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Last Updated: December 22, 2024

HALOTESTIN Drug Patent Profile


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

Halotestin is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in HALOTESTIN is fluoxymesterone. There are three drug master file entries for this compound. Additional details are available on the fluoxymesterone profile page.

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Summary for HALOTESTIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 48
Patent Applications: 4,900
DailyMed Link:HALOTESTIN at DailyMed
Drug patent expirations by year for HALOTESTIN

US Patents and Regulatory Information for HALOTESTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn HALOTESTIN fluoxymesterone TABLET;ORAL 010611-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn HALOTESTIN fluoxymesterone TABLET;ORAL 010611-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn HALOTESTIN fluoxymesterone TABLET;ORAL 010611-010 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

HALOTESTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Halotestin

Introduction

Halotestin, a brand name for the anabolic steroid fluoxymesterone, is used in various medical conditions, including male hypogonadism, delayed puberty, and certain types of breast cancer in women. Understanding the market dynamics and financial trajectory of Halotestin involves examining its clinical use, market position, and the financial performance of the companies involved in its production and distribution.

Clinical Use and Indications

Halotestin is indicated for replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone in males. This includes primary hypogonadism, hypogonadotropic hypogonadism, and delayed puberty. In females, it is used for the palliation of androgen-responsive recurrent mammary cancer[1][4].

Market Position

Halotestin is a prescription-only medication, which limits its market to patients with specific medical conditions. The demand for Halotestin is driven by the need for testosterone replacement therapy and the treatment of certain cancers. However, the market for anabolic steroids is highly regulated due to their potential for abuse and side effects.

Pharmaceutical Company Overview

Halotestin is not directly associated with the financial performance of any specific publicly traded company in the sources provided. However, understanding the broader pharmaceutical market can provide context.

Example: Halozyme's Financial Trajectory

While Halozyme (NASDAQ: HALO) is not the manufacturer of Halotestin, it is an example of a pharmaceutical company with a strong financial trajectory in the biopharmaceutical sector. Halozyme reported robust Q4 and FY 2023 financial growth, with a 26% year-over-year increase in total revenue to $829 million. The company projects continued growth, with revenue estimates ranging from $915 million to $985 million for 2024 and exceeding $1.5 billion by 2027 and 2028[2].

Financial Performance of Halotestin

Since Halotestin is not a product of a publicly traded company that has been highlighted in the sources, its specific financial performance is not readily available. However, here are some general points to consider:

Revenue Streams

  • The revenue generated by Halotestin would be part of the overall revenue of the pharmaceutical company that produces it. This revenue would come from prescription sales to patients with indicated conditions.
  • Given its niche market, the revenue from Halotestin is likely to be a fraction of the total revenue of the company.

Market Size and Growth

  • The market size for testosterone replacement therapy and anabolic steroids is significant but highly regulated. Growth in this market would depend on the prevalence of conditions requiring testosterone replacement and the approval of new indications.
  • The market is also influenced by the availability of alternative treatments and the regulatory environment.

Competitive Landscape

  • Halotestin competes with other testosterone replacement therapies and anabolic steroids. The competitive landscape includes both branded and generic products.
  • Companies in this space must navigate strict regulatory requirements and public health concerns related to the misuse of anabolic steroids.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Halotestin. Strict regulations govern the use and distribution of anabolic steroids due to their potential for abuse and side effects. Compliance with these regulations is essential for maintaining market presence.

Side Effects and Public Health Concerns

Halotestin, like other anabolic steroids, has significant side effects and potential health risks. These include liver toxicity, cardiovascular issues, and psychological effects. Public health concerns and the potential for misuse can impact demand and regulatory scrutiny[1][4].

Conclusion

Halotestin's market dynamics are influenced by its clinical use, regulatory environment, and the broader pharmaceutical market. While specific financial data for Halotestin is not available, understanding the general trends in the pharmaceutical industry and the regulatory landscape provides valuable context.

Key Takeaways

  • Halotestin is used for testosterone replacement therapy and certain medical conditions.
  • The market is regulated due to potential abuse and side effects.
  • Revenue streams are tied to prescription sales, and growth depends on the prevalence of indicated conditions.
  • The competitive landscape includes other testosterone replacement therapies and anabolic steroids.
  • Regulatory compliance is crucial for market presence.

FAQs

Q: What is Halotestin used for?

Halotestin is used for replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone in males and for the palliation of androgen-responsive recurrent mammary cancer in women[1][4].

Q: Is Halotestin a prescription-only medication?

Yes, Halotestin is a prescription-only medication due to its potential for abuse and side effects[1][4].

Q: How does the regulatory environment impact Halotestin?

The regulatory environment significantly impacts Halotestin by governing its use and distribution strictly due to its potential for abuse and side effects[1][4].

Q: What are the potential side effects of Halotestin?

Halotestin can have significant side effects, including liver toxicity, cardiovascular issues, and psychological effects[1][4].

Q: How does Halotestin compare to other testosterone replacement therapies?

Halotestin competes with other testosterone replacement therapies and anabolic steroids in the market. Its use is specific to certain medical conditions and is subject to strict regulatory oversight[1][4].

Sources

  1. Drugs.com: Halotestin: Package Insert / Prescribing Information.
  2. Investing.com: Halozyme reports robust Q4 and FY 2023 financial growth.
  3. Oregon.gov: BOARD MEETING AGENDA.
  4. Pharmacompass.com: Halotestin | Drug Information, Uses, Side Effects, Chemistry.

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