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Last Updated: December 22, 2024

Testosterone propionate - Generic Drug Details


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What are the generic sources for testosterone propionate and what is the scope of patent protection?

Testosterone propionate is the generic ingredient in one branded drug marketed by Bel Mar, Elkins Sinn, Lilly, and Watson Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for testosterone propionate.

Summary for testosterone propionate
Recent Clinical Trials for testosterone propionate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Texas at AustinPhase 4
University of Texas at AustinN/A
University of VermontPhase 1/Phase 2

See all testosterone propionate clinical trials

US Patents and Regulatory Information for testosterone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elkins Sinn TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080276-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080254-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080741-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 085490-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 085490-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080743-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TESTOSTERONE PROPIONATE testosterone propionate INJECTABLE;INJECTION 080188-001 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

Testosterone propionate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Testosterone Propionate

Introduction

Testosterone propionate, a synthetic androstane steroid derivative of testosterone, has been a part of the pharmaceutical landscape for several decades. However, its usage and market dynamics have evolved significantly over the years due to various factors.

Historical Context and Discontinuation

Testosterone propionate was initially developed and FDA-approved in 1974 but has since been discontinued for human use in many countries, including the United States. This discontinuation is largely due to the development of newer, longer-acting forms of testosterone that offer better safety profiles and require fewer injections[4].

Current Market Status

Despite its discontinuation for human use, testosterone propionate still finds applications in veterinary medicine, particularly in stimulating maximal growth in heifers[2].

Veterinary Market

In the veterinary sector, testosterone propionate continues to be used, although its market share is relatively small compared to other testosterone esters. The demand in this segment is stable but not growing significantly, as it is largely confined to specific veterinary applications.

Reasons for Decline in Human Use

Several factors have contributed to the decline of testosterone propionate in human medicine:

Short Half-Life

One of the primary reasons is its short half-life of approximately 4.5 days, which necessitates frequent injections to maintain adequate testosterone levels. This is in contrast to longer-acting forms like testosterone enanthate and testosterone cypionate, which require less frequent administration[4][5].

Safety and Efficacy

While testosterone propionate was not discontinued due to safety or efficacy concerns, the availability of newer forms with better safety profiles and convenience has made it less favorable. Newer forms like testosterone undecanoate and testosterone cypionate have become the mainstays of testosterone replacement therapy (TRT)[4].

Financial Trajectory

The financial trajectory of testosterone propionate is closely tied to its declining use in human medicine and limited use in veterinary applications.

Revenue Decline

The revenue generated from testosterone propionate has declined significantly since its discontinuation for human use. The market for testosterone replacement therapy is now dominated by other forms of testosterone, such as testosterone cypionate, testosterone enanthate, and testosterone undecanoate[3].

Market Size and Growth

The global testosterone replacement therapy market, which includes various forms of testosterone, is projected to grow from $1.9 billion in 2022 to $2.9 billion by 2032, with a CAGR of around 5%. However, testosterone propionate does not contribute significantly to this growth due to its limited use[3].

Regional Analysis

The regional dynamics of the testosterone replacement therapy market, which indirectly reflects the status of testosterone propionate, show that North America is the largest market, followed by Europe and Asia-Pacific. The Asia-Pacific region is expected to grow at the highest CAGR during the forecast period due to increasing incidence of hypogonadism and unhealthy lifestyles[3].

Competitive Analysis

The competitive landscape of the testosterone replacement therapy market is dominated by companies such as AbbVie Inc, Besins Healthcare SA, Acerus Pharmaceuticals Corporation, and Amneal Pharmaceuticals Inc. These companies focus on newer, more convenient, and safer forms of testosterone, further marginalizing testosterone propionate[3].

Market Trends and Drivers

The market trends in the testosterone replacement therapy sector are driven by factors such as the rising prevalence of hypogonadism, increasing geriatric population, and advancements in healthcare infrastructure. However, these trends do not favor the use of testosterone propionate due to its short half-life and the availability of better alternatives[3].

Conclusion

Testosterone propionate, once a part of the mainstream treatment for androgen deficiency, has largely been replaced by newer, longer-acting forms of testosterone. Its market dynamics are characterized by a decline in revenue and usage, limited to specific veterinary applications. The financial trajectory of this drug is thus marked by a significant reduction in its market share and revenue.

Key Takeaways

  • Testosterone propionate has been discontinued for human use in many countries due to the availability of better alternatives.
  • It is still used in veterinary medicine to stimulate growth in heifers.
  • The drug's short half-life and frequent injection requirement are major drawbacks.
  • The testosterone replacement therapy market is growing, but testosterone propionate does not contribute significantly to this growth.
  • Newer forms of testosterone dominate the market, driven by factors like safety, convenience, and efficacy.

FAQs

What is the primary reason for the discontinuation of testosterone propionate for human use?

The primary reason is the development of newer, longer-acting forms of testosterone that offer better safety profiles and require fewer injections.

Is testosterone propionate still used in any medical or veterinary applications?

Yes, it is still used in veterinary medicine to stimulate maximal growth in heifers.

What are the main drawbacks of testosterone propionate?

Its short half-life and the need for frequent injections are the main drawbacks.

Which regions are expected to dominate the testosterone replacement therapy market in the future?

North America currently dominates, but the Asia-Pacific region is expected to grow at the highest CAGR during the forecast period.

What are the key drivers of the testosterone replacement therapy market?

The rising prevalence of hypogonadism, increasing geriatric population, and advancements in healthcare infrastructure are key drivers.

Sources

  1. Cognitivemarketresearch.com: Testosterone Propionate Market Report 2024 (Global Edition)
  2. DrugBank: Testosterone propionate: Uses, Interactions, Mechanism of Action
  3. Alliedmarketresearch.com: Testosterone Replacement Therapy Market Size Report, 2032
  4. Ro.co: Testosterone Propionate: Why Isn’t It Used Anymore?
  5. Wikipedia: Testosterone propionate

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