TIMOPTIC Drug Patent Profile

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

Timoptic is a drug marketed by Bausch And Lomb Inc and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Timoptic

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

Summary for TIMOPTIC

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	19
Patent Applications:	4,594
Drug Prices:	Drug price information for TIMOPTIC
Drug Sales Revenues:	Drug sales revenues for TIMOPTIC
What excipients (inactive ingredients) are in TIMOPTIC?	TIMOPTIC excipients list
DailyMed Link:	TIMOPTIC at DailyMed

See drug prices for TIMOPTIC

Recent Clinical Trials for TIMOPTIC

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

Sponsor	Phase
University of California, San Diego	N/A
Bausch & Lomb Incorporated	N/A
VA Northern California Health Care System	Phase 3

See all TIMOPTIC clinical trials

Pharmacology for TIMOPTIC

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

US Patents and Regulatory Information for TIMOPTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982	AT1	RX	Yes	No
Bausch And Lomb Inc	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	AT3	RX	Yes	Yes
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982	AT1	RX	Yes	No
Bausch And Lomb Inc	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-001	Nov 5, 1986	AT3	RX	Yes	Yes
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	AB	RX	Yes	No
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-001	Nov 4, 1993	AB	RX	Yes	No

Expired US Patents for TIMOPTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982

International Patents for TIMOPTIC

See the table below for patents covering TIMOPTIC around the world.

Country	Patent Number	Title	Estimated Expiration
France	2070067
Mexico	9202807	CONPOSICIONES Y METODOS PARA TRATAMIENTO DE GLAUCOMA POR LA ADMINISTRACION TOPICA DE T-BUTILAMINO-3(4-MORFOLIN-1,2,5-TIADIAZOL-3-ILOXI-2-PROPANOL HIDROGENO MALEATO.
Ireland	44167	OPHTHALMIC COMPOSITIONS
United Kingdom	1524405
Canada	945165
France	2009110

Supplementary Protection Certificates for TIMOPTIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
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

Market Dynamics and Financial Trajectory for TIMOPTIC

Last updated: July 29, 2025

Introduction

TIMOPTIC, a branded ophthalmic product principally containing timolol maleate, occupies a pivotal position in glaucoma management. As a non-selective beta-adrenergic blocker, TIMOPTIC effectively reduces intraocular pressure (IOP), serving as a mainstay in open-angle glaucoma and ocular hypertension treatment. Understanding its market dynamics and financial trajectory requires a comprehensive analysis of therapeutic demand, competitive landscape, regulatory factors, and economic considerations shaping its commercial viability.

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Market Overview and Therapeutic Demand

Glaucoma remains a leading cause of irreversible blindness globally, with an estimated 76 million affected patients in 2020, projected to reach over 111 million by 2040 [1]. TIMOPTIC's primary indication aligns directly with this prevalence, capitalizing on a large, steady demand base. The global ophthalmic therapeutics market, estimated at USD 16 billion in 2022, includes a significant pharmacologic segment dominated by treatments like TIMOPTIC [2].

The continual rise in glaucoma awareness, coupled with increased screening, sustains steady demand. Moreover, the prevalence of ocular hypertension as a precursor condition amplifies this demand. Demographic shifts, notably aging populations in North America, Europe, and parts of Asia, further underpin the sustained need for IOP-lowering agents.

Competitive Landscape

TIMOPTIC operates in a highly competitive environment featuring generics, branded counterparts, and alternative drug classes. Key competitors include:

• Branded competitors: Xalatan (latanoprost), Travatan Z (travoprost) — prostaglandin analogs with comparable efficacy but different side effect profiles.
• Generic timolol formulations: Historically significant, often offering lower-cost options with similar efficacy.
• Combination therapies: Fixed-dose combinations (e.g., timolol with brimonidine) gaining popularity for improved compliance.

The entry of generics post-patent expiry significantly impacts TIMOPTIC’s pricing and market share. Patent expirations, observed in key markets around the late 2010s, have facilitated a surge in low-cost alternatives, pressuring revenue streams for TIMOPTIC.

Regulatory and Patent Considerations

TIMOPTIC’s original patents, dating back several decades, have naturally expired or are nearing expiration in many jurisdictions, leading to increased generic competition [3]. While some formulations may benefit from secondary patents or exclusivity rights, these are often short-lived.

Regulatory frameworks in major markets, such as the FDA in the U.S. and EMA in Europe, influence market access and pricing strategies. Stringent approval processes for efficacy and safety reaffirm the drug’s profile but can delay or limit market expansion for newer formulations or patents.

Pricing Strategies and Reimbursement Policies

Pricing remains a critical factor. Branded TIMOPTIC commands premium pricing in markets with limited generic penetration or where patent protection persists. Conversely, in markets with widespread generic availability, price erosion occurs rapidly.

Reimbursement policies increasingly favor cost-effective therapies. The shift towards value-based care in countries like the U.S. and member states of the EU pressures providers to favor generics or more cost-efficient alternatives, influencing TIMOPTIC’s market share and revenue potential.

Market Penetration and Adoption Trends

Data indicates that TIMOPTIC maintains strong clinical preference among ophthalmologists for its proven efficacy and tolerability. Its adoption is higher in regions with established healthcare infrastructure, notably North America and Europe.

However, the advent of newer pharmacological agents and sustained-release device formulations poses competition. While the latter promises enhanced patient compliance, their high development costs and uncertain regulatory pathways affect their immediate impact.

Economic and Revenue Trajectory

Despite patent expiries and competition, TIMOPTIC remains a financially significant drug, bolstered by the chronic nature of glaucoma requiring long-term therapy. Its revenues, however, are declining in mature markets due to factors such as:

• Market saturation
• Generics’ price competition
• Shift towards alternative therapies

Conversely, emerging markets such as Asia-Pacific and Latin America present growth opportunities driven by increasing glaucoma prevalence and expanding healthcare access. Localization and differential pricing strategies could position TIMOPTIC as a cost-effective treatment in these regions.

Projected Revenue Trends:

• Short-term (1–3 years): Revenue stabilization in some mature markets, with slight declines due to generic erosion.
• Medium-term (4–7 years): Potential growth in emerging markets, contingent on regulatory approvals and market expansion strategies.
• Long-term (8+ years): Uncertain, heavily influenced by innovation, patent litigations, and competitive drug development.

Continued patent strategies or the development of novel formulations (e.g., sustained release, fixed-dose combinations) could restore revenue growth, although these avenues face significant R&D hurdles and regulatory challenges.

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Future Outlook and Strategic Considerations

The future of TIMOPTIC hinges on strategic adaptability. Pharmaceutical companies may focus on:

• Line extension: Developing sustained-release formulations or combination therapies.
• Market expansion: Targeting underpenetrated regions through tailored pricing and distribution.
• Intellectual property management: Securing secondary patents or exclusivity rights.
• Digital health integration: Promoting adherence through digital monitoring tools.

Further, the increasing emphasis on biosimilars and generics necessitates proactive patent litigation and lifecycle management to maintain profitability.

Conclusion

TIMOPTIC’s market dynamics are characterized by robust therapeutic demand within a competitive and regulated landscape. While patent expiries and generic competition exert downward pressure on pricing, emerging markets and strategic innovation offer avenues for maintaining its economic relevance. The drug’s financial trajectory will largely depend on successful diversification strategies, regulatory navigation, and ongoing adoption of synergistic therapies.

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Key Takeaways

• The global glaucoma burden underpins sustained demand for TIMOPTIC, especially in aging populations.
• Patent expirations and generics erode revenues in mature markets; emerging markets present growth potential.
• Competitive dynamics favor cost-effective therapies, pressuring branded product pricing.
• Innovative formulations and combination therapies are vital to extending TIMOPTIC’s market lifespan.
• Strategic market expansion and lifecycle management are essential for future profitability.

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FAQs

1. How does patent expiration affect TIMOPTIC’s market share?
Patent expiration typically leads to increased generic competition, undercutting pricing and reducing the market share of branded TIMOPTIC. This results in revenue declines unless offset by strategic innovations or market expansion.

2. What are the primary competitors to TIMOPTIC in glaucoma management?
Key competitors include prostaglandin analogs like Latanoprost (Xalatan), other beta-blockers such as betaxolol, and combination therapies. Generic timolol formulations also intensify competition.

3. Is there significant potential for TIMOPTIC in emerging markets?
Yes, rising glaucoma prevalence and expanding healthcare systems in Asia, Latin America, and Africa offer growth opportunities, especially if priced competitively and integrated within local healthcare frameworks.

4. Can innovation prolong TIMOPTIC’s market relevance?
Absolutely. Development of sustained-release formulations, combination drugs, and digital adherence tools can enhance efficacy, compliance, and ultimately extend its commercial lifespan.

5. How do regulatory policies influence TIMOPTIC’s future prospects?
Stringent regulatory standards can delay market entry or approval of new formulations, but effective navigation and compliance can secure market access and safeguard exclusivity, impacting its financial trajectory positively or negatively.

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References

[1] Tham Y-C, et al. "Global Prevalence of Glaucoma and Projections of the Number of People Affected." Ophthalmology, 2014.
[2] MarketResearch.com. "Ophthalmic Drugs Market Size & Trends." 2022.
[3] U.S. Patent and Trademark Office. "Patent Status of TIMOPTIC and Related Formulations." 2022.