DANAZOL Drug Patent Profile

When do Danazol patents expire, and when can generic versions of Danazol launch?

Danazol is a drug marketed by Am Therap, Barr, and Lannett Co Inc. and is included in three NDAs.

The generic ingredient in DANAZOL is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Danazol

A generic version of DANAZOL was approved as danazol by BARR on August 9^th, 1996.

Summary for DANAZOL

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	52
Patent Applications:	5,257
Drug Prices:	Drug price information for DANAZOL
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
Chinese PLA General Hospital	Phase 2
Peking University Third Hospital	Phase 2
Beijing Tsinghua Changgeng 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
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
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582-001	Aug 9, 1996	AB	RX	No	Yes
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582-003	May 29, 1998	AB	RX	No	No
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582-002	May 29, 1998	AB	RX	No	No
Lannett Co Inc	DANAZOL	danazol	CAPSULE;ORAL	077246-003	Apr 19, 2007	AB	RX	No	No

Market Dynamics and Financial Trajectory for Danazol

Last updated: February 15, 2026

Overview of Danazol

Danazol is a synthetic androgen and progestin used primarily to treat endometriosis, fibrocystic breast disease, hereditary angioedema, and certain anemias. It was approved in the 1970s and remains on the market as a treatment option for specific conditions.

Regulatory Status and Patent Landscape

• Patents: Most patents for Danazol expired in the early 2000s. Several generic versions are available globally.
• Approvals: Approved by the U.S. Food and Drug Administration (FDA) in 1979; other agencies, including the European Medicines Agency (EMA), have similar approval timelines.
• Market exclusivity: No recent patent protections; generic competition is widespread.

Market Size and Key Drivers

• Global Market Value: Estimated at approximately $20 million to $50 million annually (2022–2023), driven mainly by off-label uses and limited licensed indications.
• Regional Markets:
  • North America: Dominates due to established prescribing habits for endometriosis and angioedema.
  • Europe: Similar to North America but with slower adoption for new indications.
  • Asia-Pacific: Market growing, influenced by increased awareness and access to generic formulations.
• Drivers:
  • Aging populations with endometriosis and hereditary angioedema.
  • Limited alternatives for specific off-label indications.
  • Generic drug proliferation reducing prices and expanding access.

Market Challenges

• Safety Concerns: Side effects include weight gain, hirsutism, and liver toxicity. Such concerns limit long-term use.
• Regulatory Restrictions: Warnings about virilization and hormone-related risks restrict use in specific populations.
• Competition: Availability of other hormonal treatments and newer therapies for endometriosis and angioedema.

Financial Trajectory

• Revenue Stability: Declining profit margins due to generic competition and safety concerns.
• Growth Potential:
  • Slight increase possible via niche indications, such as treatment-resistant angioedema.
  • Reformulation or new delivery methods could extend lifecycle.
• Profit Forecasts: Expected to decline at 2–4% CAGR over the next 5 years unless new indications or formulations are developed.

Market Entrants and Competition

• Generics dominate the landscape, with multiple pharmaceutical companies producing bioequivalent formulations.
• No recent patent filings or exclusivity grants aside from minor formulation patents.
• Competing products include danazol alternatives like danazol-like GnRH analogs, oral contraceptives, and anti-inflammatory agents.

Research and Development Trends

• Limited clinical research: Focus remains on optimizing existing formulations rather than new indications.
• Future prospects: Possible development of selective androgen receptor modulators (SARMs) that target similar pathways with fewer side effects.

Financial Impact of Healthcare Policies

• Pricing: Price reductions driven by generic competition lower revenues.
• Reimbursement policies: Tend to favor cost-effective generics over branded formulations.
• Regulatory pressures: Increasing safety warnings affect prescribing practices and market size.

Summary Table

Aspect	Details
Market Size (2023)	$20-$50 million
Main Regions	North America, Europe, Asia-Pacific
Patent Status	Patents expired, widespread generics
Revenue Trend	Declining at 2–4% CAGR
Key Drivers	Aging populations, niche indications, safety issues
Market Challenges	Safety concerns, regulatory restrictions, competition

Key Takeaways

• Danazol's traditional market is shrinking due to patent expiration and safety concerns.
• Generics dominate the sales landscape, suppressing prices and profit margins.
• Limited scope exists for growth via new indications; focus shifts toward optimizing formulations or targeted niche uses.
• Regulatory and safety issues constrain long-term market expansion.
• Future growth hinges on innovation, such as SARM development or new delivery systems.

FAQs

1. Are there any ongoing clinical trials for danazol?
   Few current trials focus on optimizing existing uses. Research into SARMs may indirectly impact danazol’s relevance.

2. What are the primary safety concerns associated with danazol?
   Liver toxicity, weight gain, virilization in women, and cardiovascular risks.

3. How does the availability of generics affect market potential?
   It lowers prices and reduces revenue for branded formulations, limiting incentives for manufacturers to invest in new development.

4. Could danazol regain market share with new indications?
   Unlikely without significant safety improvements or strong evidence from clinical studies demonstrating benefits over existing therapies.

5. What is the outlook for investors considering danazol-based products?
   Negative, unless new formulations or indications materialize that can justify higher pricing or market exclusivity.

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Sources

1. U.S. Food and Drug Administration. Drug Approval Database.
2. European Medicines Agency. Summary of Product Characteristics for Danazol.
3. Market research reports (e.g., GlobalData, IQVIA).
4. Clinical trial registries (e.g., ClinicalTrials.gov).
5. Peer-reviewed publications on danazol safety and efficacy.