Timolol maleate - Generic Drug Details

What are the generic drug sources for timolol maleate and what is the scope of freedom to operate?

Timolol maleate is the generic ingredient in six branded drugs marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Bausch And Lomb Inc, Bausch And Lomb, Amring Pharms, Apotex, Apotex Inc, Caplin, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Somerset, Merck, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for timolol maleate. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for timolol maleate

US Patents:	0
Tradenames:	6
Applicants:	33
NDAs:	59
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	69
Patent Applications:	6,505
Drug Prices:	Drug price trends for timolol maleate
What excipients (inactive ingredients) are in timolol maleate?	timolol maleate excipients list
DailyMed Link:	timolol maleate at DailyMed

See drug prices for timolol maleate

See drug sales revenues for timolol maleate

Recent Clinical Trials for timolol maleate

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

Sponsor	Phase
SpyGlass Pharma, Inc.	Phase 1/Phase 2
D. Western Therapeutics Institute, Inc.	Phase 2
Qlaris Bio, Inc.	Phase 2

See all timolol maleate clinical trials

Generic filers with tentative approvals for TIMOLOL MALEATE

Applicant	Application No.	Strength	Dosage Form
		0.5%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for timolol maleate

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for timolol maleate

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

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

Paragraph IV (Patent) Challenges for TIMOLOL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISTALOL	Ophthalmic Solution	timolol maleate	0.5%	021516	1	2012-10-19

US Patents and Regulatory Information for timolol maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-001	Oct 21, 1998	AB	RX	Yes	Yes
Somerset Theraps Llc	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	216653-001	Jul 3, 2024	AT2	RX	No	No
Usl Pharma	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072003-001	Apr 11, 1989		DISCN	No	No
Epic Pharma Llc	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	074515-001	Mar 25, 1997		DISCN	No	No
Watson Labs	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072271-001	Apr 11, 1989		DISCN	No	No
Apotex Inc	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	075412-001	Sep 8, 2000		DISCN	No	No

Expired US Patents for timolol maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	6,335,335
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-002	Approved Prior to Jan 1, 1982	3,655,663
Bausch And Lomb Inc	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	4,195,085
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-001	Oct 21, 1998	6,174,524*PED
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982	3,655,663
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982	4,195,085

Timolol maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Timolol Maleate

Introduction to Timolol Maleate

Timolol maleate is a beta-blocker used in the treatment of increased intraocular pressure associated with open-angle glaucoma. It is administered as an ophthalmic solution and can be used alone or in combination with other antiglaucoma medications.

Market Size and Growth Projections

The market for timolol maleate eye drops is experiencing robust growth, driven by several key factors. As of 2023, the global glaucoma eye drops market, which includes timolol maleate, is valued at approximately US$ 1,666.3 million and is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.3% from 2023 to 2030, reaching an estimated value of US$ 2,725.4 million by 2030[4].

Segmentation and Market Analysis

The timolol maleate eye drop market is segmented based on type, application, and geographical regions.

Type Segmentation

The market is categorized into different volumes, such as 5mL and 10mL. This segmentation helps in understanding the demand for different product formats and their respective market shares[1].

Application Segmentation

The primary applications include hospitals, ophthalmic clinics, pharmacies, and other healthcare settings. The demand from these segments is driven by the prevalence of glaucoma and the need for effective treatment options[1].

Geographical Segmentation

The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America is expected to dominate the market due to increased research and development activities in the region[4].

Drivers of Market Growth

Several factors are driving the growth of the timolol maleate market:

Increasing Product Launches

New product launches by key market players are a significant driver. For example, the launch of brimonidine tartrate and timolol maleate ophthalmic solution by Upsher-Smith Laboratories, LLC, has contributed to market growth[4].

Mergers, Acquisitions, and Partnerships

The increasing number of mergers, acquisitions, and partnerships in the ophthalmic pharmaceutical sector is also boosting market growth. For instance, the business combination between Oculis and European Biotech Acquisition Corp aims to drive innovations in ophthalmology[4].

Regulatory Approvals

Approvals by drug regulatory agencies, such as the FDA, for new glaucoma treatments provide lucrative opportunities for market expansion. The acceptance of new drug applications, like the one for PDP-716 by Visiox Pharma, is a positive indicator[4].

Challenges and Restraints

Despite the growth, the market faces several challenges:

COVID-19 Impact

The COVID-19 pandemic had a negative impact on the global glaucoma eye drops market, including timolol maleate. Nationwide lockdowns and the discontinuation of non-urgent care by ophthalmologists affected production and demand[4].

Market Competition

The market is highly competitive, with several established and emerging players. Companies like Novartis AG, Mylan, and Santen UK Limited are key competitors, and the market dynamics are influenced by their strategies and product offerings[1].

Financial Performance and Trends

Revenue Growth

The timolol maleate eye drop market is expected to see sustained revenue growth from 2023 to 2031. The positive momentum in market dynamics and the expected expansion indicate robust growth rates throughout the forecast period[1].

Cost and Pricing Analysis

The financial performance of companies in this market is influenced by factors such as cost of goods sold (COGS), selling, general, and administrative (SG&A) expenses, and research and development (R&D) expenses. For example, Santen Pharmaceutical Co., Ltd. reported a significant improvement in core operating profit due to strong sales and cost optimization in Q1 FY2023[2].

Regional Performance

The market performance varies by region. For instance, Santen Pharmaceutical saw strong growth in Asia and EMEA, driven by the recovery from COVID-19 and the sales momentum of new products like Rocklatan[2].

Company Profiles and Market Strategies

Key players in the timolol maleate market include:

• Novartis AG
• AdvaCare
• Aspire Pharma Ltd
• Mylan
• Santen UK Limited
• Martindale Pharma

These companies are profiled based on their product offerings, market entry year, and other market-related factors. Their strategies, such as product launches, mergers, and cost optimization, play a crucial role in shaping the market landscape[1].

Clinical Efficacy and Safety

Timolol maleate has been shown to be effective and well-tolerated when used alone or in combination with other antiglaucoma medications. Studies have demonstrated significant reductions in intraocular pressure without clinically significant ocular irritation or changes in visual acuity[3].

Key Takeaways

• The timolol maleate eye drop market is projected to grow significantly from 2023 to 2031, driven by new product launches and regulatory approvals.
• The market is segmented by type, application, and geographical regions, with North America expected to dominate.
• Challenges such as the COVID-19 pandemic and market competition need to be addressed.
• Key players are focusing on cost optimization and strategic partnerships to enhance their market position.
• Timolol maleate has proven clinical efficacy and safety, making it a preferred treatment option for open-angle glaucoma.

FAQs

Q: What is the current market size of the timolol maleate eye drop market? A: The global glaucoma eye drops market, which includes timolol maleate, is valued at approximately US$ 1,666.3 million as of 2023[4].

Q: What is the projected growth rate of the timolol maleate market? A: The market is expected to grow at a CAGR of 7.3% from 2023 to 2030[4].

Q: Which regions are expected to dominate the timolol maleate market? A: North America is expected to dominate the market due to increased R&D activities in the region[4].

Q: What are the key drivers of the timolol maleate market? A: Key drivers include increasing product launches, mergers and acquisitions, and regulatory approvals[4].

Q: How has the COVID-19 pandemic affected the timolol maleate market? A: The pandemic had a negative impact on the market due to disruptions in production and demand, as well as the discontinuation of non-urgent care by ophthalmologists[4].

Cited Sources

1. Market Research Intellect - Timolol Maleate Eye Drop Market Size, Scope And Forecast Report[1]
2. Santen Pharmaceutical - Q1 FY2023 Financial Results[2]
3. PubMed - Evaluation of timolol maleate combination therapy in chronic open-angle glaucoma[3]
4. Coherent Market Insights - Glaucoma Eye Drops Market Size, Trends And Forecast To 2030[4]