MIFEPRISTONE - Generic Drug Details

What are the generic sources for mifepristone and what is the scope of patent protection?

Mifepristone is the generic ingredient in three branded drugs marketed by Corcept Therap, Danco Labs Llc, Genbiopro, and Teva Pharms Usa Inc, and is included in four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mifepristone has thirty-nine patent family members in twelve countries.

There are six drug master file entries for mifepristone. Three suppliers are listed for this compound.

Summary for MIFEPRISTONE

International Patents:	39
US Patents:	18
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	196
Patent Applications:	7,191
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIFEPRISTONE
What excipients (inactive ingredients) are in MIFEPRISTONE?	MIFEPRISTONE excipients list
DailyMed Link:	MIFEPRISTONE at DailyMed

Recent Clinical Trials for MIFEPRISTONE

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
Astellas Pharma US, Inc.	Phase 2
Memorial Sloan Kettering Cancer Center	Phase 2

See all MIFEPRISTONE clinical trials

Pharmacology for MIFEPRISTONE

Drug Class	Progestin Antagonist
Mechanism of Action	Progestational Hormone Receptor Antagonists

Medical Subject Heading (MeSH) Categories for MIFEPRISTONE

Abortifacient Agents, Steroidal

Contraceptives, Oral, Synthetic

Contraceptives, Postcoital, Synthetic

Hormone Antagonists

Luteolytic Agents

Menstruation-Inducing Agents

Anatomical Therapeutic Chemical (ATC) Classes for MIFEPRISTONE

G03XB	Progesterone receptor modulators
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

Paragraph IV (Patent) Challenges for MIFEPRISTONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KORLYM	Tablets	mifepristone	300 mg	202107	1	2017-12-15

US Patents and Regulatory Information for MIFEPRISTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Teva Pharms Usa Inc	MIFEPRISTONE	mifepristone	TABLET;ORAL	211436-001	Aug 3, 2020	AB	RX	No	No
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes

Expired US Patents for MIFEPRISTONE

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 MIFEPRISTONE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017027851
Mexico	2018001803	METODO PARA DISGNOSTICAR DE MANERA DIFERENCIAL EL SINDROME DE CUSHING DEPENDIENTE DE LA CORTICOTROPINA. (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME.)
European Patent Office	3335043	PROCÉDÉ PERMETTANT D'ÉTABLIR UN DIAGNOSTIC DIFFÉRENTIEL DU SYNDROME DE CUSHING EN FONCTION DE L'HORMONE ADRÉNOCORTICOTROPE (ACTH) (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME)
South Korea	20180052120	ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법
Japan	7218294
South Korea	102197526

MIFEPRISTONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mifepristone

Market Size and Growth Projections

The abortion drugs market, which includes mifepristone, is experiencing significant growth. As of 2023, the abortion drugs market was valued at over USD 24.42 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2032, reaching an estimated value of USD 49.27 billion by 2032[1][3].

Role of Mifepristone in the Market

Mifepristone is a key player in this market, particularly in the context of medical abortions. The mifepristone segment is expected to record a CAGR of 8.6% from 2024 to 2032, driven by its pivotal role in abortion procedures, often used in conjunction with misoprostol. Mifepristone works by inhibiting progesterone and softening the cervix, facilitating embryo expulsion[1][3].

Distribution Channels and Accessibility

The distribution of mifepristone is expanding through various channels. Hospital pharmacies are expected to play a significant role, with this segment projected to reach over USD 29.6 billion by 2032. Additionally, regulatory changes, such as the FDA's decision to allow pharmacies to dispense abortion pills, are enhancing availability and convenience for individuals seeking medical abortion options[1][3].

Telemedicine and Online Pharmacies

Telemedicine and online pharmacies are also contributing to the increased accessibility of mifepristone. These platforms connect patients with healthcare providers, offering consultations and prescription services online, which is particularly beneficial for patients in remote areas. This integration is expected to continue enhancing the accessibility and convenience of abortion drugs across regions like North America[1].

Regulatory Landscape

The regulatory environment is crucial for the market dynamics of mifepristone. Recent regulatory reforms and approvals are facilitating broader access and use. For instance, the FDA's approval for pharmacies to dispense mifepristone has broadened access to medication abortion. However, legal battles, such as the one in the U.S. federal courts, pose challenges to the continuous availability of mifepristone. Despite these challenges, the drug remains widely available due to ongoing appeals and court rulings[1][5].

Cost-Effectiveness and Financial Impact

Studies have shown that mifepristone pretreatment, followed by misoprostol, is cost-effective compared to misoprostol alone for the medical management of early pregnancy loss. A randomized clinical trial found that mifepristone pretreatment had an incremental cost-effectiveness ratio (ICER) of $4225.43 per quality-adjusted life year (QALY) gained from the healthcare sector perspective, which is below commonly used cost-effectiveness thresholds. From a societal perspective, mifepristone pretreatment dominated misoprostol alone, indicating it is both clinically and economically beneficial[2].

Financial Barriers and Logistical Challenges

Despite the cost-effectiveness, financial barriers such as high costs and lack of insurance coverage continue to restrict the affordability of mifepristone. Logistical challenges, including limited availability and distribution networks, also hinder access to abortion drugs. These barriers are expected to impede access to safe and timely abortion care, limiting the product demand to some extent[1][3].

Regional Market Dynamics

The North America abortion drugs market is predicted to witness significant growth, with an estimated CAGR of 8.4% through 2032. This growth is attributed to the improved healthcare infrastructure and the increasing role of telemedicine and online pharmacies in providing these drugs[1].

Societal and Healthcare Trends

The demand for abortion drugs, including mifepristone, is driven by rising rates of abortions, particularly among teenagers and young adults. Inadequate sex education and inconsistent contraceptive use in certain regions contribute to this trend. Healthcare providers are responding by prescribing abortion medications more frequently, which in turn drives the market growth[1][3].

Legal and Political Implications

The legal battle over mifepristone continues, with significant implications for reproductive rights. Since the Dobbs decision, state legislatures have introduced various bills related to reproductive rights, challenging the availability of mifepristone. However, court rulings have so far maintained the drug's availability, albeit with some restrictions on its distribution and use[4][5].

Alternatives and Future Considerations

In the event of restrictions on mifepristone, medical providers are considering alternatives such as offering misoprostol alone for medical abortions. While misoprostol alone is used safely in many countries, it is considered slightly less effective and more likely to cause side effects compared to the combination of mifepristone and misoprostol[5].

Key Takeaways

• The abortion drugs market, led by mifepristone, is projected to grow significantly, reaching USD 49.27 billion by 2032.
• Mifepristone's role in medical abortions is pivotal, with a CAGR of 8.6% from 2024 to 2032.
• Regulatory changes and telemedicine are enhancing accessibility.
• Financial barriers and logistical challenges remain significant.
• The drug is cost-effective compared to misoprostol alone.
• Legal and political battles continue to shape the market landscape.

FAQs

1. What is the current market size of the abortion drugs market, and what is its projected growth? The abortion drugs market was valued at over USD 24.42 billion in 2023 and is estimated to grow at an 8.2% CAGR from 2024 to 2032, reaching over USD 49.27 billion by 2032[1][3].

2. How does mifepristone work in medical abortions? Mifepristone works by inhibiting progesterone and softening the cervix, facilitating embryo expulsion. It is often used in conjunction with misoprostol[1][3].

3. What are the key distribution channels for mifepristone? Hospital pharmacies and retail pharmacies, facilitated by regulatory changes and telemedicine, are key distribution channels for mifepristone[1][3].

4. Is mifepristone cost-effective compared to other treatments? Yes, mifepristone pretreatment followed by misoprostol is cost-effective compared to misoprostol alone, with an ICER of $4225.43 per QALY gained from the healthcare sector perspective[2].

5. What are the ongoing challenges to the availability of mifepristone? Ongoing legal battles, financial barriers, and logistical challenges such as limited availability and distribution networks continue to hinder the access to mifepristone[1][3][5].

Sources

1. Global Market Insights - Abortion Drugs Market Share – Trends Report, 2032
2. JAMA Network Open - Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss
3. Global Market Insights - Abortion Drugs Market Size - Global Market Insights
4. League of Women Voters - Where Things Stand in the Legal Battle Over Medication Abortion
5. PBS Frontline - The Fight Over the Abortion Pill Mifepristone and the Financial Impact of Abortion Access