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Last Updated: December 28, 2024

CYSTARAN Drug Patent Profile


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Which patents cover Cystaran, and when can generic versions of Cystaran launch?

Cystaran is a drug marketed by Leadiant Biosci Inc and is included in one NDA.

The generic ingredient in CYSTARAN is cysteamine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine hydrochloride profile page.

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

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Pharmacology for CYSTARAN

US Patents and Regulatory Information for CYSTARAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leadiant Biosci Inc CYSTARAN cysteamine hydrochloride SOLUTION/DROPS;OPHTHALMIC 200740-001 Oct 2, 2012 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

CYSTARAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CYSTARAN

Introduction to CYSTARAN

CYSTARAN (cysteamine ophthalmic solution) is a cystine-depleting agent specifically designed for the treatment of corneal cystine crystal accumulation in patients with cystinosis. This condition is a rare genetic disorder characterized by the accumulation of cystine within cells, leading to various systemic and ocular complications.

Market Size and Growth

The cystinosis market, which includes treatments like CYSTARAN, has been experiencing significant growth. As of 2017, the total market size of cystinosis in seven major markets was valued at USD 130.46 million, with the United States accounting for the largest share at USD 86.52 million[1][4].

Projected Growth

The market is expected to increase at a significant Compound Annual Growth Rate (CAGR) during the forecast period of 2017-2028. This growth is driven by the increasing demand for effective treatments and the introduction of new therapies, including CYSTARAN[1][4].

Key Drivers of Market Growth

Innovations in Drug Treatments

CYSTARAN, along with other cysteamine-based treatments like Cystadrops and Cystagon, has revolutionized the management of cystinosis. These drugs reduce cystine accumulation, thereby improving patient outcomes and driving market growth[3].

Increasing Awareness and Early Diagnosis

Growing awareness among healthcare professionals and patients about cystinosis has led to earlier diagnoses and better management of the disease. This increased awareness contributes to a higher demand for treatments like CYSTARAN[3].

Technological Advancements

Advancements in medication delivery, such as the development of extended-release formulations, improve patient compliance and management of the condition. These innovations are crucial for the sustained growth of the market[3].

Competitive Landscape

Market Competition

CYSTARAN is marketed in the US for the treatment of ocular cystinosis, while Cystadrops, another cysteamine-based therapy, is approved in Europe and has been filed for approval in the US. This could potentially create competition for CYSTARAN in the US market once Cystadrops is approved[4].

Emerging Therapies

Other emerging therapies, such as AVR-RD-04 (a lentiviral-based gene therapy) and ELX-02 (a ribosomal protein modulator), are also expected to impact the market dynamics. These new treatments may offer alternative mechanisms of action and could compete with existing therapies like CYSTARAN[1][4].

Financial Trajectory

Current Market Contribution

The current market size of cystinosis treatments, including CYSTARAN, is significant. In 2017, the market size attributed to these treatments was substantial, with CYSTARAN contributing to the overall growth due to its efficacy in treating ocular cystinosis[1][4].

Projected Revenue

The nephropathic cystinosis treatment market, which includes ocular treatments like CYSTARAN, is projected to reach over USD 744 million by 2034, up from USD 332.5 million in 2023. This growth indicates a promising financial trajectory for CYSTARAN and similar treatments[3].

Market Outlook: Regional Analysis

United States

The US market accounts for the highest share of the cystinosis treatment market. CYSTARAN, being approved and marketed in the US, benefits from this large market size and is expected to continue contributing significantly to the overall revenue[1][4].

EU5 and Other Regions

In Europe, while Cystadrops is currently approved, CYSTARAN's presence in the US and potential expansion into other regions could further boost its market share. The global reach and increasing awareness in regions like Japan, Asia Pacific, and Latin America also contribute to the market's expansion[1][3].

Challenges and Opportunities

High Cost of Treatment

One of the challenges facing CYSTARAN and other cystinosis treatments is the high cost of therapy. This can limit access to treatment, especially in regions with limited healthcare resources[3].

Technological Innovations

Despite the challenges, continuous advancements in gene therapy and personalized medicine offer new avenues for treating cystinosis. These innovations could lead to more effective and long-term solutions, further driving the market growth[3].

Key Takeaways

  • Market Growth: The cystinosis treatment market, including CYSTARAN, is expected to grow significantly due to innovations in drug treatments and increasing awareness.
  • Competitive Landscape: CYSTARAN faces competition from other cysteamine-based treatments and emerging therapies.
  • Financial Trajectory: The market is projected to reach over USD 744 million by 2034, indicating a strong financial outlook for CYSTARAN.
  • Regional Analysis: The US market is the largest contributor, with potential for growth in other regions.
  • Challenges and Opportunities: High treatment costs are a challenge, but technological innovations offer significant opportunities.

FAQs

What is CYSTARAN used for?

CYSTARAN is used for the treatment of corneal cystine crystal accumulation in patients with cystinosis, a rare genetic disorder[2].

How does CYSTARAN work?

CYSTARAN works by depleting lysosomal cystine, preventing the buildup of cystine crystals in bodily tissues. It interacts with cystine to form substances that can be eliminated from the cell[2].

What is the current market size of cystinosis treatments?

As of 2017, the total market size of cystinosis treatments in seven major markets was USD 130.46 million[1][4].

What are the key drivers of market growth for CYSTARAN?

Key drivers include innovations in drug treatments, increasing awareness and early diagnosis, and technological advancements in medication delivery[3].

What are the potential challenges for CYSTARAN in the market?

Challenges include competition from other treatments, high treatment costs, and the need for further clinical trials to validate new therapies[3].

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