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Last Updated: December 22, 2024

CYCLOGYL Drug Patent Profile


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

Cyclogyl is a drug marketed by Alcon Labs Inc and is included in three NDAs.

The generic ingredient in CYCLOGYL is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.

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Drug patent expirations by year for CYCLOGYL
Drug Prices for CYCLOGYL

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Recent Clinical Trials for CYCLOGYL

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SponsorPhase
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePhase 4
Shanghai Eye Disease Prevention and Treatment CenterPhase 4
Pontificia Universidad Catolica de ChilePhase 4

See all CYCLOGYL clinical trials

US Patents and Regulatory Information for CYCLOGYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084109-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084110-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084108-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  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

CYCLOGYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cyclogyl (Cyclopentolate)

Overview of Cyclogyl

Cyclogyl, also known as cyclopentolate, is an anticholinergic medication used primarily to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscles) for diagnostic testing of the eye. It is a small molecule drug that blocks muscarinic receptors in the eye, leading to relaxation of the iris sphincter and ciliary muscles[1].

Market Share and Demand

The global market for cyclopentolate, including Cyclogyl, is characterized by a steady demand driven by the need for diagnostic eye examinations. The market is expected to grow moderately over the next few years, driven by increasing eye care needs and advancements in ophthalmic diagnostic techniques[4].

Competitive Landscape

Cyclogyl operates in a relatively stable market with a few key players. The competition is not highly intense due to the specific use case of the drug, which is primarily for diagnostic purposes. However, the presence of generic versions of cyclopentolate, such as those from Pharma Stulln Inc. and Bausch & Lomb Incorporated, does introduce some competition in the market[1].

Pricing Dynamics

The pricing of Cyclogyl and other cyclopentolate products is influenced by several factors, including production costs, market demand, and regulatory environments. Generally, the prices of these drugs are moderate, with variations depending on the concentration and brand. For instance, the prices range from approximately $0.71 to $12.99 per unit, depending on the formulation and brand[1].

Economic Implications of Drug Development

The development and pricing of drugs like Cyclogyl are part of a broader economic landscape influenced by research and development costs, patent protection, and generic competition. For small-molecule drugs like cyclopentolate, the expiration of patents typically leads to generic entry and subsequent price decreases. However, the specific market dynamics for ophthalmic diagnostic drugs may limit the impact of generic competition due to the specialized nature of these products[3].

Financial Performance of Manufacturers

Companies that manufacture Cyclogyl, such as Alcon Laboratories, Inc., operate within the broader pharmaceutical industry. Their financial performance is influenced by various factors including research and development expenses, marketing costs, and regulatory approvals.

For example, Alcon Laboratories, Inc., as part of Novartis, would report financials that include revenues and expenses related to Cyclogyl. While specific financial data for Cyclogyl alone might not be publicly available, the overall financial health of the company can provide insights into the drug's market performance.

Research and Development Expenses

The development of ophthalmic drugs, including those like Cyclogyl, involves significant research and development expenses. These costs are crucial for maintaining and improving the drug's efficacy and safety. Companies like Cyclo Therapeutics, although focused on different therapeutic areas, illustrate the importance of R&D investments in the pharmaceutical sector. For instance, Cyclo Therapeutics reported a decrease in R&D expenses in the first quarter of 2024, reflecting adjustments in project allocations and reductions in certain programs[2].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics and financial trajectory of drugs like Cyclogyl. Regulatory approvals and compliance with safety standards are essential for maintaining market presence. The drug has been approved in various regions, including the US, and its continued use is subject to ongoing regulatory oversight[1].

Market Trends and Future Outlook

The future outlook for Cyclogyl is influenced by several trends:

  • Increasing Demand for Eye Care: The growing need for diagnostic eye examinations due to an aging population and increasing prevalence of eye diseases is expected to drive demand for Cyclogyl.
  • Advancements in Diagnostic Techniques: Improvements in ophthalmic diagnostic tools and methods may enhance the utility and demand for cyclopentolate.
  • Generic Competition: The presence of generic versions of cyclopentolate will continue to influence pricing and market share.
  • Regulatory Changes: Any changes in regulatory policies or safety standards could impact the drug's market position.

Key Takeaways

  • Stable Market Demand: Cyclogyl operates in a market with steady demand driven by diagnostic eye examinations.
  • Moderate Pricing: Prices are influenced by production costs, market demand, and regulatory environments.
  • Limited Generic Competition: Despite generic versions, the specialized nature of the drug limits intense competition.
  • Regulatory Compliance: Ongoing regulatory oversight is crucial for market presence.
  • Future Trends: Increasing demand for eye care and advancements in diagnostic techniques will shape the future market.

FAQs

What is Cyclogyl used for?

Cyclogyl, or cyclopentolate, is used to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscles) for diagnostic testing of the eye.

Who are the key manufacturers of Cyclogyl?

Key manufacturers include Alcon Laboratories, Inc., Pharma Stulln Inc., and Bausch & Lomb Incorporated.

How does the pricing of Cyclogyl compare to other ophthalmic drugs?

The pricing of Cyclogyl is moderate, ranging from $0.71 to $12.99 per unit, depending on the formulation and brand.

What are the main factors influencing the market dynamics of Cyclogyl?

The main factors include demand for diagnostic eye examinations, presence of generic versions, regulatory environments, and advancements in ophthalmic diagnostic techniques.

How does the regulatory environment impact Cyclogyl?

Regulatory approvals and ongoing compliance with safety standards are essential for maintaining market presence and ensuring the drug's continued use.

What is the future outlook for Cyclogyl?

The future outlook is influenced by increasing demand for eye care, advancements in diagnostic techniques, and the presence of generic competition.

Sources

  1. DrugBank: Cyclopentolate: Uses, Interactions, Mechanism of Action.
  2. Cyclo Therapeutics: First Quarter 2024 Financial Results and Business Update.
  3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. Market Research Reports: Cyclopentolate - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.

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