CYTOTEC Drug Patent Profile

Which patents cover Cytotec, and what generic alternatives are available?

Cytotec is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CYTOTEC is misoprostol. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cytotec

A generic version of CYTOTEC was approved as misoprostol by ANI PHARMS on July 10^th, 2002.

Summary for CYTOTEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	106
Patent Applications:	6,593
Drug Prices:	Drug price information for CYTOTEC
What excipients (inactive ingredients) are in CYTOTEC?	CYTOTEC excipients list
DailyMed Link:	CYTOTEC at DailyMed

See drug prices for CYTOTEC

Recent Clinical Trials for CYTOTEC

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

Sponsor	Phase
Stanford University	Phase 3
Cairo University	N/A
University of Texas at Austin	Phase 4

See all CYTOTEC clinical trials

Pharmacology for CYTOTEC

Drug Class

Prostaglandin E1 Analog

US Patents and Regulatory Information for CYTOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	AB	RX	Yes	No
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	AB	RX	Yes	Yes

Expired US Patents for CYTOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	4,459,310
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	4,301,146
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	4,301,146
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	4,060,691

International Patents for CYTOTEC

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

Country	Patent Number	Title	Estimated Expiration
Finland	750899
Australia	7947175
Finland	63747
Netherlands	183294

CYTOTEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Abortion Drugs: Focus on Mifepristone and Misoprostol (CYTOTEC)

Introduction

The abortion drugs market, particularly for medications like mifepristone and misoprostol (commonly known by the brand name Cytotec), is undergoing significant changes driven by societal, healthcare, and regulatory factors. This article delves into the market dynamics, financial trajectory, and the impact of these drugs on reproductive health and economic outcomes.

Market Size and Growth

The abortion drugs market was valued at over USD 24.42 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2032, reaching approximately USD 49.27 billion by 2032[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the abortion drugs market:

Rising Rate of Abortions

The increasing number of abortions is a primary driver, with approximately 642,700 medication abortions reported in the U.S. in 2023 alone[1][4].

Regulatory Approvals and Reforms

Regulatory changes, such as the FDA's decision to allow pharmacies to dispense abortion pills, are expanding access to these medications. This includes broader access through telemedicine and online pharmacies, especially in regions like North America[1][4].

Technological Advancements

Pharmaceutical companies are focusing on developing improved formulations to enhance patient outcomes. This includes refining the application of mifepristone and misoprostol to minimize risks and improve efficacy[1].

Distribution Channels

Hospital Pharmacies

The hospital pharmacies segment is expected to play a pivotal role, reaching over USD 29.6 billion by 2032. These pharmacies ensure strict adherence to regulations and provide comprehensive patient care, including counseling and support[1].

Retail Pharmacies

The recent FDA approval allowing retail pharmacies to dispense abortion pills has significantly expanded access. This change enables more convenient and widespread availability of mifepristone and misoprostol[4].

Regional Market Dynamics

North America

The North American market is anticipated to grow at a CAGR of 8.4% through 2032, driven by an improved healthcare infrastructure and the integration of telemedicine and online pharmacies. These platforms enhance accessibility, especially in remote areas[1].

Financial Impact of Abortion Access

Economic Consequences of Denied Abortions

Research has shown that denying access to abortions can have severe and long-lasting negative economic effects on individuals. A study published in the American Economic Journal: Economic Policy found that people denied abortions experienced a 78% increase in debt 30 days or more past due and an 81% increase in negative public records, such as evictions and bankruptcies, compared to those who received abortions[2].

Financial Hardship

The financial hardship associated with denied abortions is significant. For instance, a couple featured in a documentary explained that their decision to have an abortion was largely due to their financial situation, highlighting the economic strain of unwanted pregnancies[2].

Misoprostol (Cytotec) Specifics

Clinical Use

Misoprostol, often used in conjunction with mifepristone, is crucial in abortion procedures. It helps in softening the cervix and facilitating embryo expulsion. Misoprostol is also used prophylactically to prevent gastric ulcers among nonsteroidal anti-inflammatory drug users[1][3].

Economic Benefits

The prophylactic use of misoprostol can be cost-reducing, especially in the initial three months of treatment, when compliance rates are high and the silent ulcer rate is significant. However, the economic benefits are highly sensitive to changes in compliance rates and medication pricing[3].

Self-Managed Abortions

Studies have explored the experiences of individuals using misoprostol-only for self-managed abortions. These studies highlight the need for clear guidelines and support to ensure safe and effective use[5].

Challenges and Pitfalls

Logistical Barriers

Despite the growing demand, logistical challenges such as limited availability and distribution networks hinder access to abortion drugs. Financial barriers, including high costs and lack of insurance coverage, further restrict affordability[1][4].

Regulatory Uncertainties

Legal battles over the approval and distribution of abortion medications, such as the recent ruling on mifepristone, create regulatory uncertainties that can impact market stability and patient access[2].

Industry Players and Innovations

Major pharmaceutical companies are actively involved in the production and distribution of abortion drugs. These companies are innovating and expanding their offerings to meet evolving healthcare needs and regulatory changes. Partnership strategies and R&D initiatives are key to their growth and market presence[1].

Key Takeaways

• The abortion drugs market is projected to grow significantly, driven by increasing demand and regulatory changes.
• Mifepristone and misoprostol are central to this growth, with mifepristone expected to record an 8.6% CAGR from 2024-2032.
• Regulatory approvals and reforms are crucial in expanding access to these medications.
• Financial barriers and logistical challenges remain significant hurdles.
• The economic impact of denied abortions highlights the importance of accessible reproductive healthcare.

FAQs

What is the projected market size of the abortion drugs market by 2032?

The abortion drugs market is estimated to reach over USD 49.27 billion by 2032, growing at a CAGR of 8.2% from 2024-2032[1][4].

How do regulatory changes impact the abortion drugs market?

Regulatory changes, such as the FDA's approval for pharmacies to dispense abortion pills, significantly expand access and convenience for individuals seeking medical abortion options[1][4].

What are the economic consequences of denying access to abortions?

Denying access to abortions can lead to significant and long-lasting negative economic effects, including increased debt and negative public records such as evictions and bankruptcies[2].

What is the role of misoprostol in abortion procedures?

Misoprostol is used in conjunction with mifepristone to soften the cervix and facilitate embryo expulsion. It is also used prophylactically to prevent gastric ulcers[1][3].

How are pharmaceutical companies adapting to the evolving market?

Pharmaceutical companies are innovating, expanding their offerings, and engaging in partnership strategies and R&D initiatives to meet growing demand and adapt to regulatory changes[1].

Sources

1. Global Market Insights: Abortion Drugs Market Share – Trends Report, 2032.
2. PBS: The Fight Over the Abortion Pill Mifepristone and the Financial Impact of Abortion Access.
3. PubMed: Economic effects of prophylactic use of misoprostol to prevent gastric ulcers.
4. Global Market Insights: Abortion Drugs Market Size - Global Market Insights.
5. Contraception Journal: Experiences with misoprostol-only used for self-managed abortion among people living in the United States.