Misoprostol - Generic Drug Details

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

Misoprostol is the generic ingredient in two branded drugs marketed by Pfizer, Acq Pharma, Ani Pharms, Micro Labs, and Novel Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for misoprostol. Seventeen suppliers are listed for this compound.

Summary for misoprostol

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	455
Patent Applications:	7,683
Drug Prices:	Drug price trends for misoprostol
What excipients (inactive ingredients) are in misoprostol?	misoprostol excipients list
DailyMed Link:	misoprostol at DailyMed

See drug prices for misoprostol

See drug sales revenues for misoprostol

Recent Clinical Trials for misoprostol

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

Sponsor	Phase
University of Maryland, Baltimore	Early Phase 1
Kazakhstan's Medical University "KSPH"	Phase 4
Asfendiyarov Kazakh National Medical University	Phase 4

See all misoprostol clinical trials

Pharmacology for misoprostol

Drug Class

Prostaglandin E1 Analog

Medical Subject Heading (MeSH) Categories for misoprostol

Abortifacient Agents, Nonsteroidal

Anti-Ulcer Agents

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for misoprostol

A02BB	Prostaglandins
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

G02AD	Prostaglandins
G02A	UTEROTONICS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for misoprostol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acq Pharma	MISOPROSTOL	misoprostol	TABLET;ORAL	210201-002	Jul 2, 2019	AB	RX	No	No
Ani Pharms	MISOPROSTOL	misoprostol	TABLET;ORAL	076095-001	Jul 10, 2002	AB	RX	No	No
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	AB	RX	Yes	No
Micro Labs	MISOPROSTOL	misoprostol	TABLET;ORAL	216872-001	Oct 17, 2022	AB	RX	No	No
Novel Labs Inc	MISOPROSTOL	misoprostol	TABLET;ORAL	091667-001	Jul 25, 2012		DISCN	No	No
Acq Pharma	MISOPROSTOL	misoprostol	TABLET;ORAL	210201-001	Jul 2, 2019	AB	RX	No	No

Expired US Patents for misoprostol

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
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	3,965,143

Misoprostol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Misoprostol

Introduction

Misoprostol, a synthetic prostaglandin E1 analogue, has been a crucial medication in various medical fields, including gastroenterology and obstetrics. Its market dynamics are influenced by several factors, including clinical applications, regulatory environments, and economic considerations. Here, we delve into the market trends, financial projections, and key drivers shaping the misoprostol market.

Market Size and Growth

The global misoprostol market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 1.2 billion to USD 1.4 billion[1][5]. By 2032, the market is projected to reach USD 2.4 billion to USD 2.6 billion, with a compound annual growth rate (CAGR) of around 8-9%[1][5].

Market Drivers

Several factors are driving the growth of the misoprostol market:

Clinical Applications

Misoprostol is widely used to prevent gastric ulcers in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs), particularly those with osteoarthritis. Its prophylactic use has been shown to reduce the rate of gastric ulcers significantly, making it a preferred strategy in certain clinical scenarios[2].

Obstetric Use

In obstetrics, misoprostol is used to prevent postpartum hemorrhage (PPH), especially in settings where access to healthcare facilities is limited. Its ease of administration, stability at room temperature, and effectiveness make it a vital tool in resource-limited countries[4].

Regulatory Support

Regulatory approvals and guidelines supporting the use of misoprostol in various indications also contribute to market growth. For instance, its approval for use in preventing PPH has expanded its market reach in regions with high home birth rates.

Market Opportunities

Expanding into New Markets

The misoprostol market has opportunities for expansion into new geographic regions, particularly in developing countries where access to healthcare is limited. The prenatal distribution of misoprostol to prevent PPH is a strategy being explored in several countries, which could significantly increase market size[4].

Diversification of Applications

Beyond its current uses, research into new applications of misoprostol could open up additional market opportunities. For example, its potential use in other gastrointestinal conditions or in different stages of pregnancy could expand its market share.

Market Challenges

Economic Considerations

While misoprostol is cost-effective in many scenarios, its economic impact can vary. For instance, the cost-effectiveness of prenatal misoprostol distribution to prevent PPH shows mixed results, with higher costs from a governmental perspective but potential savings from a societal perspective[4].

Compliance and Adherence

The effectiveness of misoprostol is highly sensitive to compliance rates. Lower compliance can reduce its cost-effectiveness and overall impact, making patient education and adherence programs crucial[2].

Regulatory Hurdles

Regulatory changes and stringent approval processes can pose challenges to market growth. Ensuring compliance with local regulations and obtaining necessary approvals can be time-consuming and costly.

Financial Trajectory

Revenue Projections

The projected revenue growth from USD 1.2 billion to USD 2.4 billion by 2032 indicates a robust financial trajectory for the misoprostol market. This growth is driven by increasing demand, expanding applications, and growing acceptance in new markets[1].

Cost-Effectiveness

Studies have shown that misoprostol can be cost-reducing in certain scenarios. For example, prophylactic use of misoprostol to prevent gastric ulcers can reduce direct medical costs, especially in the initial three months of treatment[2].

Economic Impact

In obstetric care, the cost-effectiveness of misoprostol distribution varies. While it may increase costs from a governmental perspective, it can offer significant savings from a societal perspective by reducing the incidence of PPH and associated healthcare costs[4].

Regional Dynamics

Global Market

The global misoprostol market is influenced by regional health policies, economic conditions, and healthcare infrastructure. Regions with high home birth rates and limited access to healthcare facilities are particularly significant for the obstetric use of misoprostol[4].

Macro-Economic Factors

Global economic trends, including inflation and healthcare spending, also impact the misoprostol market. Economic downturns can affect healthcare budgets, while economic growth can lead to increased spending on healthcare services and medications[3].

Competitive Landscape

The misoprostol market is characterized by a competitive landscape with several key players. Companies are focusing on tailoring their reports and strategies to meet specific regional and segment requirements, which helps in maintaining market share and expanding into new areas[1].

Key Takeaways

• Market Growth: The misoprostol market is expected to grow significantly, reaching USD 2.4 billion to USD 2.6 billion by 2032.
• Clinical Applications: Misoprostol's use in preventing gastric ulcers and PPH drives its market.
• Economic Considerations: Cost-effectiveness varies by scenario, but overall, misoprostol can offer significant economic benefits.
• Regional Dynamics: The market is influenced by regional health policies, economic conditions, and healthcare infrastructure.
• Competitive Landscape: The market is competitive, with companies tailoring strategies to meet specific regional needs.

FAQs

Q: What is the current market size of the misoprostol market? A: The current market size of the misoprostol market is approximately USD 1.2 billion to USD 1.4 billion as of 2023[1][5].

Q: What is the projected growth rate of the misoprostol market? A: The misoprostol market is projected to grow at a CAGR of around 8-9% from 2024 to 2032[1][5].

Q: What are the primary clinical applications of misoprostol? A: Misoprostol is primarily used to prevent gastric ulcers in NSAID users and to prevent postpartum hemorrhage (PPH) in obstetric care[2][4].

Q: How does misoprostol impact healthcare costs? A: Misoprostol can reduce healthcare costs in certain scenarios, such as preventing gastric ulcers, but may increase costs in others, like prenatal distribution for PPH prevention[2][4].

Q: What are the key challenges facing the misoprostol market? A: Key challenges include compliance and adherence issues, regulatory hurdles, and varying economic impacts depending on the scenario[2][4].

Sources

1. Dataintelo: Global Misoprostol Market Research Report 2032.
2. PubMed: Economic effects of prophylactic use of misoprostol to prevent gastric ulcers.
3. Southeast News Channel Nebraska: Misoprostol Market Size Research Report 2032.
4. PLOS ONE: Potential Cost-Effectiveness of Prenatal Distribution of Misoprostol.
5. Verified Market Research: Misoprostol Market Size, Share, Scope, Trends And Forecast.