MIFEPREX Drug Patent Profile

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

Mifeprex is a drug marketed by Danco Labs Llc and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mifeprex

A generic version of MIFEPREX was approved as mifepristone by GENBIOPRO on April 11^th, 2019.

Summary for MIFEPREX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	25
What excipients (inactive ingredients) are in MIFEPREX?	MIFEPREX excipients list
DailyMed Link:	MIFEPREX at DailyMed

Recent Clinical Trials for MIFEPREX

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

Sponsor	Phase
RTI International	Phase 1
Rochester General Hospital	Phase 1
Nova Southeastern University	Phase 1

See all MIFEPREX clinical trials

US Patents and Regulatory Information for MIFEPREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	AB	RX	Yes	Yes

Expired US Patents for MIFEPREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000

International Patents for MIFEPREX

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

Country	Patent Number	Title	Estimated Expiration
Japan	2785023
Israel	65680	11BETA SUBSTITUTED STEROIDS,PROCESS FOR PREPARING THEM,MEDICAMENTS AND COMPOSITIONS CONTAINING THEM
Canada	1193246	PROCEDE DE PREPARATION DE NOUVEAUX DERIVES STEROIDES SUBSTITUES EN 11 .beta. (PROCEDE DE PREPARATION DE NOUVEAUX DERIVES STEROIDES SUBSTITUES EN 11 (BETA))
Hungary	185158	PROCESS FOR THE PREPARATION OF BETA-SUBSTITUTED STEROIDE DERIVATIVES
South Africa	8408003
Canada	1220780	PROCEDE DE PREPARATION DE NOUVEAUX 19-NOR STEROIDES SUBSTITUES EN 11.beta. ET EVENTUELLEMENT EN 2 (PROCESS FOR THE PREPARATION OF NEW 19-NOR STEROIDS SUBSTITUDED IN THE POSITION 11B AND EVENTUALLY 2)
South Korea	840000581

Supplementary Protection Certificates for MIFEPREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0057115	SPC/GB93/030	United Kingdom

Market Dynamics and Financial Trajectory for Mifeprex

Last updated: July 29, 2025

Introduction

Mifeprex, the brand name for mifepristone, is a pharmaceutical agent primarily used for medical termination of early pregnancy. Since its approval by the U.S. Food and Drug Administration (FDA) in 2000, Mifeprex has played a significant role in reproductive health, also serving applications in Cushing’s syndrome management. The evolving legal, regulatory, social, and technological landscapes continually influence its market dynamics and financial trajectory. This analysis explores the factors shaping the current and future market for Mifeprex, offering strategic insights into its commercial prospects.

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Regulatory and Legal Environment

FDA Approval and Regulations

Mifeprex received FDA approval in 2000 under the Medical Management of Abortion protocol, marketed as part of the FDA-approved regimen involving mifepristone and misoprostol. The FDA instituted risk management programs, including the REMS (Risk Evaluation and Mitigation Strategy), to ensure safe access [1]. Regulatory frameworks have historically impacted prescribing practices and distribution channels.

Recent regulatory amendments in 2016 aimed to simplify access—allowing for office administration (instead of clinics) and eliminating the requirement for in-person dispensing under certain conditions. These changes expanded access, particularly during the COVID-19 pandemic when telemedicine became a pivotal modality.

Legislative Developments

The legal landscape is highly dynamic. Several states have enacted restrictions or outright bans on medication abortion, directly impacting Mifeprex sales. Conversely, federal courts have issued rulings safeguarding access, reflecting ongoing legal debates over abortion rights. The overturning of Roe v. Wade in 2022 notably shifted legal authority to states, creating a fragmented environment that influences market size, sales volume, and distribution logistics.

Global Regulatory Perspectives

Internationally, approvals vary; while some countries recognize mifepristone for medical abortion, others impose bans or restrictive measures. Navigating these diverse regulatory settings impacts growth strategies for pharmaceutical companies and affects potential revenue streams globally.

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Market Size and Demand Drivers

Reproductive Health and Abortion Services

Mifeprex is a cornerstone in medical abortion, offering a non-invasive alternative to surgical procedures. Estimates indicate that, in the United States alone, approximately 1 in 4 abortions are performed medically [2]. The demand is influenced by factors such as:

• Legal and regulatory access: Changes in legislation directly impact prescribing rates.
• Population demographics: Growing awareness and access among younger populations fuel demand.
• Technological innovations: Telemedicine models facilitate broader access, especially in underserved areas.
• Pandemic-related disruptions: COVID-19 accelerated telehealth adoption, increasing Mifeprex utilization outside traditional clinical settings.

Cushing’s Syndrome Treatment

Beyond reproductive health, off-label use of Mifeprex for controlling hypercortisolism in Cushing’s syndrome presents a supplementary market segment. While smaller, it offers additional revenue channels.

Market Penetration and Competition

The medical abortion market faces competition from surgical methods; however, Mifeprex’s non-invasive convenience, coupled with preference shifts toward private and outpatient settings, sustains its demand. Biosimilar and generic formulations introduce pricing pressures, yet patent protections and formulations' stability support brand loyalty and revenue retention.

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Competitive Landscape

Main Competitors and Alternatives

The primary competition stems from other medical abortion regimens involving misoprostol alone or in combination with alternative agents. Surgical alternatives, such as vacuum aspiration, remain prevalent, especially where regulatory or social barriers constrain pharmaceutical access.

Biosimilar and Generic Entry

The expiration of initial patents typically invites generic manufacturers, fostering price competition. However, stringent REMS requirements and manufacturing complexities mitigate immediate commoditization risks, allowing brand owners to sustain premium pricing initially.

Emerging Technologies

Advancements in drug delivery systems, telemedicine, and digital health integration are redefining how Mifeprex is prescribed and administered, potentially influencing market share dynamics.

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Financial Trajectory and Revenue Outlook

Historical Performance

Post-FDA approval, Mifeprex experienced steady growth driven by increasing acceptance, expanding access, and broader legislations. Sales peaked in the mid-2010s before plateauing amid regulatory hurdles and social debates.

Projected Growth Factors

• Regulatory Liberalization or Further Restrictions: Easing access, as seen with recent FDA modifications, supports revenue growth. Conversely, state-level bans threaten market contraction.
• Telemedicine Adoption: Aided by the COVID-19 pandemic, telemedicine-prescribed Mifeprex expands reach, potentially doubling or tripling sales volumes.
• Global Expansion: Entry into emerging markets with unmet reproductive health needs offers substantial upside, provided regulatory pathways are navigated effectively.
• Pricing Strategies: Premium pricing during patent exclusivity will persist until biosimilars gain approval; post-patent expiration, pricing pressures will intensify.

Risks and Challenges

Legal battles, societal opposition, and ethical debates pose risks to revenue stability. Additionally, supply chain disruptions and regulatory bottlenecks could delay access and sales growth.

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Market Opportunities and Strategic Outlook

Policy Advocacy and Stakeholder Engagement

Active engagement with policymakers and healthcare providers can mitigate legal risks, promote awareness, and facilitate access programs.

Leveraging Digital Health

Investing in telehealth infrastructure and patient education platforms will enable broader outreach, especially in conservative or remote regions.

Global Market Penetration

Partnering with regional manufacturers and navigating diverse regulatory environments can unlock emerging market opportunities.

R&D and Product Development

Innovations in drug delivery, combination therapies, and expanding indications (such as postpartum hemorrhage) could diversify revenue streams.

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Key Takeaways

• Mifeprex's market dynamics are intricately linked to regulatory policies, legal frameworks, and social debates surrounding abortion rights.
• Accessibility facilitated by regulatory amendments and telemedicine significantly influences its demand trajectory.
• Competitive pressures from generics and surgical alternatives necessitate strategic pricing and branding to preserve market share.
• Despite challenges, expanding global access and technological innovation present growth opportunities.
• Market stability hinges on navigating complex legal landscapes while advocating for evidence-based policies that support safe, accessible reproductive health solutions.

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FAQs

1. What are the current regulatory hurdles impacting Mifeprex sales?
   Variations in state laws, federal regulations, and international policies heavily influence access, with restrictions increasing in certain regions and relaxations occurring elsewhere due to FDA amendments and telemedicine legalization.

2. How does telemedicine influence Mifeprex's market trajectory?
   Telemedicine streamlines access, reduces logistical barriers, and has become a pivotal method for prescribing Mifeprex, especially under recent regulatory relaxations during the pandemic.

3. What is the potential impact of biosimilar entry on Mifeprex’s market share?
   Biosimilar and generic formulations will likely pressure pricing post-patent expiration, potentially reducing revenue margins but expanding market penetration through lower costs.

4. Are there emerging indications beyond reproductive health that could drive Mifeprex’s growth?
   Yes; off-label uses such as managing Cushing’s syndrome could create additional revenue streams, contingent on clinical validation and regulatory approval.

5. What strategic actions can pharmaceutical companies pursue to maximize Mifeprex’s market potential?
   Companies should focus on policy engagement, expanding telehealth services, global market entry, and innovation in formulations to maintain competitive advantage and foster sustainable growth.

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References

[1] U.S. Food and Drug Administration. Mifeprex (mifepristone) REMS. 2019.
[2] Guttmacher Institute. Abortion Incidence and Services in the United States. 2020.