PROSTIN E2 Drug Patent Profile

Which patents cover Prostin E2, and when can generic versions of Prostin E2 launch?

Prostin E2 is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in PROSTIN E2 is dinoprostone. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dinoprostone profile page.

Summary for PROSTIN E2

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	12
Patent Applications:	4,901
Drug Prices:	Drug price information for PROSTIN E2
DailyMed Link:	PROSTIN E2 at DailyMed

See drug prices for PROSTIN E2

Recent Clinical Trials for PROSTIN E2

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

Sponsor	Phase
University Medical Centre Maribor	Phase 4
Aswan University Hospital	N/A
Ministry of Health, Singapore	N/A

See all PROSTIN E2 clinical trials

US Patents and Regulatory Information for PROSTIN E2

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for PROSTIN E2

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982	3,598,858
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982	3,899,587

International Patents for PROSTIN E2

See the table below for patents covering PROSTIN E2 around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1040545
United Kingdom	1040544
Germany	1643739	Epi-PGF,Bisdehydro-epi-PGF,Tetradehydro-epi-PGF,deren Methylester und Methylestertriacetate und Verfahren zu ihrer Herstellung

PROSTIN E2 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PROSTIN E2

Introduction

PROSTIN E2, a formulation of dinoprostone, is a prostaglandin E2 used primarily for the induction of labor and cervical ripening. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Size and Growth

The global prostaglandin E2 receptor EP4 subtype market, which includes drugs like PROSTIN E2, has been experiencing significant growth. As of 2021, the market size was valued at USD 137.75 million and is projected to reach USD 352.34 million by 2027, indicating a substantial increase in demand and usage[1].

Projected Market Value

By 2032, the global prostaglandin E2 receptor EP4 subtype market is expected to reach USD 0.77 billion, reflecting a robust growth trajectory driven by various factors[1].

Compound Annual Growth Rate (CAGR)

The market is anticipated to exhibit a CAGR of 16.94% by 2032, highlighting the rapid expansion and potential for continued growth in the coming years[1].

Driving Factors

Several factors are driving the growth of the PROSTIN E2 market:

Increased Prevalence of Chronic Inflammatory Diseases

The rising incidence of chronic inflammatory diseases has amplified the need for effective treatments, and PROSTIN E2, with its role in modulating inflammatory responses, is benefiting from this trend[1].

Growing Recognition of EP4 in Cancer

The increasing recognition of the EP4 receptor subtype in cancer treatment is opening new avenues for PROSTIN E2, potentially improving patient outcomes and driving market growth[1].

Obstetric Applications

PROSTIN E2's primary use in obstetrics for labor induction and cervical ripening continues to be a significant driver, given the consistent demand for safe and effective methods in this field[3][5].

Key Players

The market for PROSTIN E2 is dominated by several key players:

AskAt (Japan)

Eisai Inc (U.S.)

Kaken Pharmaceutical (Japan)

Ono Pharmaceutical (Japan)

Rottapharm Biotech (Italy)

Eli Lilly (U.S.)

These companies are instrumental in driving innovation, production, and distribution of PROSTIN E2 and related prostaglandin E2 products[1].

Cost-Effectiveness

Studies have shown that PROSTIN E2, particularly in its gel form, is more cost-effective than other formulations for labor induction. For instance, a study conducted in the UK found that prostaglandin E2 gel is likely more cost-effective than prostaglandin E2 tablets for the induction of labor at term[2].

Clinical Use and Administration

PROSTIN E2 is administered in various forms, including oral and vaginal tablets. The drug is used to stimulate uterine contractions and facilitate cervical ripening, making it a critical tool in obstetric care. The dosing and administration are carefully managed to avoid adverse effects such as uterine hyperstimulation and fetal distress[3][5].

Pharmacological Properties

PROSTIN E2 works by stimulating the myometrium of the gravid uterus to contract, similar to natural labor contractions. It also has a local effect on the cervix, promoting softening, effacement, and dilation. Additionally, it can affect smooth muscle in the gastrointestinal tract and vascular system, leading to potential side effects like vomiting, diarrhea, and lowered blood pressure[5].

Safety and Side Effects

While PROSTIN E2 is generally safe when used as directed, it can have significant side effects, including uterine hypercontractility, fetal distress, and rare but serious complications such as post-partum disseminated intravascular coagulation. Careful monitoring and adherence to recommended dosages are essential to mitigate these risks[3][5].

Market Segmentation

The broader prostaglandin market, which includes PROSTIN E2, is segmented by application, delivery route, type, and derivative. Key applications include ophthalmology, gastrointestinal diseases, and obstetrics and gynecology. The market is also segmented by delivery routes such as intravitreal injection, intracameral injection, oral, and topical administration[4].

Regional Analysis

The market for PROSTIN E2 and related prostaglandins is analyzed across various regions, including North America, Europe, South America, Asia Pacific, and the Middle East and Africa. Each region presents unique market dynamics influenced by local healthcare needs, regulatory environments, and economic conditions[4].

Financial Implications

The growing demand for PROSTIN E2 and its increasing market value have significant financial implications for pharmaceutical companies and investors. The projected growth indicates potential for substantial revenue increases, making this market an attractive sector for investment and expansion.

Key Takeaways

• The global prostaglandin E2 receptor EP4 subtype market is expected to reach USD 0.77 billion by 2032.
• The market is driven by the increasing prevalence of chronic inflammatory diseases and growing recognition of EP4 in cancer.
• Key players such as AskAt, Eisai Inc, and Eli Lilly dominate the market.
• PROSTIN E2 is more cost-effective in gel form for labor induction.
• The drug has specific pharmacological properties and potential side effects that require careful management.

FAQs

What is the expected market value of the prostaglandin E2 receptor EP4 subtype market by 2032?

The global prostaglandin E2 receptor EP4 subtype market is expected to reach USD 0.77 billion by 2032[1].

What is the CAGR of the prostaglandin E2 receptor EP4 subtype market?

The market is expected to exhibit a CAGR of 16.94% by 2032[1].

What are the primary applications of PROSTIN E2?

PROSTIN E2 is primarily used for the induction of labor and cervical ripening in obstetrics[3][5].

Which companies are the key players in the PROSTIN E2 market?

Key players include AskAt, Eisai Inc, Kaken Pharmaceutical, Ono Pharmaceutical, Rottapharm Biotech, and Eli Lilly[1].

Is PROSTIN E2 more cost-effective in gel or tablet form for labor induction?

Studies suggest that PROSTIN E2 gel is more cost-effective than PROSTIN E2 tablets for the induction of labor at term[2].

Sources

1. Business Research Insights: Prostaglandin E2 Receptor EP4 Subtype Market Forecast To 2031
2. PubMed: Cost-effectiveness analysis of prostaglandin E2 gel for the induction of labour at term
3. Pfizer Labeling: Prostin E2® Dinoprostone Oral Tablets/Vaginal Tablets
4. Market Research Future: Prostaglandin Market Size, Growth, Trends, Report 2032
5. Pfizer Labeling: PROSTIN E2® Dinoprostone Vaginal Tablets/Oral Tablets