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Last Updated: December 22, 2024

TIMOPTIC Drug Patent Profile


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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-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

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

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

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Recent Clinical Trials for TIMOPTIC

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

See all TIMOPTIC clinical trials

Pharmacology for TIMOPTIC

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb Inc TIMOPTIC IN OCUDOSE timolol maleate SOLUTION/DROPS;OPHTHALMIC 019463-002 Nov 5, 1986 AT3 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch And Lomb Inc TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 AT1 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

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 3,655,663 ⤷  Subscribe
Bausch And Lomb Inc TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 4,195,085 ⤷  Subscribe
Bausch And Lomb Inc TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 3,655,663 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TIMOPTIC

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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

TIMOPTIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TIMOPTIC

Overview of TIMOPTIC

TIMOPTIC, also known as timolol maleate ophthalmic solution, is a medication used to reduce elevated intraocular pressure, a major risk factor in the pathogenesis of glaucomatous visual field loss and optic nerve damage. It is administered topically to the eye and is effective in reducing both elevated and normal intraocular pressure[4].

Market Size and Growth

The ophthalmic drugs market, which includes TIMOPTIC, is experiencing significant growth. The global ophthalmic drugs market was estimated at USD 37.82 billion in 2023 and is projected to grow at a CAGR of 8.34% from 2024 to 2030. This growth is driven by the rising prevalence of retinal disorders, advancements in drug delivery, and increasing investment in research and development of novel therapeutics[1].

Segment Performance

TIMOPTIC falls under the category of glaucoma treatments, which is a substantial segment within the ophthalmic drugs market. The market is characterized by a high degree of innovation, particularly in drug delivery mechanisms. The emergence of new pharmacologic agents and more effective delivery methods for existing agents are key drivers of market growth[1].

Financial Performance of Bausch Health

Bausch Health, the company behind TIMOPTIC, has reported mixed financial results in recent years. In the fourth quarter and full year of 2021, Bausch Health reported revenues of $2,196 million and $3,765 million, respectively. While the company saw a 10% increase in revenues compared to the previous year, it also faced challenges such as reduced cash flows from operations due to the impact of COVID-19[2][5].

Revenue Contribution

TIMOPTIC, specifically the Timoptic Ocudose formulation, contributes to Bausch Health's ophthalmology segment. In the fourth quarter of 2020, the ophthalmology segment, which includes TIMOPTIC, generated significant revenue. However, the exact contribution of TIMOPTIC to the overall revenue is not explicitly stated in the financial reports. It is part of the broader ophthalmology portfolio that has seen fluctuations but overall positive trends in revenue[2][5].

Competitive Landscape

The ophthalmic drugs market is highly competitive, with various players focusing on innovative drug delivery systems and novel therapeutics. Anti-VEGF agents, for example, led the market in 2023, accounting for 32.71% of the global revenue. However, generic drugs, including those similar to TIMOPTIC, are projected to witness the fastest growth rate due to their cost-effectiveness and the expiry of patents for branded drugs[1].

Regional Market Dynamics

North America dominates the ophthalmic drugs market, accounting for a 44.99% share in 2023. This is due to the high prevalence of retinal diseases and favorable government initiatives in the region. The Asia Pacific region is anticipated to witness the fastest growth, driven by the increasing burden of ophthalmic disorders and rising consumer awareness[1].

Product Efficacy and Safety

TIMOPTIC has been shown to be effective in reducing intraocular pressure, with the onset of reduction detectable within one-half hour after a single dose and the maximum effect occurring in one to two hours. It is generally well-tolerated and produces fewer and less severe side effects compared to other treatments like pilocarpine and epinephrine[4].

Market Drivers and Restraints

  • Drivers: Rising prevalence of retinal disorders, advancements in drug delivery, increasing investment in research and development, and favorable government initiatives.
  • Restraints: High development costs, stringent regulatory approvals, and competition from generic drugs[1].

Future Outlook

The market for ophthalmic drugs, including TIMOPTIC, is poised for significant growth. The emergence of gene therapies and other innovative drug delivery mechanisms is expected to drive market expansion. Additionally, the increasing focus on generic drugs due to their cost-effectiveness is likely to boost the sales of drugs like TIMOPTIC, especially in developing economies[1].

Key Takeaways

  • The global ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030.
  • TIMOPTIC is a key player in the glaucoma treatment segment, known for its efficacy in reducing intraocular pressure.
  • Bausch Health, the company behind TIMOPTIC, has seen mixed financial results but remains a significant player in the ophthalmology segment.
  • The market is driven by advancements in drug delivery, rising prevalence of retinal disorders, and increasing investment in research and development.
  • Generic drugs, including those similar to TIMOPTIC, are expected to witness the fastest growth rate due to their cost-effectiveness.

FAQs

Q: What is the primary use of TIMOPTIC? A: TIMOPTIC is used to reduce elevated intraocular pressure, which is a major risk factor in the pathogenesis of glaucomatous visual field loss and optic nerve damage.

Q: How is the global ophthalmic drugs market expected to grow? A: The global ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030.

Q: Which segment dominates the ophthalmic drugs market? A: Anti-VEGF agents led the market in 2023, accounting for 32.71% of the global revenue.

Q: What are the key drivers of the ophthalmic drugs market? A: The key drivers include the rising prevalence of retinal disorders, advancements in drug delivery, and increasing investment in research and development.

Q: How does TIMOPTIC compare to other glaucoma treatments in terms of side effects? A: TIMOPTIC is generally well-tolerated and produces fewer and less severe side effects compared to other treatments like pilocarpine and epinephrine.

Sources

  1. Grand View Research - Ophthalmic Drugs Market Size & Share | Industry Report 2030
  2. Bausch Health - 4Q & FY 2021 - Financial Results - Bausch Health Companies Inc.
  3. Market Research Intellect - Tamaño y pronóstico del mercado de maleato de timolol
  4. Drugs.com - Timoptic: Package Insert / Prescribing Information
  5. Bausch Health - 4Q & FY 2020 - Financial Results - Bausch Health Companies Inc.

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