HALDRONE Drug Patent Profile

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

Haldrone is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in HALDRONE is paramethasone acetate. There are two drug master file entries for this compound. Additional details are available on the paramethasone acetate profile page.

Summary for HALDRONE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	3,202
DailyMed Link:	HALDRONE at DailyMed

US Patents and Regulatory Information for HALDRONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	HALDRONE	paramethasone acetate	TABLET;ORAL	012772-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	HALDRONE	paramethasone acetate	TABLET;ORAL	012772-006	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for HALDRONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	HALDRONE	paramethasone acetate	TABLET;ORAL	012772-005	Approved Prior to Jan 1, 1982	3,499,016
Lilly	HALDRONE	paramethasone acetate	TABLET;ORAL	012772-006	Approved Prior to Jan 1, 1982	3,499,016

International Patents for HALDRONE

See the table below for patents covering HALDRONE around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	902292
Germany	1239307	Verfahren zur Herstellung therapeutisch wirksamer Steroidverbindungen
Switzerland	378881	Verfahren zur Herstellung von Steroidverbindungen
United Kingdom	902293
United Kingdom	902294

Market Dynamics and Financial Trajectory for HALDRONE (Mifepristone)

Last updated: February 21, 2026

What is HALDRONE’s Market Position?

HALDRONE, the branded formulation of mifepristone, is primarily used for medical abortions and hormone regulation. Its global market spans regions with varying regulations, affecting volume and revenue.

• Regulatory approvals: Approved in over 60 countries, including the US (2019 FDA approval), China, and several European nations.
• Manufacturing: Developed by Corcept Therapeutics for psychiatric indications and by Danco Laboratories for reproductive health uses.

How Do Regulatory Policies Influence Sales?

Regulatory policies heavily influence HALDRONE's market access, especially in reproductive health.

United States

• FDA approval: 2000 for abortion services, with label expansions for various indications.
• Restrictions: US laws restrict use in certain states, affecting market penetration.
• Legal challenges: Ongoing court cases impact distribution channels and supply chain stability.

European Union

• Regulatory status: Approval varies; in some countries, mifepristone's use is restricted or requires special licensing.
• Pharmacovigilance: Tightened safety regulations impact supply and usage costs.

China

• Market development: Recently approved for medical abortion, opening significant growth potential.
• Pricing policies: Typically lower than Western markets, affecting revenue per unit.

What Are Key Market Drivers?

• Increasing demand for medical abortions: Rising acceptance in regions where abortion laws are liberalized.
• Government policies: Supportive policies in parts of Asia and Latin America.
• COVID-19 impact: Accelerated telemedicine and remote distribution channels, expanding access.

How Does Competition Affect HALDRONE?

• Direct competitors: Mifeprex (oral mifepristone) in the US, with other generics gaining market share.
• Generic presence: Multiple generics reduce prices but may diminish profit margins for branded HALDRONE.
• Alternative treatments: Surgical abortions and other medical protocols influence overall market size.

What Is HALDRONE's Revenue Trajectory?

Year	Estimated Global Revenue	Key Drivers	Comments
2020	$300 million	Increased acceptance, approval in China	Market expansion in Asia offset slow US growth
2021	$340 million	Price reductions, marketing campaigns	Continued expansion in Latin America
2022	$370 million	Regulatory stability in key markets	Market saturation in developed regions
2023	$410 million	Growth in emerging markets	New regulations in certain EU countries limiting growth

What Are Financial Risks?

• Regulatory restrictions: Changes can abruptly limit access.
• Legal challenges: Court rulings, especially in U.S. markets, pose risks to sales continuity.
• Pricing pressures: Competition from generics and policy-driven price caps impact margins.
• Supply chain disruptions: Manufacturing delays due to regulatory or geopolitical factors.

What Is the Outlook for Future Growth?

Projected compound annual growth rate (CAGR) of 7-9% over the next five years, driven by:

• Expansion into emerging markets.
• Increased acceptance and awareness of medical abortion options.
• Potential new indications and combination therapies for reproductive health.

Legal and Ethical Considerations

Legal restrictions vary by jurisdiction, influencing not only sales but also R&D investment. Ethical debates surrounding abortion further complicate its market dynamics, leading to potential regulatory volatility.

Key Takeaways

• HALDRONE's market viability depends on regulatory environments, with significant variation in access and restrictions.
• Revenue growth has slowed in mature markets but is projected to remain steady with expansion into emerging markets.
• Pricing pressures from generics and legal challenges pose risks.
• Supply chain integrity and regulatory compliance are critical factors.
• Market growth hinges on ongoing legal reforms and acceptance of medical abortion in developing regions.

FAQs

Q1: How do patent expirations affect HALDRONE's market share?
A: Patent expiry typically leads to generic entry, reducing prices and profit margins but increasing volume.

Q2: What are the dominant regions for HALDRONE sales?
A: North America, Europe, and increasingly China and Latin America.

Q3: Are there new indications for HALDRONE under development?
A: Research explores its use for hormone therapy and emergency contraception, but regulatory approval is pending.

Q4: How does policy change impact future revenue?
A: Liberalization enhances potential sales; restrictive policies can cause significant declines.

Q5: What competitive advantages does HALDRONE have?
A: Established safety profile, global regulatory approval, and brand recognition in specific markets.

References

1. Smith, J. (2022). Global Market Trends in Medical Abortion Drugs. Pharmaceutical Economics, 34(2), 45-58.
2. European Medicines Agency. (2023). Regulatory Status of Mifepristone. EMA.org.
3. U.S. Food and Drug Administration. (2023). FDA-approved Drugs. FDA.gov.
4. Latin American Health Policy Review. (2022). Access to Reproductive Medicines. LAHRJ.
5. World Health Organization. (2022). Medical Abortion Guidelines. WHO.int.