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Last Updated: December 22, 2024

TIMOPTIC-XE Drug Patent Profile


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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-nine 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 8th, 1990.

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Summary for TIMOPTIC-XE
Drug patent expirations by year for TIMOPTIC-XE
Drug Prices for TIMOPTIC-XE

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Recent Clinical Trials for TIMOPTIC-XE

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

SponsorPhase
University of California, San DiegoN/A
Bausch & Lomb IncorporatedN/A
VA Office of Research and DevelopmentPhase 3

See all TIMOPTIC-XE clinical trials

Pharmacology for TIMOPTIC-XE

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb Inc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-002 Nov 4, 1993 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for TIMOPTIC-XE

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

Country Patent Number Title Estimated Expiration
Malaysia 8000138 OPHTHALMIC COMPOSITIONS ⤷  Subscribe
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. ⤷  Subscribe
Bulgaria 60332 ⤷  Subscribe
Australia 6318986 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TIMOPTIC-XE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0509752 2000C/001 Belgium ⤷  Subscribe 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 ⤷  Subscribe 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 ⤷  Subscribe 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 ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

TIMOPTIC-XE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TIMOPTIC-XE

Introduction

TIMOPTIC-XE, a sterile ophthalmic gel forming solution of timolol maleate, is a non-selective beta-adrenergic receptor blocking agent used in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. This article delves into the market dynamics and financial trajectory of TIMOPTIC-XE, exploring its clinical efficacy, market position, and financial implications.

Clinical Efficacy and Usage

TIMOPTIC-XE has been shown to be highly effective in lowering intraocular pressure. Clinical studies have demonstrated that it is equally effective when administered once daily compared to the equivalent concentration of TIMOPTIC administered twice daily[1][3].

  • The drug reduces aqueous formation and may slightly increase outflow facility, thereby lowering intraocular pressure consistently over a 24-hour period.
  • Its efficacy has been consistent over six months, making it a reliable option for long-term management of glaucoma and ocular hypertension.

Market Position

TIMOPTIC-XE is a branded product from Merck, which positions it within a competitive market of glaucoma medications.

  • Generic Competition: Generic versions of timolol, such as Betimol and Optipranolol, are available and can be more cost-effective. However, brand-name TIMOPTIC-XE has distinct physical characteristics, such as drop volume, viscosity, and surface tension, which can affect its interchangeability with generics[4].
  • Comparative Studies: Studies have shown that TIMOPTIC-XE is clinically and statistically equivalent to other formulations like timolol maleate gel-forming solution (GFS) in reducing intraocular pressure[4].

Financial Trajectory

The financial performance of TIMOPTIC-XE is closely tied to the overall financial health of its manufacturer, Merck.

Revenue and Earnings

  • Merck has reported significant revenue and earnings per share growth in various quarters. For instance, in the third quarter of 2007, Merck reported double-digit revenue and earnings per share growth, excluding restructuring charges[5].
  • While specific revenue figures for TIMOPTIC-XE are not publicly disclosed, the drug contributes to Merck's ophthalmology segment, which is part of the company's broader pharmaceutical portfolio.

Cost Analysis

  • The cost of TIMOPTIC-XE and other glaucoma medications can vary significantly. TIMOPTIC-XE, being a branded product, tends to be more expensive than generic alternatives, but it offers consistent efficacy and a convenient once-daily dosing regimen[4].
  • Cost analyses have shown that newer glaucoma medications, including TIMOPTIC-XE, can have similar costs per day compared to traditional medications, especially when considering the long-term management of glaucoma[4].

Market Trends and Competition

The glaucoma medication market is highly competitive, with various classes of drugs available, including beta-blockers, prostaglandin analogs, and carbonic anhydrase inhibitors.

  • Competitive Landscape: TIMOPTIC-XE competes with other beta-blockers like Betimol and Optipranolol, as well as with prostaglandin analogs like latanoprost and bimatoprost. The choice of medication often depends on the patient's specific condition, tolerance, and cost considerations[4].
  • Innovation and R&D: Continuous research and development in ophthalmology drive the introduction of new medications and formulations. This innovation can impact the market share of existing products like TIMOPTIC-XE, as newer drugs may offer improved efficacy or safety profiles.

Regulatory and Safety Considerations

  • Contraindications: TIMOPTIC-XE is contraindicated in patients with certain conditions such as bronchial asthma, severe chronic obstructive pulmonary disease, and cardiac issues like sinus bradycardia and overt cardiac failure[1][3].
  • Adverse Reactions: The drug can cause systemic side effects similar to those of systemic beta-adrenergic blocking agents, including respiratory and cardiac reactions. Local side effects include transient blurred vision and a slight reduction in resting heart rate[1][3].

Patient and Physician Preferences

  • Convenience: The once-daily dosing regimen of TIMOPTIC-XE enhances patient compliance, which is a significant factor in the long-term management of glaucoma.
  • Efficacy and Safety Profile: Physicians often prefer TIMOPTIC-XE due to its proven efficacy and safety profile, despite the higher incidence of transient blurred vision compared to other formulations[1][3].

Global Market Presence

  • International Clinical Trials: TIMOPTIC-XE has been studied in both U.S. and international clinical trials, demonstrating its global relevance and acceptance[1][3].
  • Pharmaceutical Company Performance: The global performance of Merck, including its financial results and market presence, influences the availability and marketing of TIMOPTIC-XE worldwide.

Future Outlook

The future of TIMOPTIC-XE in the market will depend on several factors:

  • Continued Innovation: Advances in ophthalmic medications and formulations could impact the market share of TIMOPTIC-XE.
  • Cost and Access: Changes in healthcare policies and reimbursement structures can affect the affordability and accessibility of the drug.
  • Patient and Physician Preferences: Ongoing clinical studies and real-world evidence will continue to shape preferences for TIMOPTIC-XE versus other glaucoma treatments.

Key Takeaways

  • Clinical Efficacy: TIMOPTIC-XE is highly effective in lowering intraocular pressure with a convenient once-daily dosing regimen.
  • Market Position: It competes in a crowded market with both branded and generic alternatives.
  • Financial Performance: The drug contributes to Merck's revenue, although specific figures are not disclosed.
  • Regulatory and Safety: It has specific contraindications and potential side effects that must be considered.
  • Patient and Physician Preferences: Convenience and efficacy are key factors in its preference.

FAQs

What is TIMOPTIC-XE used for?

TIMOPTIC-XE is used in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

How is TIMOPTIC-XE administered?

TIMOPTIC-XE is administered once daily as a sterile ophthalmic gel forming solution.

What are the common side effects of TIMOPTIC-XE?

Common side effects include transient blurred vision and a slight reduction in resting heart rate. Systemic side effects similar to those of systemic beta-adrenergic blocking agents can also occur.

Can TIMOPTIC-XE be used by patients with asthma?

No, TIMOPTIC-XE is contraindicated in patients with bronchial asthma or a history of bronchial asthma due to the risk of severe respiratory reactions.

How does TIMOPTIC-XE compare to generic alternatives?

TIMOPTIC-XE has distinct physical characteristics and is clinically and statistically equivalent to other formulations like timolol maleate gel-forming solution (GFS) in reducing intraocular pressure, but it tends to be more expensive than generic alternatives.

Cited Sources

  1. TIMOPTIC-XE® - Merck.com
  2. Q2 Fiscal Year 2021 Report - Santen Pharmaceutical
  3. TIMOPTIC-XE® 0.25% and 0.5% (TIMOLOL MALEATE ... - FDA
  4. Timoptic XE journal articles from PubMed - Unbound Medicine
  5. Merck Reports Double-Digit Revenue and Earnings Per Share Growth for Third Quarter 2007 - FierceBiotech

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