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DROMOSTANOLONE PROPIONATE - Generic Drug Details
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What are the generic sources for dromostanolone propionate and what is the scope of patent protection?
Dromostanolone propionate
is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for dromostanolone propionate.
Summary for DROMOSTANOLONE PROPIONATE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| DailyMed Link: | DROMOSTANOLONE PROPIONATE at DailyMed |
US Patents and Regulatory Information for DROMOSTANOLONE PROPIONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | DROLBAN | dromostanolone propionate | INJECTABLE;INJECTION | 012936-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Dromostanolone Propionate
Introduction
Dromostanolone propionate, an androgenic anabolic steroid (AAS), holds a niche position within the pharmaceutical landscape primarily associated with therapeutic and performance-enhancing applications. While traditionally linked to testosterone analogs, its market trajectory is influenced by regulatory, medical, and societal factors. This analysis delineates the current market forces, understanding its financial landscape, and projecting future trends based on existing clinical, regulatory, and commercial data.
Pharmacological Profile and Therapeutic Use Cases
Dromostanolone propionate, chemically known as 17β-hydroxy-2α-methyl-5α-androstan-3-one 17β-propionate, exhibits strong androgenic properties with limited anabolic activity. Its primary applications historically included male hypogonadism, muscle wasting conditions, and off-label use for performance enhancement [1]. Due to its anabolic potency, it is often favored in conditions requiring androgen replacement therapy but faces constraints from side-effect profiles, including virilization and hepatotoxicity.
However, Dromostanolone propionate's use in mainstream clinical practice is marginal, overshadowed by more established agents like testosterone enanthate and testosterone propionate. Its utilization is further limited by regulatory status, with bans or restrictions in several jurisdictions due to misuse potential.
Regulatory Landscape and Market Barriers
In global markets, the regulatory environment heavily influences the drug's commercialization. The World Anti-Doping Agency (WADA) categorizes Dromostanolone as a prohibited substance, discouraging medical use for legitimate conditions and fostering illegal markets [2].
Furthermore, in developed markets such as the US and Europe, stringent FDA and EMA regulations restrict or prohibit its use in prescription medicines, compelling manufacturers to limit or withdraw offerings. The absence of broad approval harnesses limited commercial incentives and hampers investment into research and patent extensions. Conversely, certain emerging markets with lax regulatory enforcement may see sporadic use, but this remains a minor segment.
Market Demand: Therapeutic and Non-Therapeutic Sectors
Medical Demand:
Given its therapeutic profile, the demand for Dromostanolone propionate remains subdued. Its role is largely replaced by safer, better-characterized alternatives. The small niche of androgen replacement therapy favors drugs with improved safety profiles, pharmacokinetics, and patent protection, adversely affecting the market size for Dromostanolone propionate.
Performance-Enhancement and Illicit Markets:
The drug's anabolic properties contribute to its popularity within clandestine sports circles. The underground market revenue for anabolic steroids is estimated to be in the hundreds of millions, with Dromostanolone propionate representing a fraction of that business. This illicit activity skews demand but remains outside the scope of legitimate pharmaceutical markets and regulatory controls.
Competitive Landscape and Market Share
The anabolic steroid market is highly fragmented, with a handful of widely used agents like testosterone esters, nandrolone, and stanozolol dominating therapeutic and illicit use. Dromostanolone propionate’s share remains marginal, constrained by safety and regulatory concerns. It faces stiff competition from drugs with longer safety records, broader approval, and established manufacturing pipelines.
Key competitors include:
- Testosterone enanthate and cypionate
- Nandrolone decanoate
- Stanozolol
- Oxymetholone
Despite its potent androgenic effects, Dromostanolone propionate is unlikely to capture significant market share unless targeted at niche therapeutic areas or unless regulatory environments relax.
Pharmaceutical Industry Dynamics and Patent Landscape
The patent landscape for Dromostanolone propionate is sparse due to its age and the existence of numerous generic formulations. Its original patent protections have long expired, diminishing incentives for pharmaceutical innovation. Consequently, any prospective commercial activity hinges on reformulation, new delivery systems, or novel therapeutic indications—none currently prominent.
Industry trends favor the development of selective androgen receptor modulators (SARMs) and other targeted therapies with fewer side effects, further diminishing Dromostanolone propionate's relevance.
Financial Trajectory and Investment Outlook
Given the dubiously legal status, limited approved indications, and safety concerns, investment in Dromostanolone propionate remains low. The market for legitimate pharmaceutical products incorporating this compound is negligible, and the revenue generated from illicit channels is difficult to monetize legally.
Predictive analysis indicates:
- Short-term: Market stagnation, with minor niche use in research settings.
- Mid to Long-term: Decline in legitimate use due to regulatory crackdowns, with potential growth only in illicit markets, which are inaccessible to pharmaceutical investors.
Pharmaceutical firms have minimal financial incentives to develop or market Dromostanolone propionate, favoring alternative therapies with higher safety profiles, proven efficacy, and regulatory approval.
Emerging Trends and Future Outlook
Key Trends:
- Increasing regulation and drug scheduling restrict access.
- Evolution of safer, selective androgen receptor modulators diminishing demand for traditional steroids.
- Growing awareness of steroid abuse and anti-doping regulations suppress illegal markets.
Future Outlook:
The outlook for Dromostanolone propionate's legitimate market remains bleak. Unless a novel therapeutic application surfaces, supported by clinical evidence and regulatory approval, this compound is unlikely to see significant financial growth. The overall trend favors innovations in androgen therapy that are safer, targeted, and better tolerated, leaving traditional, hazardous steroids in the shadows.
Conclusion
Dromostanolone propionate's market dynamics are characterized by constrained therapeutic demand, regulatory restrictions, and competition from better-established compounds. Its financial trajectory is predominantly declining, with any residual demand restricted to underground markets, which are inaccessible to legal investors. The compound's future as a commercially viable pharmaceutical agent hinges on breakthroughs in safety, legal acceptance, or novel therapeutic indications, none of which are imminent.
Key Takeaways
- Limited Legitimate Market: Dromostanolone propionate's use in approved pharmaceuticals is minimal due to safety concerns and regulatory bans.
- Regulatory Hindrance: Stringent anti-doping and drug scheduling laws restrict both medical and illicit uses, constraining market growth.
- Competitive Disadvantage: The compound faces stiff competition from established steroids with better safety profiles and broader acceptance.
- Illicit Markets Impact: While illegal markets provide some demand, these are inaccessible to legitimate investors, limiting revenue prospects.
- Future Outlook: The compound's prospects are diminishing, with industry trends favoring safer, targeted androgen therapies, rendering Dromostanolone propionate a declining asset.
FAQs
-
Is Dromostanolone propionate approved for medical use globally?
No. Most regulatory agencies restrict or prohibit its medical use due to safety concerns and potential for misuse. -
What are the primary risks associated with Dromostanolone propionate?
Risks include virilization, liver toxicity, cardiovascular effects, and hormonal imbalances, which overshadow benefits. -
Can Dromostanolone propionate be legally prescribed or purchased?
In most jurisdictions, it cannot be legally prescribed; it is classified as a controlled substance or banned substance. -
Are there ongoing research efforts involving Dromostanolone propionate?
Limited research occurs, primarily in academic or clandestine contexts, with no significant clinical development programs. -
What are the alternatives to Dromostanolone propionate in androgen therapy?
Alternatives include testosterone esters, gels, pellets, and SARMs that are safer, legal, and better studied.
Sources:
[1] G. J. Ventresca, "Anabolic steroids: Pharmacology and clinical applications," Journal of Endocrinology, 2020.
[2] World Anti-Doping Agency, "Prohibited Substance List," 2022.
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