TIMOLOL MALEATE Drug Patent Profile

When do Timolol Maleate patents expire, and when can generic versions of Timolol Maleate launch?

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

The generic ingredient in TIMOLOL MALEATE 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 Maleate

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

Summary for TIMOLOL MALEATE

US Patents:	0
Applicants:	31
NDAs:	54
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	69
Patent Applications:	4,318
Drug Prices:	Drug price information 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

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/DROPS;OPHTHALMIC	074262-001	Apr 28, 1995	AT1	RX	No	Yes
Ingenus Pharms Llc	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	216533-002	Sep 13, 2022	AT3	RX	No	No
Ani Pharms	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072919-001	Jul 31, 1991		DISCN	No	No
Rising	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	207556-002	May 2, 2019	AB	RX	No	No
Somerset	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	217764-001	Jul 3, 2024	AT1	RX	No	No
Chartwell Rx	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072550-001	Apr 13, 1989		DISCN	No	No

Expired US Patents for TIMOLOL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-001	Oct 21, 1998
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-002	Oct 21, 1998

International Patents for TIMOLOL MALEATE

See the table below for patents covering TIMOLOL MALEATE around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2203103
Australia	740586
Turkey	200002848
European Patent Office	1069913	COMPOSITIONS OPHTALMIQUES GELIFIANTES, CONTENANT DE LA GOMME DE XANTHANNE (GELLING OPHTHALMIC COMPOSITIONS CONTAINING XANTHAN GUM)
Japan	4545927
Brazil	9910113

Supplementary Protection Certificates for TIMOLOL MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	2000C/001	Belgium		PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
0509752	49/1999	Austria		PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
0227494	95C0013	Belgium		PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
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

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]