BETIMOL Drug Patent Profile

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

Betimol is a drug marketed by Thea Pharma and is included in one NDA.

The generic ingredient in BETIMOL is timolol. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the timolol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Betimol

A generic version of BETIMOL was approved as timolol by SOMERSET on October 10^th, 2024.

Summary for BETIMOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Patent Applications:	7,692
Drug Prices:	Drug price information for BETIMOL
Drug Sales Revenues:	Drug sales revenues for BETIMOL
What excipients (inactive ingredients) are in BETIMOL?	BETIMOL excipients list
DailyMed Link:	BETIMOL at DailyMed

See drug prices for BETIMOL

See drug sales revenues for BETIMOL

Pharmacology for BETIMOL

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

US Patents and Regulatory Information for BETIMOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-001	Mar 31, 1995		DISCN	Yes	No
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-002	Mar 31, 1995	AT	RX	Yes	Yes

Expired US Patents for BETIMOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-001	Mar 31, 1995	5,231,095
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-002	Mar 31, 1995	5,231,095

International Patents for BETIMOL

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

Country	Patent Number	Title	Estimated Expiration
Austria	112277
Austria	154513
Australia	4329693
Australia	4347389
Australia	624431
Australia	678972
Brazil	9306800

Supplementary Protection Certificates for BETIMOL

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 22, 2026

BETIMOL (timolol) Eye Drops: Market Dynamics, Revenue Trajectory, and Competitive/Risk Outlook

BETIMOL (timolol maleate ophthalmic solution) is an established, low-to-mid single-digit U.S. ophthalmic brand whose commercial profile is dominated by generic timolol competition and payer-driven substitution. Financial trajectory is shaped primarily by (1) U.S. patent and exclusivity runway (if any remaining brand exclusivity), (2) Orange Book and FDA-listed generic entry status, and (3) contracting pressure in glaucoma and ocular hypertension lines of therapy.

Market-dynamics core: timolol remains a high-volume, commoditized therapy class. Brand economics typically compress quickly after generic availability and as formularies favor lower net-cost products. For BETIMOL specifically, the revenue trajectory is therefore expected to track the standard pattern for older ophthalmic molecules: early brand scale, then sustained share erosion, with any remaining premium dependent on remaining IP, limited protected presentation(s), and distribution or contracting differentiation rather than clinical differentiation.

What drives BETIMOL market share in U.S. ophthalmology?

BETIMOL’s share drivers in glaucoma and ocular hypertension care are mostly structural rather than product-specific.

How formulary design and contracting compress brand pricing

• Ophthalmic payers frequently implement step edits and tiering that steer toward the least expensive timolol options unless the prescriber documents intolerance or inadequate response.
• Net pricing is pressured through rebates, tendering, and class-based competitive floors, even when list price does not move materially.
• Timolol is commonly interchangeable at the class level, which increases substitution risk.

Why “same molecule” substitution is unusually strong for timolol

• The clinical endpoint in glaucoma is intraocular pressure (IOP) lowering. Across timolol products, substitution is typically treated as clinically routine by payers and pharmacy benefit managers.
• Multiple generic manufacturers and multiple strengths/presentation options increase “available-to-fill” leverage for pharmacy channels.

Patient adherence and bottle format still matter, but less than price

• If BETIMOL competes against cheaper options with similar dosing convenience, adherence advantages rarely offset cost gaps.
• Where preservative systems and dosing regimens differ meaningfully, they can support small niche pockets, but timolol formulations generally overlap across the market.

When does BETIMOL lose exclusivity in the U.S.?

A definitive exclusivity and patent-loss calendar for BETIMOL requires Orange Book and FDA labeling/patent listing data tied to the specific listed NDA(s) and the specific dosage form(s) under the BETIMOL label. That dataset is not present in the current prompt, so a complete and accurate exclusivity timeline cannot be produced.

What patents protect BETIMOL and how strong is the patent estate?

A patent-estate strength assessment depends on:

• Orange Book patent listings for the exact BETIMOL NDA(s),
• the specific claim types (composition, formulation, method-of-use, manufacturing),
• remaining term by jurisdiction, and
• any relevant litigation history (ANDA timing, Paragraph IV challenges, settlements).

Those inputs are not included in the prompt, so a complete patent-protection map cannot be generated without risking incorrect assertions.

Is BETIMOL listed in the Orange Book and what does that imply for generics?

Orange Book status determines whether ANDA applicants can pursue “paper” (non-infringing) routes or must wait for patent or exclusivity expiry. The prompt does not include the NDA number, Orange Book listing identifiers, or patent codes associated with BETIMOL, so Orange Book status cannot be stated accurately.

How many ANDA/generic competitors exist for BETIMOL timolol ophthalmic solution?

A count of ANDA approvals and the live market competitive set requires searching FDA’s Orange Book entries and approval history for the active ingredient at the specific dosage form and strength. Those data are not provided in the prompt, so competitor enumeration would be unreliable.

What generic entry risks exist for BETIMOL in each dosing form and strength?

Generic entry risk depends on:

• which presentation(s) BETIMOL actually markets (strength and bottle configuration),
• which specific listed patents cover that presentation, and
• whether there are remaining blocking patents or exclusivity.

Without NDA-specific formulation/presentation details and Orange Book patent coverage, entry-risk modeling for each strength cannot be completed accurately.

How does BETIMOL compare with other timolol brands and related glaucoma therapies on economics?

Timolol vs. prostaglandin analogs: pricing hierarchy

• Prostaglandin analogs often command higher drug-spend per patient but are favored by many formularies for efficacy and once-daily convenience.
• Timolol products typically compete on cost, not clinical differentiation, which makes brand economics sensitive to generic pricing spreads.

Timolol vs. fixed-combination products

• Fixed combinations (for example, timolol with other IOP-lowering agents) can reduce the substitution likelihood for the combined regimen.
• If BETIMOL competes only as monotherapy, it remains exposed to broad substitution across monotherapy timolol generics.

Switching dynamics

• Patients often cycle across classes based on efficacy tolerability and payer preference. When cost is the dominant driver, timolol monotherapy brand share erodes fastest once pricing parity is achievable through generics.

What financial trajectory should investors expect for BETIMOL under commoditization?

BETIMOL’s financial trajectory in a typical timolol market environment follows three phases:

1. Pre-generic scale and retention

   • Brand builds volume through clinician familiarity and early contract inclusion.

2. Generic-led revenue compression

   • As generics enter, branded revenue declines as prescriptions and refills move to lower net-cost products.
   • List-to-net economics deteriorate for remaining brand share, because rebates and contracting pressure rise while gross margin narrows.

3. Residual niche persistence

   • Brands can remain on formularies as a secondary option if they maintain a competitive net price or if specific presentations are constrained.
   • Growth is limited; the trajectory becomes largely a function of market size changes and competitive intensity rather than differentiated demand.

Commercial conclusion: For established timolol brands like BETIMOL, revenue tends to be flat-to-declining, with occasional small rebounds tied to short-lived protected presentations, contract changes, or channel mix shifts. Persistent growth is generally unlikely absent a meaningful proprietary advantage.

How does FDA regulatory status affect BETIMOL revenue and risk?

FDA status impacts:

• Whether BETIMOL is eligible for substitution and interchangeability considerations,
• whether generics are approved for the same strength/presentation, and
• how quickly additional competing products come to market.

The prompt provides no FDA pathway, approval history, or interchangeability detail for BETIMOL, so regulatory impact cannot be quantified.

What litigation or settlements could affect BETIMOL’s branded lifecycle?

Patent litigation and Paragraph IV settlements can delay generic entry and preserve branded sales. The prompt contains no litigation dataset, no court docket references, and no settlement terms. A litigation-based timeline cannot be produced.

Where does BETIMOL sit in the competitive landscape for glaucoma drops?

BETIMOL competes in a crowded landscape:

• Generics dominate timolol monotherapy.
• Alternative classes (prostaglandins, beta blockers in other formats, carbonic anhydrase inhibitors, alpha agonists) compete for formulary placement.
• Fixed combinations can shift volume away from monotherapy timolol.

Market position is therefore typically constrained to payers and clinicians prioritizing low cost and established regimens.

Revenue exposure scenarios for BETIMOL: base, downside, upside

Because the prompt does not include BETIMOL’s revenue history, market share, net price, or NDA-specific exclusivity, scenario modeling with quantified thresholds cannot be constructed without introducing fabricated numbers.

Key Takeaways

• BETIMOL’s market dynamics are dominated by generic timolol substitution, payer tiering, and net price pressure in glaucoma care.
• The commercial trajectory for older, established timolol brands is typically flat-to-declining after generic entry, with limited upside unless a specific presentation remains protected or constrained.
• A precise exclusivity, patent-expiration, Orange Book, ANDA/generic entry, and litigation timeline for BETIMOL cannot be stated from the provided input.

FAQs

1. Does BETIMOL face biosimilar risk?
   No. BETIMOL is a small-molecule ophthalmic drug, so biosimilar frameworks do not apply.

2. How does timolol substitution usually impact branded ophthalmic revenues?
   It typically compresses revenue as pharmacies and payers shift prescriptions to lower net-cost generics within the timolol class.

3. Can presentation differences (preservative or bottle format) extend BETIMOL profitability?
   They can create narrow differentiation, but economics still tend to erode when equivalent generic presentations are available at scale.

4. What matters most for BETIMOL’s next phase of competition?
   The remaining Orange Book/patent or exclusivity protection for the specific NDA presentation under the BETIMOL label, plus the timing and strength of generic approvals.

5. What is the biggest operational lever for BETIMOL market access?
   Contracting and formulary strategy that governs net pricing and preferred status versus competing timolol products.

References

1. Not provided in the prompt.