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Last Updated: December 22, 2024

THEELIN Drug Patent Profile


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Which patents cover Theelin, and what generic alternatives are available?

Theelin is a drug marketed by Parkedale and is included in one NDA.

The generic ingredient in THEELIN is estrone. There are nine drug master file entries for this compound. Additional details are available on the estrone profile page.

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Summary for THEELIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 106
Patent Applications: 3,514
DailyMed Link:THEELIN at DailyMed
Drug patent expirations by year for THEELIN

US Patents and Regulatory Information for THEELIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-003 Approved Prior to Jan 1, 1982 DISCN No 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

THEELIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estrone (Theelin)

Introduction

Estrone, marketed under various brand names including Theelin, is an estrogen medication and a naturally occurring steroid hormone. It is widely used in hormone replacement therapy (HRT) to address symptoms associated with menopause and other estrogen deficiency conditions. Here, we will delve into the market dynamics and financial trajectory of estrone, focusing on its usage, market trends, and economic implications.

Clinical Uses and Indications

Estrone is primarily used to treat symptoms of menopause, such as hot flashes and vaginal dryness, and to prevent osteoporosis in post-menopausal women[2][5].

Market Size and Growth

The global pharmaceutical market, which includes estrogen therapies like estrone, is projected to grow significantly. By 2024, the global pharmaceutical market revenue is expected to reach $1.15 trillion and is forecasted to exceed $1.4 trillion by 2028. This growth is driven by the increasing global burden of chronic diseases, including those affecting menopausal women[3].

Regional Market Analysis

The demand for estrogen therapies varies by region. For instance, sales data for conjugated estrogens, which include estrone, show significant variations across different regions. In North America, the sales of conjugated estrogens were substantial, with over 217,000 standard units sold in 2004. In contrast, regions like Africa and South-East Asia had much lower sales figures, indicating a need for expanded market penetration in these areas[4].

Competitive Landscape

The market for estrogen therapies is competitive, with several products available, including conjugated estrogens and other forms of estrogen like estradiol. Estrone is sold under various brand names, such as Estragyn, Kestrin, and Theelin, each with its own market share and customer base. The presence of generic and biosimilar versions of these drugs also influences the competitive landscape, as they can significantly reduce the market share of brand-name drugs once patent exclusivity is lost[2][3].

Financial Trajectory

Development and Production Costs

The development of new drugs, including hormone therapies like estrone, is a costly and time-consuming process. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. However, estrone, being an established medication, does not incur these initial development costs. Instead, its financial trajectory is influenced by production, marketing, and regulatory compliance costs[3].

Revenue and Sales

Estrone generates significant revenue, particularly in regions with high demand for HRT. The sales figures for conjugated estrogens, which include estrone, indicate a substantial market presence. For example, in North America, the sales of conjugated estrogens were over 217,000 standard units in 2004, reflecting a robust market[4].

Pricing and Profitability

The pricing of estrone varies depending on the dosage form and region. For instance, estrone powder and crystal forms have different price points, with the powder costing around $21.42 per gram and the crystal form costing around $11.76 per gram[2].

Return on Investment (ROI)

The ROI for pharmaceutical R&D has been declining in recent years, partly due to increasing regulatory costs and shorter exclusivity periods. However, established drugs like estrone, which have already recouped their development costs, can maintain a more stable ROI. The financial sustainability of estrone is supported by its long-standing presence in the market and its continued demand[3].

Regulatory and Patent Landscape

Estrone, as an established medication, is no longer under patent protection. This allows for the production of generic versions, which can impact the sales of brand-name products. However, the continued demand for HRT ensures that estrone remains a viable product in the market. Regulatory compliance remains crucial, as changes in guidelines or safety concerns can affect the drug's market position[2][3].

Market Trends and Future Outlook

Growing Demand for HRT

The increasing global population of menopausal women drives the demand for HRT, including estrone. This demographic trend is expected to continue, ensuring a steady market for estrogen therapies[3].

Innovations in Delivery Systems

Advancements in delivery systems, such as vaginal creams and suppositories, enhance the efficacy and patient compliance of estrone. These innovations can help maintain or even increase market share by offering more convenient and effective treatment options[2].

Competitive Pressures

The introduction of new drugs and therapies, including biosimilars and generic versions, poses a competitive challenge to brand-name estrone products. However, the established brand reputation and ongoing demand for HRT help mitigate these pressures[3].

Key Takeaways

  • Market Growth: The global pharmaceutical market, including estrogen therapies like estrone, is projected to grow significantly.
  • Regional Variations: Demand for estrone varies by region, with North America showing higher sales figures.
  • Competitive Landscape: The market is competitive, with generic and biosimilar versions impacting brand-name sales.
  • Financial Trajectory: Estrone generates significant revenue, with stable ROI due to its established market presence.
  • Regulatory and Patent Landscape: Generic production is possible due to the lack of patent protection, but regulatory compliance is crucial.
  • Market Trends: Growing demand for HRT and innovations in delivery systems support the future outlook for estrone.

FAQs

What is estrone used for?

Estrone is used primarily for hormone replacement therapy (HRT) to treat symptoms of menopause, such as hot flashes and vaginal dryness, and to prevent osteoporosis in post-menopausal women.

How is estrone administered?

Estrone can be administered via various routes, including intramuscular injection, vaginal creams or suppositories, and orally as estrone sulfate.

What are the common brand names for estrone?

Estrone is sold under several brand names, including Estragyn, Kestrin, and Theelin.

What are the potential side effects of estrone?

Common side effects include breast tenderness, nausea, and changes in menstrual flow. Serious side effects can include increased risk of blood clots and certain cancers.

How does the market for estrone compare to other estrogen therapies?

The market for estrone is part of the broader estrogen therapy market, which includes other forms of estrogen like estradiol. Estrone competes with these products but maintains a significant market share due to its established use and brand recognition.

Sources

  1. Wikipedia: Estrone (medication)
  2. DrugBank: Estrone: Uses, Interactions, Mechanism of Action
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research
  4. IARC Publications: Annex 1 - IARC Publications
  5. PharmaCompass: Esterone | Drug Information, Uses, Side Effects, Pharma ...

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