TIMOLOL - Generic Drug Details

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

Timolol is the generic ingredient in eight branded drugs marketed by Thea Pharma, Epic Pharma Llc, Somerset, 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, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Merck, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in sixty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for timolol. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for TIMOLOL

US Patents:	0
Tradenames:	8
Applicants:	34
NDAs:	62
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	243
Patent Applications:	7,814
Drug Prices:	Drug price trends for TIMOLOL
Drug Sales Revenues:	Drug sales revenues for TIMOLOL
What excipients (inactive ingredients) are in TIMOLOL?	TIMOLOL excipients list
DailyMed Link:	TIMOLOL at DailyMed

See drug prices for TIMOLOL

See drug sales revenues for TIMOLOL

Recent Clinical Trials for TIMOLOL

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

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

See all TIMOLOL clinical trials

Generic filers with tentative approvals for TIMOLOL

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

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

Medical Subject Heading (MeSH) Categories for TIMOLOL

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for TIMOLOL

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

US Patents and Regulatory Information for TIMOLOL

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
Quantum Pharmics	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072466-001	May 19, 1989		DISCN	No	No
Chartwell Rx	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072550-001	Apr 13, 1989		DISCN	No	No
Mylan	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072668-003	Jun 8, 1990	AB	RX	No	No
Gland Pharma Ltd	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	214645-002	Feb 14, 2023	AB	RX	No	No

Expired US Patents for TIMOLOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-001	Mar 31, 1995
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-002	Mar 31, 1995

TIMOLOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Timolol Maleate

Introduction to Timolol Maleate

Timolol maleate is a non-selective beta-blocker commonly used in the treatment of glaucoma, ocular hypertension, and other eye conditions. It is available in various formulations, including eye drops and oral tablets.

Global Market Overview

The global market for ophthalmic drugs, which includes timolol maleate, is experiencing significant growth. Here are some key points that shape the market dynamics:

• Market Size and Growth: The global ophthalmic drugs market was estimated at USD 37.82 billion in 2023 and is projected to grow at a CAGR of 8.34% from 2024 to 2030[1].
• Segmentation: The market is segmented by drug class, disease, route of administration, and region. Timolol maleate falls under the category of beta-blockers, which are widely used for glaucoma treatment.

Timolol Maleate Market Specifics

Market Share and Demand Forecast

• The global market for timolol maleate eye drops, while not as large as other segments like anti-VEGF agents, still holds a significant share. The demand for timolol maleate is forecasted to grow, driven by the increasing prevalence of glaucoma and ocular hypertension[4].

Pricing Dynamics

• The cost of timolol maleate, like many other generic drugs, is relatively low compared to branded drugs. However, pricing can be volatile. For instance, the price of glaucoma drugs, including those similar to timolol maleate, has seen significant increases in the past due to low competition and regulatory backlogs[5].

Competition and Generic Impact

• The generic drugs segment, which includes timolol maleate, is projected to witness the fastest growth rate over the forecast period. This is due to the cost-effectiveness and patent expiry of branded drugs, making generics more attractive, especially in developing economies[1].

Regional Market Analysis

North America

• North America dominates the ophthalmic drugs market, including timolol maleate, due to the high prevalence of retinal diseases and favorable government initiatives. The region's high healthcare expenditure and the presence of regulatory entities also support market growth[1].

Asia Pacific

• The Asia Pacific region is anticipated to witness the fastest growth rate, driven by the increasing burden of ophthalmic disorders and rising consumer awareness. Countries like India and China are investing heavily in healthcare infrastructure, which will improve market penetration for ophthalmic drugs, including timolol maleate[1].

Key Players and Strategic Initiatives

Market Leaders

• Companies like Novartis AG, Regeneron Pharmaceuticals, Inc., and Alcon are key players in the ophthalmic drugs market. These companies are investing heavily in advanced technology and infrastructure to maintain high-quality standards and gain market share[1].

Recent Acquisitions and Partnerships

• Merck & Co.'s acquisition of EyeBio for up to $3 billion is a significant move, indicating a return to the eye drug development space. While this acquisition is more focused on novel therapeutics, it highlights the increasing investment in ophthalmic research and development, which can indirectly impact the market for established drugs like timolol maleate[2].

Financial Trajectory

Revenue and Growth

• The revenue from timolol maleate, as part of the broader ophthalmic drugs market, is expected to grow. The generic segment, in particular, is anticipated to drive this growth due to its cost-effectiveness and the expiry of patents for branded drugs[1].

Cost and Pricing Factors

• The financial trajectory of timolol maleate is influenced by cost and pricing factors. The low cost of generic drugs like timolol maleate makes them more accessible, but pricing can fluctuate based on competition and regulatory changes. For example, the price of methazolamide, another glaucoma drug, increased by 1,538% over five years due to low competition[5].

Challenges and Opportunities

Pricing Pressure and Regulatory Environment

• One of the challenges facing the market is pricing pressure, particularly in the U.S. market. Additionally, regulatory backlogs and the need for the FDA to review its backlog of abbreviated new drug applications can impact the availability and pricing of generic drugs like timolol maleate[5].

Increasing Demand and Technological Advancements

• The increasing prevalence of eye diseases and advancements in drug delivery mechanisms present opportunities for growth. The emergence of gene therapies and other novel treatments can also drive innovation and expansion in the ophthalmic drugs market[1].

Illustrative Statistics

• Market Size: The global ophthalmic drugs market was estimated at USD 37.82 billion in 2023[1].
• Growth Rate: The market is projected to grow at a CAGR of 8.34% from 2024 to 2030[1].
• Generic Segment Growth: The generic drugs segment is expected to witness the fastest growth rate due to cost-effectiveness and patent expiry of branded drugs[1].
• Regional Dominance: North America accounted for 44.99% of the global ophthalmic drugs market share in 2023[1].

Quotes from Industry Experts

"The EyeBio team has successfully assembled a pipeline of novel candidates with the potential to provide new treatment options for patients with retinal disease," said David R. Guyer, MD, EyeBio’s CEO and president. This highlights the ongoing innovation in the ophthalmic drugs market, which can indirectly benefit established drugs like timolol maleate[2].

Key Takeaways

• The global ophthalmic drugs market, including timolol maleate, is growing rapidly due to the rising prevalence of eye diseases and advancements in drug delivery.
• The generic segment, which includes timolol maleate, is expected to grow significantly due to cost-effectiveness and patent expiry.
• Regional markets, particularly North America and Asia Pacific, are key drivers of growth.
• Pricing dynamics and regulatory environments play crucial roles in the financial trajectory of timolol maleate.
• Increasing demand and technological advancements present opportunities for market expansion.

FAQs

1. What is the current market size of the global ophthalmic drugs market? The global ophthalmic drugs market was estimated at USD 37.82 billion in 2023[1].

2. What is the projected growth rate of the ophthalmic drugs market? The market is projected to grow at a CAGR of 8.34% from 2024 to 2030[1].

3. Why is the generic segment growing faster in the ophthalmic drugs market? The generic segment is growing faster due to its cost-effectiveness and the expiry of patents for branded drugs[1].

4. Which region dominates the ophthalmic drugs market? North America accounted for 44.99% of the global ophthalmic drugs market share in 2023[1].

5. What are the key challenges facing the timolol maleate market? Pricing pressure, particularly in the U.S. market, and regulatory backlogs are key challenges facing the timolol maleate market[5].

Cited Sources

1. Grand View Research: Ophthalmic Drugs Market Size & Share | Industry Report 2030
2. Genetic Engineering & Biotechnology News: Merck to Acquire EyeBio for Up to $3B, Re-Entering Eye Drug Space
3. Biocon: Relentless Pursuit. Differentiated Growth. - Biocon Integrated Annual Report 2023
4. Market Research Reports: Timolol Maleate Eye Drop - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030
5. Ophthalmology Management: The Role of Cost in the Branded vs. Generic Equation