ISTALOL Drug Patent Profile

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

Istalol is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in ISTALOL 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 Istalol

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

Summary for ISTALOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4,925
Drug Prices:	Drug price information for ISTALOL
What excipients (inactive ingredients) are in ISTALOL?	ISTALOL excipients list
DailyMed Link:	ISTALOL at DailyMed

See drug prices for ISTALOL

See drug sales revenues for ISTALOL

Recent Clinical Trials for ISTALOL

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

Sponsor	Phase
Bp Consulting, Inc	Phase 4

See all ISTALOL clinical trials

Pharmacology for ISTALOL

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

Paragraph IV (Patent) Challenges for ISTALOL

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 ISTALOL

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	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	AT2	RX	Yes	Yes

Expired US Patents for ISTALOL

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
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004

International Patents for ISTALOL

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

Country	Patent Number	Title	Estimated Expiration
Japan	4377052
Canada	2307303	COLLYRES A LIBERATION PROLONGEE (PROLONGED-ACTION EYE DROP)
Spain	2297894
European Patent Office	1029537	COLLYRES A LIBERATION PROLONGEE (SUSTAINED RELEASE EYEDROPS)
China	1124842

Supplementary Protection Certificates for ISTALOL

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 ISTALOL (Timolol Maleate)

Last updated: July 29, 2025

Introduction

ISTALOL, a proprietary formulation of Timolol Maleate, is a beta-adrenergic blocker predominantly indicated for the treatment of glaucoma and ocular hypertension. As a cornerstone in ophthalmic therapeutics, ISTALOL's market and financial performance are shaped by evolving regulatory landscapes, clinical advancements, competitive pressures, and healthcare economic factors. This comprehensive analysis explores these aspects, offering insights vital for stakeholders aiming to navigate its market trajectory effectively.

Pharmacological Profile and Clinical Adoption

Timolol Maleate, marketed under various brand names including ISTALOL, is recognized for its efficacy in lowering intraocular pressure (IOP). Its mechanism involves non-selective beta-adrenergic receptor blockade, reducing aqueous humor production. The drug's long-standing clinical utility has cemented its position in glaucoma management, influencing sustained demand across global markets.

Market Dynamics

Epidemiological Drivers

The increasing global prevalence of glaucoma, projected to affect over 80 million individuals by 2040, underpins the demand for ophthalmic therapeutics like ISTALOL. Age-related ocular degeneration, rising myopia, and lifestyle factors contribute to this epidemiology. Regions such as Asia-Pacific and Latin America are witnessing rapid growth due to demographic shifts, urbanization, and improved healthcare access.

Regulatory Landscape

Regulatory agencies across key markets—including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the China National Medical Products Administration (NMPA)—continue to oversee the approval, manufacturing standards, and patent protections of ophthalmic drugs. Patent expirations of branded timolol products often catalyze market entries of generic equivalents, intensifying competition but also expanding access.

Competitive Environment

The glaucoma pharmacotherapy segment is highly competitive, with key players like Novartis (Xalatan), Allergan (Brimonidine), and Santen (Rimo 0.25%). ISTALOL's market share hinges on factors such as formulation advantages, cost competitiveness, and clinical reputation. Generic formulations of timolol exert downward pressure on prices, impacting revenue streams of branded counterparts.

Healthcare Economics and Reimbursement

In developed markets, reimbursement policies significantly influence prescribing patterns. Cost-effective generic ISTALOL benefits from favorable insurance coverage, enhancing market penetration. Conversely, in low-resource settings, affordability remains a barrier, limiting expansion.

Technological and Formulation Innovations

Advancements such as sustained-release implants, fixed-dose combinations, and preservative-free formulations are reshaping the ophthalmic landscape. ISTALOL's potential integration into such innovations could diversify its product offerings and market appeal.

Financial Trajectory

Historical Revenue and Sales Trends

Globally, timolol-based formulations have generated substantial sales figures. While precise proprietary data on ISTALOL is proprietary, analysis of the broader timolol market indicates steady growth, driven by consistent demand and expanding indications. The global glaucoma therapeutics market is valued at approximately USD 4 billion in 2022 and growing at an annual rate of about 5% (CAGR), with timolol accounting for a significant share.

Impact of Patent Lifecycles

Patent expirations around the early 2010s led to increased generic competition, compressing profit margins and shifting revenue to price-sensitive markets. Current financial trajectories depend on the duration of patent exclusivity, with some formulations scheduled for generic entry within the next few years.

Market Penetration Strategies

Manufacturers of ISTALOL are investing in clinical differentiations, physician education, and patient adherence initiatives to sustain revenue. Strategic collaborations with healthcare providers and payers aim to bolster market share amid a commoditized landscape.

Emerging Markets and Expansion

Growth projections for emerging economies are optimism-inducing, driven by improved healthcare infrastructure and increasing glaucoma awareness. These markets present significant revenue potential for ISTALOL, especially as affordability barriers decline and generic options proliferate.

Challenges and Opportunities

Challenges

• Pricing Pressures: Heightened competition from generic formulations suppresses prices.
• Regulatory Barriers: Stringent approval processes and patent disputes may delay market entry in new regions.
• Market Saturation: Mature markets face slow growth due to existing treatment adoption and treatment adherence issues.

Opportunities

• Product Innovation: Development of preservative-free or sustained-release versions can capture unmet needs.
• Expanding Indications: Exploring off-label uses or combination therapies could elevate revenues.
• Market Diversification: Penetrating developing economies offers high growth potential with tailored pricing strategies.

Future Outlook

The financial trajectory of ISTALOL hinges on its ability to adapt to patent thresholds, innovate with formulations, and leverage emerging market opportunities. While patent expirations threaten revenue streams, strategic investments in next-generation formulations and market expansion can offset declines and foster long-term growth. The global shift towards value-based healthcare emphasizes the importance of cost-effectiveness, positioning ISTALOL favorably if it maintains competitive pricing.

Projected Compound Annual Growth Rate (CAGR) for ISTALOL-specific sales is expected to align with the broader ophthalmic market, maintaining a moderate growth trajectory of approximately 3-4% in the next five years, contingent on strategic implementation and market dynamics.

Key Takeaways

• The global glaucoma market is expanding, fueled by demographic and lifestyle factors, maintaining steady demand for timolol formulations like ISTALOL.
• Patent expirations and increased generic competition exert downward pressure on pricing but also broaden access and market reach.
• Innovation in formulations and expanding indications can sustain revenue streams amidst generic entry.
• Emerging markets represent significant growth avenues, driven by increasing healthcare access and glaucoma prevalence.
• Strategic pricing, partnerships, and technological advancements are critical for optimizing ISTALOL's financial trajectory.

FAQs

1. What differentiates ISTALOL from other timolol formulations?
   ISTALOL's differentiation hinges on its formulation quality, preservative profile, and potential for combination therapy integration, although generic versions often share similar active ingredients.

2. How will patent expirations impact ISTALOL's market share?
   Expiring patents typically lead to increased generic entries, reducing prices and narrowing profit margins. However, brand owners can mitigate this through product innovation and expanding indications.

3. Are there upcoming regulatory changes that could influence ISTALOL?
   Regulatory shifts favoring biosimilar and generic approvals, as well as stricter safety standards, may influence market access and competitive dynamics.

4. What are the growth prospects in emerging markets for ISTALOL?
   These markets offer substantial growth opportunities due to rising glaucoma rates and healthcare infrastructure improvements, provided pricing and distribution strategies are adapted effectively.

5. Can technological innovations rejuvenate ISTALOL's market position?
   Yes. Innovations like sustained-release implants and preservative-free formulations can differentiate ISTALOL, attract new patient segments, and command premium pricing.

---

Sources:

1. World Health Organization. "Glaucoma." 2021.
2. MarketWatch. "Global Glaucoma Therapeutics Market Analysis." 2022.
3. EvaluatePharma. "Ophthalmic Drugs Market Trends." 2023.
4. U.S. FDA. "Timolol Maleate Drug Approvals and Patent Data." 2022.
5. Statista. "Forecast of the Global Ophthalmic Drugs Market." 2023.