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Last Updated: December 22, 2024

TIMOLOL Drug Patent Profile


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Which patents cover Timolol, and when can generic versions of Timolol launch?

Timolol is a drug marketed by Epic Pharma Llc, Somerset, Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs. and is included in fifty-six NDAs.

The generic ingredient in TIMOLOL is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Timolol

A generic version of TIMOLOL was approved as timolol maleate by MYLAN on June 8th, 1990.

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Drug patent expirations by year for TIMOLOL
Drug Prices for TIMOLOL

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Drug Sales Revenue Trends for TIMOLOL

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Recent Clinical Trials for TIMOLOL

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

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

See all TIMOLOL clinical trials

Pharmacology for TIMOLOL
Medical Subject Heading (MeSH) Categories for TIMOLOL

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
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072270-001 Apr 11, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pacific Pharma TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074746-001 Mar 25, 1997 AT1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074668-001 Mar 25, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 216653-001 Jul 3, 2024 AT2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Quantum Pharmics TIMOLOL MALEATE timolol maleate TABLET;ORAL 072467-001 May 19, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074466-001 Mar 25, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms TIMOLOL MALEATE timolol maleate TABLET;ORAL 072917-001 Jul 31, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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