DINOPROSTONE - Generic Drug Details

What are the generic sources for dinoprostone and what is the scope of freedom to operate?

Dinoprostone is the generic ingredient in three branded drugs marketed by Pfizer and Ferring Pharms Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dinoprostone. Two suppliers are listed for this compound.

Summary for DINOPROSTONE

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	80
Patent Applications:	7,560
What excipients (inactive ingredients) are in DINOPROSTONE?	DINOPROSTONE excipients list
DailyMed Link:	DINOPROSTONE at DailyMed

Recent Clinical Trials for DINOPROSTONE

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

Sponsor	Phase
Instituto de Salud Carlos III	Phase 3
Hospital Universitario 12 de Octubre	Phase 3
Spanish Clinical Research Network - SCReN	Phase 3

See all DINOPROSTONE clinical trials

Pharmacology for DINOPROSTONE

Drug Class

Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for DINOPROSTONE

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for DINOPROSTONE

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

US Patents and Regulatory Information for DINOPROSTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992		RX	Yes	Yes
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995		RX	Yes	Yes

Expired US Patents for DINOPROSTONE

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
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995

DINOPROSTONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dinoprostone

Introduction

Dinoprostone, a naturally occurring prostaglandin E2 (PGE2), is a crucial drug in obstetrics, used for labor induction, abortion, and the management of various gynecological conditions. Understanding the market dynamics and financial trajectory of dinoprostone is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Size and Growth

The global dinoprostone market is projected to witness significant growth over the forecast period from 2024 to 2031. The market size in 2023 was substantial, and it is expected to expand at a notable compound annual growth rate (CAGR)[1][4].

Segmentation

The dinoprostone market is segmented based on several key factors:

By Type

• Injection: This segment accounted for a noticeable share of the global dinoprostone market in 2023 and is expected to experience significant growth in the near future[1][4].
• Vaginal Suppository: Commonly known by brand names such as Cervidil and Prostin E2, this form is widely used for cervical ripening and labor induction[3][4].
• Gel: Prepidil gel is another form of dinoprostone, used for similar indications[3][4].
• Tablets and Other Forms: These segments, though smaller, contribute to the overall market diversity[4].

By Application

• Oxytocin: Dinoprostone is often used in conjunction with oxytocin for labor induction and management of postpartum hemorrhage[3][4].
• Induced Labor: This is one of the primary applications, where dinoprostone is used to prepare the cervix for labor and induce labor in women with an unfavorable cervix[2][3].
• Postpartum Hemorrhage: Dinoprostone can also be used to manage postpartum hemorrhage, a critical condition in obstetrics[3][4].

Regional Analysis

The market is segmented geographically into major regions:

• North America: A significant market due to advanced healthcare infrastructure and high demand for obstetric care[1][4].
• Europe: Another major region with a substantial market share, driven by healthcare standards and regulatory frameworks[1][4].
• Asia Pacific: This region is expected to grow rapidly due to increasing healthcare spending and a large population[1][4].
• Latin America, Middle East, and Africa: These regions also contribute to the global market, with growing demand for obstetric services[1][4].

Market Drivers

Several factors drive the growth of the dinoprostone market:

• Increasing Demand for Obstetric Care: The need for effective labor induction and management of gynecological conditions drives the demand for dinoprostone[3][4].
• Technological Innovations: Advances in drug delivery systems and formulations enhance the efficacy and safety of dinoprostone, making it more appealing to healthcare providers[4].
• Regulatory Support: Favorable regulatory environments in various regions support the approval and use of dinoprostone products[1][4].

Market Restraints

Despite the growth potential, there are several restraints to consider:

• Cost and Efficacy Comparisons: Studies have shown that other prostaglandin analogs, such as misoprostol, can be more cost-effective and have similar efficacy, which may impact dinoprostone's market share[2].
• Side Effects and Safety Concerns: Like any medication, dinoprostone has potential side effects and safety concerns that need to be managed, which can affect its adoption[3].

Competitive Landscape

The dinoprostone market is competitive, with several key players:

• Ferring: Known for its strong product portfolio and strategic initiatives in the global market[1][4].
• Pharmacia & Upjohn (Pfizer): A major player with a significant presence in the pharmaceutical industry[1][4].
• Actavis (TEVA): Another key player with a diverse range of pharmaceutical products[4].
• Controlled Therapeutics (Scotland) Limited: Specializes in controlled release technologies, including dinoprostone products[4].

Financial Performance

The financial performance of the dinoprostone market is robust, with significant revenue generated from various product forms and applications. Here are some key financial insights:

• Revenue Share: The injection segment, for instance, accounted for a noticeable share of the global dinoprostone market revenue in 2023[1].
• Cost-Effectiveness: While dinoprostone products are effective, they can be more expensive compared to other prostaglandin analogs. For example, a study found that misoprostol was more cost-effective than dinoprostone preparations for labor induction[2].

Technological Trends

Technological innovations play a crucial role in the dinoprostone market:

• Advanced Drug Delivery Systems: Improvements in vaginal suppositories and inserts enhance the efficacy and patient compliance of dinoprostone products[3][4].
• Research and Development: Ongoing R&D efforts focus on optimizing the performance of dinoprostone, enabling wider applications in obstetrics and gynecology[4].

Impact of COVID-19

The COVID-19 pandemic had various impacts on the dinoprostone market:

• Supply Chain Disruptions: Global supply chains were affected, leading to potential delays in the production and distribution of dinoprostone products[4].
• Increased Demand: The pandemic highlighted the importance of effective obstetric care, potentially increasing the demand for dinoprostone and other related medications[4].

Future Prospects

The future of the dinoprostone market looks promising, driven by several factors:

• Growing Demand for Obstetric Services: Increasing global population and the need for advanced obstetric care will continue to drive the demand for dinoprostone[3][4].
• Regulatory Support and Technological Advancements: Favorable regulatory environments and ongoing technological innovations will further optimize the performance and safety of dinoprostone products[1][4].

"Dinoprostone administered intravaginally stimulates the myometrium of the gravid uterus to contract in a manner that is similar to the contractions seen in the term uterus during labor, resulting in the evacuation of the products of conception from the uterus."[3]

Key Takeaways

• The global dinoprostone market is expected to grow significantly from 2024 to 2031.
• The market is segmented by type (injection, vaginal suppository, gel) and application (oxytocin, induced labor, postpartum hemorrhage).
• Key players include Ferring, Pharmacia & Upjohn (Pfizer), and Actavis (TEVA).
• Technological innovations and regulatory support are driving factors.
• The market faces restraints such as cost and efficacy comparisons with other prostaglandin analogs.

FAQs

What are the primary uses of dinoprostone?

Dinoprostone is used to induce labor, terminate pregnancy during the second trimester, manage nonmetastatic gestational trophoblastic disease, and treat postpartum hemorrhage[3].

Which companies are major players in the dinoprostone market?

Major players include Ferring, Pharmacia & Upjohn (Pfizer), Actavis (TEVA), and Controlled Therapeutics (Scotland) Limited[1][4].

How does dinoprostone compare to other prostaglandin analogs in terms of cost and efficacy?

Dinoprostone can be more expensive than other prostaglandin analogs like misoprostol, although it has similar efficacy in labor induction[2].

What are the key regions driving the growth of the dinoprostone market?

North America, Europe, and the Asia Pacific are significant regions driving the growth of the dinoprostone market[1][4].

How has the COVID-19 pandemic impacted the dinoprostone market?

The pandemic has caused supply chain disruptions but also highlighted the importance of effective obstetric care, potentially increasing demand for dinoprostone[4].

Sources

1. Global Dinoprostone Market Report 2024 Edition - Cognitivemarketresearch.com
2. Comparative efficacy and cost of the prostaglandin analogs - PubMed
3. Dinoprostone: Uses, Interactions, Mechanism of Action - DrugBank
4. Global Dinoprostone Market Research Report 2022 - Marketresearch.com