TIMOPTIC-XE Drug Patent Profile

When do Timoptic-xe patents expire, and what generic alternatives are available?

Timoptic-xe is a drug marketed by Bausch And Lomb Inc and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Timoptic-xe

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

Summary for TIMOPTIC-XE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	19
Patent Applications:	5,143
Drug Prices:	Drug price information for TIMOPTIC-XE
What excipients (inactive ingredients) are in TIMOPTIC-XE?	TIMOPTIC-XE excipients list
DailyMed Link:	TIMOPTIC-XE at DailyMed

See drug prices for TIMOPTIC-XE

Recent Clinical Trials for TIMOPTIC-XE

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

Sponsor	Phase
University of California, San Diego	N/A
Bausch & Lomb Incorporated	N/A
VA Office of Research and Development	Phase 3

See all TIMOPTIC-XE clinical trials

Pharmacology for TIMOPTIC-XE

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

US Patents and Regulatory Information for TIMOPTIC-XE

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-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-001	Nov 4, 1993	AB	RX	Yes	No
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	AB	RX	Yes	No

Expired US Patents for TIMOPTIC-XE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-001	Nov 4, 1993	4,195,085
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	4,195,085
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	4,861,760
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-001	Nov 4, 1993	4,861,760

International Patents for TIMOPTIC-XE

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

Country	Patent Number	Title	Estimated Expiration
Australia	1771476
Australia	513280
Belgium	846574
Bulgaria	60332
Cyprus	1023	OPHTALMIC COMPOSITIONS
United Kingdom	1524405
Hong Kong	67579	OPHTHALMIC COMPOSITIONS

Supplementary Protection Certificates for TIMOPTIC-XE

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	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	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	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

Last updated: July 16, 2026

TIMOPTIC-XE market dynamics and financial trajectory: revenue drivers, competitive threats, and IP/generic risk

TIMOPTIC-XE (timolol maleate ophthalmic solution extended-release) revenue trajectory depends on two forces: (1) steady chronic glaucoma market demand driven by aging and adherence to once-daily therapy, and (2) competitive pressure from generic ophthalmic timolol formulations and alternative glaucoma drug classes that expand the addressable population and shift patients off timolol monotherapy. From a financial standpoint, TIMOPTIC-XE behaves like an “older ingredient, brand-optimized delivery” product where growth is capped and share is vulnerable once exclusivity and patent barriers erode.

Key business read-through: timolol-based products typically face rapid pricing pressure after generic entry of the base active ingredient. TIMOPTIC-XE’s extended-release attribute can preserve premium pricing relative to immediate-release timolol, but it does not eliminate substitution risk across multiple glaucoma classes (prostaglandin analogs, alpha-agonists, carbonic anhydrase inhibitors) and across timolol products (solution, gel, and “extended effect” formulations).

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What drives TIMOPTIC-XE demand in the glaucoma market?

Primary demand driver: chronic disease prevalence. Glaucoma requires long-term, often lifelong, treatment. TIMOPTIC-XE competes in the portion of the market where clinicians use beta-blockers first-line, as adjunct therapy, or as add-on when intraocular pressure targets are not met with other classes.

Core usage pattern: once-daily adherence advantage. Extended-release timolol is designed to reduce dosing frequency versus immediate-release beta-blockers. In the ophthalmic setting, reduced dosing friction supports persistence and reduces missed doses, which can support share relative to multi-daily regimens.

Reimbursement and formulary structure. Ophthalmology formularies often favor low acquisition cost generics within a mechanism class. A branded extended-release product can keep access when:

• payers allow a “preferred brand” tier for adherence or clinical differentiation,
• provider networks have historical prescribing patterns,
• patients remain stable on the regimen and refills are ongoing.

Commercial KPI implications

• Share retention is driven more by ongoing patient conversion and refill continuity than by new prescriber adoption late in the product life cycle.
• Growth is typically modest; revenue protection relies on pricing discipline and low channel inventory volatility.

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How does TIMOPTIC-XE pricing evolve versus generic timolol ophthalmics?

Pricing is usually the first financial pressure point. Timolol is an established, widely generically available active. Even where an extended-release label supports a premium, payer and physician substitution commonly drive down net price over time.

Typical pricing trajectory for “delivery-differentiated” timolol brands

• Pre-generic base erosion: brand holds premium pricing.
• Post-generic entry of base timolol: net price compresses; gross-to-net increases with rebates and access conditions.
• Late lifecycle: brand survives at a narrower price premium. Revenue depends on residual differentiation (tolerability, adherence) and local formulary behavior.

What matters for net revenue, not list price

• Contract rebates and formulary placement determine net price.
• Patient out-of-pocket and insurer step therapy can accelerate switching to generics.

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Where does TIMOPTIC-XE sit in the competitive glaucoma landscape?

TIMOPTIC-XE competes within beta-blocker therapy alongside:

• generic timolol solutions and gels,
• branded or prescription-only timolol variants where still protected by formulation or delivery patents,
• combination drops that include beta-blocker plus another mechanism.

It also faces cross-class displacement risk from:

• prostaglandin analogs (often first-line due to dosing convenience and efficacy),
• fixed combinations that simplify regimens (higher persistence once prescribed),
• newer agents in market segments depending on geography and formulary.

Share dynamics

• In mature markets, prostaglandin analogs often dominate initiation. Beta-blockers keep share through add-on use and tolerability.
• Extended-release timolol can retain use in patients stable on the brand or those where clinician experience favors the delivery profile.

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Which generic entry risks exist for TIMOPTIC-XE?

Generic substitution risk is structural. Once base timolol ophthalmics face generic availability, “brand-extended-release” products typically see:

• switching by payers through formulary updates,
• prescriber switching for new starts,
• pharmacy-level substitution for patients not locked into brand-only dispensing.

IP-driven risk categories that affect launch timing

• composition/patent-of-ingredient: timolol itself is long past typical composition exclusivity.
• formulation and delivery patents: extended-release mechanisms and excipient systems can delay full substitution.
• method-of-use: if any are tied to dosing regimens or therapeutic use, they can affect Paragraph IV strategy.
• regulatory exclusivity: if any data exclusivity attaches to a particular NDA, it can delay generic approval; timolol products often do not carry long modern exclusivity given age.

Financial impact pattern

• At and around generic entry, the market typically transitions from brand premium to brand parity or accelerated volume loss.
• Revenue tends to step down sharply after the first meaningful competitor launches, then stabilizes at lower net revenue if the brand retains a subset of patients.

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What patents protect TIMOPTIC-XE, and when do they expire?

No complete, reliable patent estate for TIMOPTIC-XE can be produced from the information available in this prompt. Without a validated Orange Book listing and patent number set for TIMOPTIC-XE (including assignee, listed claim scope, and expiration dates), any attempt to state “what patents protect it” or “when they expire” would not meet an accuracy standard for litigation, licensing, or investment decisioning.

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What is the Orange Book status of TIMOPTIC-XE?

No Orange Book status details (application holder, patent list, expiration dates, exclusivity codes) are provided in the prompt. Without a verified Orange Book extract for TIMOPTIC-XE, a complete status and exclusivity timeline cannot be stated.

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When does TIMOPTIC-XE lose exclusivity, and how does that change revenue?

No exclusivity timeline for TIMOPTIC-XE is provided. Without confirmed patent term end dates and regulatory exclusivity fields, a revenue timing analysis tied to specific expiration events cannot be completed in a way that is actionable for competitive strategy.

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How does TIMOPTIC-XE financial performance compare with other glaucoma drop categories?

Revenue profile expected for older beta-blocker delivery brands

• Lower growth than newer class leaders due to mature market share.
• Stability driven by refill patterns and “stable patient cohorts.”
• Higher sensitivity to price compression after generic entry.

Expected relative behavior versus high-patent-risk categories

• Prostaglandin analog leaders often sustain longer due to both clinical positioning and brand/patent strategy in specific markets, though many have generics too.
• Combination drops can create stickier revenue if they are positioned for multi-mechanism lowering with dosing simplicity.

TIMOPTIC-XE’s financial trajectory is likely to track “brand beta-blocker resilience” rather than “innovation premium growth.”

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What commercialization levers protect TIMOPTIC-XE revenues?

1) Formulary retention and access management

• Maintaining tier positioning and avoiding exclusion.
• Agreements with PBMs and payers that keep net pricing viable.

2) Patient continuity

• Limited switching for stable patients who report tolerability and adequate control.
• Pharmacy dispensing practices that reduce generic substitution, when allowed by benefit design.

3) Physician preference in add-on scenarios

• In patients already on other agents, beta-blockers can be adjunct. Even after generic availability, brand continuity can persist when clinicians prefer a known regimen.

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What generic entry and settlement scenarios could affect TIMOPTIC-XE?

No Paragraph IV filings, district court cases, or settlement agreements for TIMOPTIC-XE are specified in the prompt. Without cited case identifiers, a scenario analysis that affects launch timing and payment risk cannot be produced to decision-grade accuracy.

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What FDA pathway and regulatory status considerations matter for TIMOPTIC-XE?

No FDA filing pathway, listed dosage forms, or regulatory status details are provided in the prompt. Without confirmed NDA and supplement structure, it is not possible to map:

• any 505(b)(2) versus ANDA implications,
• interchangeability assumptions for substitution,
• data exclusivity or patent linkage status.

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How do manufacturing and supply constraints influence TIMOPTIC-XE revenue?

For ophthalmic solutions, revenue shocks can arise from:

• sterility assurance and fill-finish capacity constraints,
• container closure system and stability limits,
• quality deviations that trigger market withdrawals or allocation.

No supply chain events for TIMOPTIC-XE are provided in the prompt, so a specific financial impact cannot be quantified.

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Key takeaways

• TIMOPTIC-XE’s market dynamics are governed by chronic glaucoma demand, adherence effects from extended-release dosing, and the economics of substitution across generic timolol and other glaucoma drug classes.
• Financial trajectory in mature beta-blocker markets typically shows low growth with net price compression risk and volume sensitivity to formulary changes after meaningful generic entry.
• Decision-grade patent and exclusivity timing analysis cannot be completed from the information provided in the prompt because Orange Book and patent listing facts are not included.

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FAQs

1) Does TIMOPTIC-XE face faster substitution than immediate-release timolol?
Substitution speed depends more on formulary access and net pricing than on dosing format once generics are available; extended-release can slow switch rates but rarely prevents it.

2) What therapy line is TIMOPTIC-XE most likely to serve: first-line or add-on?
Beta-blockers commonly function as add-on or alternative therapy when targets are not met with prostaglandin analogs or when tolerability dictates.

3) How do PBM formulary rules typically affect ophthalmic timolol brands?
PBMs often steer access toward lowest net-cost equivalents within a mechanism class, which compresses branded net revenue over time.

4) Are glaucoma drops primarily revenue-protected by patents or by formulary behavior?
In mature actives like timolol, formulary placement and rebate economics often drive the realized revenue more than patent coverage alone.

5) What is the most common financial impact after generic entry of timolol ophthalmics?
A step-down in branded volume and increased net price pressure due to rebate and access dynamics.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-16).