride; timolol maleate

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COSOPT	Ophthalmic Solution	dorzolamide hydrochloride; timolol maleate	2%/0.5%	020869	1	2005-10-11

US Patents and Regulatory Information for dorzolamide hydrochloride; timolol maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215936-001	Jan 25, 2022	AT2	RX	No	No
Micro Labs	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	204777-001	May 28, 2020	AT1	RX	No	No
Bausch And Lomb	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	090037-001	Jul 14, 2009	AT1	RX	No	No
Zambon Spa	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	091180-001	Dec 4, 2013		DISCN	No	No
Ingenus Pharms Llc	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	217260-001	May 1, 2023	AT2	RX	No	No

Expired US Patents for dorzolamide hydrochloride; timolol maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	4,619,939*PED
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	6,316,443
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	6,248,735
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	4,797,413*PED

Dorzolamide hydrochloride; timolol maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Dorzolamide Hydrochloride and Timolol Maleate

Introduction

Dorzolamide hydrochloride and timolol maleate, commonly known by the brand name Cosopt, is a combination medication used to treat elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This article delves into the market dynamics and financial trajectory of this drug, highlighting its development, market presence, and financial implications.

Development and Approval

The combination of dorzolamide hydrochloride and timolol maleate was first approved by the FDA in 1998 under the brand name Cosopt. The original formulation contained a preservative, but a preservative-free version, Cosopt PF, was later approved in 2011 to cater to patients sensitive to preservatives[1].

Market Presence

Brand and Generic Versions

Cosopt, developed by Merck Sharp & Dohme Corp., was the first branded version of this combination therapy. Following the expiration of the original patent, several generic versions were approved. Hi-Tech Pharma was the first to submit an abbreviated new drug application (ANDA) for a generic version, which was approved in 2008. Other companies such as Sandoz, Bausch & Laumb, and Teva also received approvals for their generic versions[4].

Market Competition

The entry of generic competitors significantly altered the market dynamics. The presence of multiple generic versions led to increased competition, which typically results in lower prices and higher market penetration. This competition has been a key factor in the financial trajectory of dorzolamide hydrochloride and timolol maleate.

Financial Trajectory

Revenue Impact of Generic Competition

The approval of generic versions marked a significant shift in the revenue stream for Cosopt. Prior to the entry of generics, Merck enjoyed a monopoly on the market, leading to higher revenues. However, with the introduction of generic competitors, the revenue from Cosopt began to decline. Generic versions are generally priced lower, making them more accessible to a wider patient population but reducing the revenue per unit for the original brand[4].

Pricing Strategies

The pricing strategy for dorzolamide hydrochloride and timolol maleate has evolved over time. The branded version, Cosopt, was initially priced at a premium due to its innovative combination therapy and lack of competition. As generic versions entered the market, prices dropped significantly. For instance, the generic versions are often priced 50-70% lower than the branded version, making them more attractive to both patients and healthcare providers[4].

Clinical and Economic Benefits

Cost-Effectiveness

The combination therapy of dorzolamide hydrochloride and timolol maleate has been shown to be cost-effective compared to using the two medications separately. This is because it simplifies the treatment regimen, improving patient adherence and reducing the overall cost of treatment. Studies have demonstrated that the fixed-combination eye drops maintain the intraocular pressure (IOP) levels effectively, similar to concomitant administration of the individual drugs[3].

Patient Adherence

Patient adherence is a crucial factor in the financial trajectory of any medication. The fixed-combination therapy enhances adherence by reducing the number of drops patients need to administer daily. Improved adherence can lead to better health outcomes, which in turn can reduce the overall healthcare costs associated with managing glaucoma and ocular hypertension[3].

Adverse Reactions and Safety Profile

Systemic Absorption and Side Effects

While the combination therapy is generally well-tolerated, it can cause systemic side effects due to the absorption of timolol maleate. These include severe respiratory reactions, cardiac issues, and other systemic effects. The safety profile, although generally favorable, can impact the market dynamics by influencing prescribing decisions and patient compliance[5].

Regulatory and Legal Aspects

Market Exclusivity

The approval of generic versions was accompanied by legal disputes over market exclusivity. Hi-Tech Pharma and Apotex were involved in a controversy regarding the 180-day market exclusivity granted under the Hatch-Waxman Act. The FDA's decision to allow multiple generic versions to enter the market simultaneously further increased competition and reduced the financial advantages of being the first generic entrant[4].

Market Trends and Future Outlook

Growing Demand for Glaucoma Treatments

The global demand for glaucoma treatments is increasing due to the rising prevalence of the disease, particularly in aging populations. This trend is expected to drive the market for dorzolamide hydrochloride and timolol maleate, both in branded and generic forms.

Innovations in Formulations

Research into new formulations, such as viscous eye drops, is ongoing. These innovations aim to enhance the efficacy and patient comfort of the treatment. For instance, a study using a full factorial design to optimize the formulation of viscous eye drops for dorzolamide hydrochloride and timolol maleate showed promising results in terms of viscosity, mucoadhesion, and drug release[2].

Key Takeaways

• Market Competition: The entry of generic versions has significantly impacted the market dynamics, leading to lower prices and increased competition.
• Financial Trajectory: Revenue from the branded version has declined with the introduction of generics, while the overall market size has expanded due to increased accessibility.
• Clinical and Economic Benefits: The combination therapy is cost-effective and improves patient adherence.
• Regulatory and Legal Aspects: Legal disputes over market exclusivity have shaped the competitive landscape.
• Future Outlook: Growing demand for glaucoma treatments and innovations in formulations are expected to drive the market forward.

FAQs

What is the primary indication for dorzolamide hydrochloride and timolol maleate?

The primary indication is the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers alone[5].

How does the combination therapy compare to using the two medications separately?

The combination therapy maintains IOP levels effectively, similar to concomitant administration of the individual drugs, and simplifies the treatment regimen, improving patient adherence[3].

What are the common adverse reactions associated with dorzolamide hydrochloride and timolol maleate?

Common adverse reactions include stinging sensation, blurred vision, and systemic effects such as severe respiratory reactions and cardiac issues due to timolol maleate[5].

How has the introduction of generic versions affected the market?

The introduction of generic versions has led to increased competition, lower prices, and expanded market penetration, reducing the revenue from the branded version but increasing overall market size[4].

What are the ongoing innovations in the formulation of dorzolamide hydrochloride and timolol maleate?

Research is ongoing to develop new formulations, such as viscous eye drops, to enhance efficacy and patient comfort[2].

Sources

1. FDA Medical Review: NDA 202667 Cosopt PF (dorzolamide hydrochloride - timolol maleate ophthalmic solution)[1].
2. Science-Based Development: Full Factorial Design for Viscous Eye Drop of Dorzolamide Hydrochloride and Timolol Maleate[2].
3. Three-Month Evaluation: Ocular Hypotensive Effect and Safety of Dorzolamide Hydrochloride/Timolol Maleate Fixed-Combination Eye Drops[3].
4. Wikipedia: Dorzolamide/timolol[4].
5. DailyMed: Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution[5].