DANAZOL - Generic Drug Details

What are the generic drug sources for danazol and what is the scope of freedom to operate?

Danazol is the generic ingredient in two branded drugs marketed by Am Therap, Barr, Lannett Co Inc, and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for danazol. Four suppliers are listed for this compound.

Summary for DANAZOL

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	51
Patent Applications:	5,723
Drug Prices:	Drug price trends for DANAZOL
What excipients (inactive ingredients) are in DANAZOL?	DANAZOL excipients list
DailyMed Link:	DANAZOL at DailyMed

See drug prices for DANAZOL

Recent Clinical Trials for DANAZOL

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

Sponsor	Phase
Peking University First Hospital	Phase 2
Beijing Luhe Hospital	Phase 2
Chinese PLA General Hospital	Phase 2

See all DANAZOL clinical trials

Pharmacology for DANAZOL

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for DANAZOL

Estrogen Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DANAZOL

G03XA	Antigonadotropins and similar agents
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for DANAZOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582-001	Aug 9, 1996	AB	RX	No	Yes
Lannett Co Inc	DANAZOL	danazol	CAPSULE;ORAL	077246-002	Apr 19, 2007	AB	RX	No	No
Am Therap	DANAZOL	danazol	CAPSULE;ORAL	071569-001	Dec 30, 1987		DISCN	No	No
Lannett Co Inc	DANAZOL	danazol	CAPSULE;ORAL	077246-001	Sep 28, 2005	AB	RX	No	No

DANAZOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Danazol

Introduction to Danazol

Danazol is a synthetic steroid that has been widely used in the medical field for various indications, including gynecological and hematological conditions. Understanding the market dynamics and financial trajectory of danazol is crucial for pharmaceutical companies, investors, and healthcare professionals.

Historical and Current Market Size

The global danazol market has shown significant growth in recent years. As of 2023, the global danazol market size was substantial, with a compound annual growth rate (CAGR) projected to be around 6% from 2024 to 2031[4].

Market Segmentation

The danazol market is segmented based on type and application. The purity of danazol, particularly the 98% purity segment, accounted for a noticeable share of the global market in 2023 and is expected to experience significant growth in the near future. The oral form of danazol is also anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[1].

Key Applications and Indications

Danazol is primarily used for managing endometriosis, uterine fibroids, fibrocystic breast disease, and heavy menstrual bleeding. It has demonstrated greater effectiveness than other medical therapies such as progestogens, NSAIDs, and OCPs for these conditions. Additionally, danazol has been explored for its efficacy in various hematologic diseases, including persistent/chronic refractory immune thrombocytopenia (ITP), amegakaryocytic thrombocytopenic purpura, paroxysmal nocturnal hemoglobinuria, myelofibrosis, and Diamond-Blackfan anemia[3].

FDA-Approved Indications

• Mild and Moderate to Severe Endometriosis
• Hereditary Angioedema

Off-Label Uses

• Fibrocystic Breast Disease
• Thromboembolic and Thrombophlebitic Events
• Acquired Amegakaryocytic Thrombocytopenic Purpura
• Immune Thrombocytopenia Purpura
• Chronic Lymphocytic Leukemia

Market Drivers

Several factors drive the growth of the danazol market:

Increasing Prevalence of Gynecological and Hematological Disorders

The rising incidence of endometriosis, uterine fibroids, and other gynecological conditions, along with hematological diseases, contributes to the demand for danazol.

Efficacy and Safety Profile

Danazol's relatively safer adverse effect profile compared to conventional steroids and its efficacy in treatment-resistant cases make it a preferred choice among clinicians[3].

Cost-Effectiveness

Danazol is an inexpensive and readily available drug, which is a significant factor in its market growth, especially in regions with limited healthcare budgets.

Market Restraints

Despite its growth, the danazol market faces several restraints:

Adverse Effects

Danazol can cause various side effects, including elevated concentrations of hepatic enzymes, jaundice, decreased HDL, and increased LDL. It also has the potential to interfere with laboratory measurements of androgens and can cause rhabdomyolysis when used concurrently with statins[3].

Regulatory Challenges

Changes in regulatory environments and safety regulations can impact the production, pricing, and distribution of danazol.

Regional Analysis

The danazol market varies significantly across different regions due to factors such as raw material availability, regulatory environments, and healthcare infrastructure. The market is segmented into major regions including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its unique market size, share, and growth prospects[1].

Competitive Landscape

The danazol market is competitive, with several key players focusing on strategy building to strengthen their product portfolios and expand their business globally. Companies like Bayer and AMRI are prominent in this market, continuously working to improve their market share and customer satisfaction[1].

Financial Performance and Projections

While the financial performance of companies specifically producing danazol is not detailed in the available sources, the overall pharmaceutical sector trends can provide insights. For instance, the projected CAGR of around 6% indicates a steady financial growth trajectory for the danazol market. Here are some key financial metrics:

• Market Size and Growth Rate: The global danazol market is expected to grow at a CAGR of around 6% from 2024 to 2031[4].
• Revenue and Sales: The market size in 2023 was substantial, and the forecast period from 2025 to 2031 is expected to see continued growth[1].

Technological and Regulatory Trends

Technological Advancements

Recent advances in medicine have introduced more effective treatments for endometriosis, but danazol remains valuable for treatment-resistant cases. Technological advancements in manufacturing processes and the development of new formulations could further enhance the market[3].

Regulatory and Safety Considerations

Environmental and safety regulations play a crucial role in shaping the chemical and pharmaceutical industries. Compliance with these regulations is essential for the continued production and distribution of danazol[1].

Consumer Behavior and Preferences

Consumer behavior is influenced by the efficacy, safety, and cost-effectiveness of danazol. Patients and clinicians prefer danazol due to its relatively safer profile and effectiveness in managing various gynecological and hematological conditions.

Key Takeaways

• Growing Demand: The danazol market is experiencing significant growth driven by the increasing prevalence of gynecological and hematological disorders.
• Efficacy and Safety: Danazol's relatively safer adverse effect profile and efficacy in treatment-resistant cases are key drivers.
• Regional Variations: Market dynamics vary across regions due to different regulatory environments and healthcare infrastructures.
• Competitive Landscape: The market is competitive, with key players focusing on strategy building and product portfolio enhancement.
• Financial Projections: The market is projected to grow at a CAGR of around 6% from 2024 to 2031.

FAQs

What are the primary indications for danazol?

Danazol is primarily used for managing endometriosis, uterine fibroids, fibrocystic breast disease, and heavy menstrual bleeding. It also has off-label uses in various hematologic diseases.

What are the potential side effects of danazol?

Danazol can cause elevated concentrations of hepatic enzymes, jaundice, decreased HDL, and increased LDL. It can also interfere with laboratory measurements of androgens and cause rhabdomyolysis when used with statins.

How is the danazol market segmented?

The danazol market is segmented based on type (purity levels) and application (oral and other forms).

What is the projected growth rate of the danazol market?

The global danazol market is expected to grow at a compound annual growth rate (CAGR) of around 6% from 2024 to 2031.

Which companies are key players in the danazol market?

Companies like Bayer and AMRI are prominent players in the danazol market, focusing on strategy building and product portfolio enhancement.

Sources

1. Cognitivemarketresearch.com: Danazol Market Report 2024 (Global Edition)
2. Dana.com: Dana Incorporated Reports 2024 First-Quarter Financial Results
3. NCBI Bookshelf: Danazol - StatPearls
4. Marketresearchintellect.com: Danazol Market Size And Projection