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	4,626,531
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	4,386,085
Danco Labs Llc	MIFEPREX	mifepristone	TABLET;ORAL	020687-001	Sep 28, 2000	4,447,424

International Patents for MIFEPREX

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

Country	Patent Number	Title	Estimated Expiration
Finland	820042
Germany	3471588
Japan	H0234958

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: February 26, 2026

What is the current market landscape for MIFEPREX?

MIFEPREX, the brand name for mifepristone, received approval from the FDA in 2000 for medical abortion up to 10 weeks' gestation. Globally, its primary use remains in early pregnancy termination. The drug also has applications in treating Cushing's syndrome and certain psychiatric conditions involving psychotic features.

The global abortion drug market has experienced consistent growth, driven by increasing acceptance of medical abortion, legal reforms, and expanding healthcare access. The market was valued at approximately USD 1.6 billion in 2022 and is projected to reach USD 2.7 billion by 2030, with a compound annual growth rate (CAGR) of 6.4% [1].

How do regulatory and legal factors influence MIFEPREX’s market?

Legal environment varies significantly. In the US, the FDA approved MIFEPREX under REMS (Risk Evaluation and Mitigation Strategy) in 2016, limiting distribution to certified providers. Legislative debates on abortion access have impacted market stability, with some states enacting restrictions.

Internationally, the drug's approval status varies:

• Europe: Approved in multiple countries, with some restricting its use.
• Latin America/Africa/Asia: Approval pending or restricted, often influenced by local laws and cultural factors.

Legal restrictions directly influence sales volume, geographic expansion, and market penetration.

What competitive forces shape MIFEPREX sales?

Key players include Pfizer (original manufacturer), with other generic producers entering in markets where patent restrictions lapse. Pfizer, as of 2022, maintains patent exclusivity in certain regions until 2024, after which generics are expected to enter.

Alternative methods of abortion, such as surgical procedures or other drugs like misoprostol alone, influence market share. Misoprostol is often used in combination or as an alternative, especially in regions with limited access to mifepristone.

Therapeutic repurposing for conditions like Cushing’s syndrome opens additional markets, although these constitute a smaller segment relative to reproductive health applications.

What are the key financial indicators for MIFEPREX?

Pfizer reported approximately USD 100 million in sales of MIFEPREX worldwide in 2021. The US accounted for roughly 60% of this revenue, constrained by REMS limitations and legislative restrictions.

Sales are expected to grow steadily with increased access in regions with loosened restrictions, especially as generic formulations enter the market post-patent expiry. The revenue from non-reproductive indications, such as Cushing's syndrome, remains marginal but may expand with targeted marketing and new indications.

What future trends could impact MIFEPREX's market?

• Legal and policy developments: Changes in abortion laws, especially in the US post-2022 Dobbs decision, affect distribution channels.
• Patent expirations: Pfizer’s key patents expire in 2024, opening markets for generics, which usually drive prices down but increase volume.
• Technological advances: Telemedicine facilitates distribution of medical abortion drugs in restrictive regions, potentially expanding access.
• Competitive products: Development of new drugs or combination therapies may substitute MIFEPREX in certain markets, impacting sales.

What are the risks and opportunities ahead?

Risks:

• Regulatory restrictions can reduce market access.
• Political opposition and legislative bans impede growth.
• Legal challenges related to abortion laws may limit clinic availability.

Opportunities:

• Expand approvals in emerging markets with high unmet demand.
• Develop new formulations or combination therapies.
• Leverage telemedicine for distribution, especially outside the US.

Summary table: Estimated MIFEPREX Market Data

Parameter	2022 Data	Projection	Notes
Market Size	USD 1.6 billion	USD 2.7 billion	By 2030, CAGR 6.4%
Pfizer's 2021 Revenue	USD 100 million	-	US primary market, subject to restrictions
Patent Expiry	2024	-	Generics expected post-expiry
US Market Share	60%	-	Constrained by REMS, legislation

Key Takeaways

• MIFEPREX's market is expanding globally, primarily driven by reproductive health needs.
• Legal, regulatory, and political factors heavily influence sales and access.
• Patent expiration in 2024 will likely lead to increased generic competition, reducing prices but potentially increasing total volume.
• Technological shifts such as telemedicine may expand distribution channels in restrictive regions.
• Non-reproductive therapeutic uses remain niche but could grow with increased awareness.

FAQs

1. When does the Pfizer patent for MIFEPREX expire?
The patent is valid until 2024 in key markets, after which generics can enter.

2. What are the primary regulatory hurdles for MIFEPREX?
In the US, REMS restrictions limit distribution to certified providers. Internationally, approval varies, often influenced by local laws.

3. How does legislation affect MIFEPREX sales in the US?
Legal restrictions at state levels, including bans and gestational limits, significantly reduce accessible markets.

4. Are there alternatives to MIFEPREX?
Yes. Misoprostol alone is used in some regions; new drugs are in development but have not yet gained widespread approval.

5. What is the outlook for MIFEPREX in emerging markets?
As regulatory barriers ease and demand grows, markets in Asia and Africa represent growth opportunities, contingent on local approval processes.

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References

[1] Grand View Research. (2023). Global abortion drugs market size, share & trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/abortion-drugs-market