PREPIDIL Drug Patent Profile

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

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

The generic ingredient in PREPIDIL 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 PREPIDIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	4
Patent Applications:	4,901
Drug Prices:	Drug price information for PREPIDIL
What excipients (inactive ingredients) are in PREPIDIL?	PREPIDIL excipients list
DailyMed Link:	PREPIDIL at DailyMed

See drug prices for PREPIDIL

Recent Clinical Trials for PREPIDIL

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

Sponsor	Phase
Clinical Hospital Merkur	Phase 4
University of South Carolina	N/A
American University of Beirut Medical Center	Phase 3

See all PREPIDIL clinical trials

Pharmacology for PREPIDIL

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for PREPIDIL

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

Expired US Patents for PREPIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992

International Patents for PREPIDIL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	7603064
Germany	2611183
European Patent Office	0089768	COMPOSITIONS CONTAINING PROSTAGLANDINS
Netherlands	190539
Hong Kong	91993	COMPOSITIONS CONTAINING PROSTAGLANDINS

PREPIDIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: PREPIDIL

Introduction

PREPIDIL, a dinoprostone gel, is a prostaglandin E2 used for cervical ripening and labor induction. Understanding its market dynamics and financial trajectory involves analyzing various factors, including pricing, competition, regulatory influences, and clinical efficacy.

Clinical Efficacy and Cost Comparison

Clinical Trials and Efficacy

Studies have compared the efficacy and cost of PREPIDIL with other prostaglandin analogues. A prospective randomized clinical trial compared misoprostol (Cytotec), dinoprostone gel (Prepidil), and dinoprostone pessary (Cervidil) for labor preinduction. The results showed that while PREPIDIL was effective, it was less cost-effective compared to misoprostol. Specifically, the average relative cost per patient for PREPIDIL was $184.17, significantly higher than misoprostol at $0.42[2].

Time to Delivery and Overall Costs

The same study highlighted that PREPIDIL resulted in a longer time to delivery (33.9 hours) compared to misoprostol (24.0 hours) and Cervidil (32.2 hours). This longer duration contributed to higher overall mean costs per patient for PREPIDIL, at $1124.84, compared to $723.66 for misoprostol and $1058.90 for Cervidil[2].

Pricing Trends

Historical Pricing Data

Data from the Minnesota Department of Health shows that the price of PREPIDIL has fluctuated over the years. For instance, between 2012 and 2023, the wholesale acquisition cost (WAC) of PREPIDIL 0.5mg Gel increased from $566.54 to $687.519, indicating a gradual price increase[1].

Factors Influencing Price Changes

Price changes for PREPIDIL, like other medicines, can be influenced by several factors, including the discovery of new uses and patient populations, new or expiring patents, improvements in manufacturing and supply chains, new formulations, market-based factors, and changes in local laws and mandates[1].

Market Competition

Generic Competition

The entry of generic competitors can significantly impact the pricing and market share of brand-name drugs like PREPIDIL. Research indicates that generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are eight or more competitors. However, the initial generic monopolist can charge prices 35% to 50% above long-run marginal costs[3].

Impact on PREPIDIL

While PREPIDIL is a brand-name drug, the presence of generic alternatives like misoprostol can exert downward pressure on its pricing. The cost-effectiveness of these generics can lead to a shift in market share, potentially reducing the revenue and profitability of PREPIDIL.

Regulatory Influences

FDA Policies

Regulatory policies by the FDA can also affect the market dynamics of PREPIDIL. For example, the FDA's increased scrutiny of generic drug applications and the simultaneous approval of multiple generic entrants can lead to earlier competition and lower prices. However, this can also reduce expected rents, potentially discouraging some firms from entering the market[3].

Consumer and Market Impact

Affordability and Access

High prices of prescription drugs, including PREPIDIL, can affect consumer affordability and access. Reports from Oregon's Drug Price Transparency Program highlight that many people struggle to afford necessary medications, and significant price increases can exacerbate this issue[4].

Market Trends and COVID-19

The COVID-19 pandemic has introduced additional market dynamics, including changes in prescription drug spending and trends. While PREPIDIL's market may not have been directly impacted by COVID-19, broader trends in the prescription drug market, such as increased scrutiny on pricing and transparency, can influence its financial trajectory[4].

Financial Trajectory

Revenue and Profitability

The financial trajectory of PREPIDIL is influenced by its pricing, market share, and competition. Given the higher costs and lower cost-effectiveness compared to generics, PREPIDIL's revenue and profitability may face challenges. As generic competition increases and regulatory pressures mount, the brand may need to adjust its pricing strategy to remain competitive.

Future Outlook

In the future, PREPIDIL's financial performance will likely be shaped by the ongoing dynamics in the generic drug market, regulatory changes, and consumer demand. The drug's ability to maintain market share will depend on its clinical value, pricing strategy, and the company's investment in research and development to enhance its product offerings.

Key Takeaways

• Clinical Efficacy: PREPIDIL is effective but less cost-effective compared to generic alternatives like misoprostol.
• Pricing Trends: The price of PREPIDIL has increased over the years, influenced by various market and regulatory factors.
• Market Competition: Generic competition significantly impacts the pricing and market share of PREPIDIL.
• Regulatory Influences: FDA policies on generic drug approvals can affect the competitive landscape and pricing of PREPIDIL.
• Consumer Impact: High prices can affect consumer affordability and access to PREPIDIL.

FAQs

What is PREPIDIL used for?

PREPIDIL is used for cervical ripening and labor induction.

How does PREPIDIL compare to other prostaglandin analogues in terms of cost?

PREPIDIL is significantly more expensive than misoprostol (Cytotec) and has a higher overall cost per patient for labor induction[2].

What factors influence the price of PREPIDIL?

The price of PREPIDIL can be influenced by the discovery of new uses, new or expiring patents, improvements in manufacturing, market-based factors, and changes in local laws and mandates[1].

How does generic competition affect PREPIDIL's market share?

Generic competition can reduce PREPIDIL's market share and pricing power, as generic drugs often offer more cost-effective alternatives[3].

What is the impact of FDA policies on PREPIDIL's financial trajectory?

FDA policies, such as increased scrutiny of generic drug applications and simultaneous approvals, can lead to earlier competition and lower prices, affecting PREPIDIL's revenue and profitability[3].

Sources

1. Minnesota Department of Health - Prescription Drug Price Growth Report Data
2. PubMed - Comparative cost analysis of prostaglandin analogues dinoprostone
3. Federal Trade Commission - Generic Drug Industry Dynamics
4. Oregon Department of Consumer and Business Services - Prescription Drug Price Transparency Program results and market dynamics