CERVIDIL Drug Patent Profile

When do Cervidil patents expire, and when can generic versions of Cervidil launch?

Cervidil is a drug marketed by Ferring Pharms Inc and is included in one NDA.

The generic ingredient in CERVIDIL 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 CERVIDIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	6
Patent Applications:	4,901
Drug Prices:	Drug price information for CERVIDIL
What excipients (inactive ingredients) are in CERVIDIL?	CERVIDIL excipients list
DailyMed Link:	CERVIDIL at DailyMed

See drug prices for CERVIDIL

Recent Clinical Trials for CERVIDIL

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

Sponsor	Phase
Intermountain Health Care, Inc.	Phase 3
Saskatchewan Health Authority - Regina Area	N/A
Regina Qu'Appelle Health Region	N/A

See all CERVIDIL clinical trials

Pharmacology for CERVIDIL

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for CERVIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995		RX	Yes	Yes

Expired US Patents for CERVIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995

International Patents for CERVIDIL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2047094	CONTROLLED RELEASE COMPOSITIONS
Australia	537741
Japan	S56500253

CERVIDIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cervidil

Introduction to Cervidil

Cervidil, a prostaglandin E2 vaginal insert, is primarily used to induce labor in pregnant women. Understanding its market dynamics and financial trajectory involves analyzing various factors, including its usage, market size, competition, and regulatory approvals.

Market Size and Growth

While specific financial data for Cervidil alone is not readily available, it is part of the broader market for obstetric and gynecological treatments. Here are some key points to consider:

• Global Market Context: The global market for cervical cancer therapeutics, though not directly related to Cervidil, indicates a growing demand for advanced medical treatments in the gynecological sector. For instance, the global cervical cancer therapeutics market was valued at USD 5.80 billion in 2022 and is expected to reach USD 8.59 billion by 2031, growing at a CAGR of 4.47%[1].

Usage and Clinical Significance

• Clinical Efficacy: Cervidil has been shown to be effective in inducing labor. Clinical studies have demonstrated its efficacy, with treatment success rates ranging from 55% to 87% in different studies[3].
• Safety Profile: The drug is generally well-tolerated, with common adverse events including uterine hyperstimulation, fetal distress, and other minor symptoms. These are often manageable and reversible upon removal of the insert[3].

Regulatory Approvals and Compliance

• Health Canada and FDA Approval: Cervidil is authorized by health regulatory bodies such as Health Canada and the FDA. Compliance with these regulations is crucial for its continued market presence[4].

Competitive Landscape

• Market Competition: The obstetric and gynecological market is competitive, with various products available for labor induction and other related treatments. Cervidil competes with other prostaglandin E2 products and other labor induction methods.
• Innovations and R&D: Continuous innovation and research in the field of obstetrics and gynecology can impact the market share of Cervidil. Companies investing heavily in R&D, such as those in the cervical cancer therapeutics market, set a precedent for the importance of innovation in this sector[1].

Financial Performance of Related Companies

While direct financial data for Cervidil is not available, the financial performance of companies involved in similar therapeutic areas can provide insights:

• Pharmaceutical Industry Trends: Companies like AstraZeneca have seen significant growth in their oncology and rare disease segments, which can indicate a broader trend of increased investment in healthcare and pharmaceuticals. For example, AstraZeneca's oncology product sales increased by 19% in FY 2022[2].
• R&D Expenses: Companies like Cocrystal Pharma, though not directly related to Cervidil, spend substantial amounts on research and development. For instance, Cocrystal Pharma reported $3.242 million in R&D expenses for the third quarter of 2024, highlighting the importance of R&D in the pharmaceutical industry[5].

Regional Market Dynamics

• Global Reach: Cervidil is used in various regions, but its market dynamics can vary based on local healthcare infrastructure and regulatory environments.
• Healthcare Infrastructure: Regions with well-established healthcare infrastructure, such as the U.S., EU5, China, and Japan, are likely to have a higher demand for such products due to better access to healthcare services[1].

Challenges and Opportunities

• Challenges: One of the main challenges for Cervidil could be the emergence of new labor induction methods or drugs, which could potentially reduce its market share.
• Opportunities: Increasing awareness and advancements in gynecological treatments present opportunities for growth. The rising focus on women's health and the need for effective labor induction methods can drive demand for Cervidil.

Key Takeaways

• Market Growth: The broader gynecological and obstetric market is growing, driven by increased healthcare spending and advancements in medical treatments.
• Clinical Efficacy: Cervidil has a proven track record of efficacy and safety, which is crucial for its market presence.
• Regulatory Compliance: Compliance with health regulations is essential for the continued approval and use of Cervidil.
• Innovation and R&D: Continuous innovation and investment in R&D are vital for maintaining a competitive edge in the pharmaceutical market.

FAQs

1. What is Cervidil used for?

   • Cervidil is used to induce labor in pregnant women.

2. Is Cervidil safe?

   • Cervidil is generally well-tolerated, but it can cause uterine hyperstimulation and fetal distress, which are usually reversible upon removal of the insert.

3. Is Cervidil approved by regulatory bodies?

   • Yes, Cervidil is approved by health regulatory bodies such as Health Canada and the FDA.

4. How does Cervidil compare to other labor induction methods?

   • Cervidil competes with other prostaglandin E2 products and other labor induction methods, and its efficacy and safety profile make it a viable option.

5. What are the potential challenges for Cervidil in the market?

   • Emerging new labor induction methods or drugs could reduce its market share, but increasing awareness and advancements in gynecological treatments present opportunities for growth.

Cited Sources

1. Straits Research: Cervical Cancer Therapeutics Market Size, Demand, Report to 2031.
2. AstraZeneca: Full year and Q4 2022 results.
3. FDA: CERVIDIL - accessdata.fda.gov.
4. Health Canada: Details for: CERVIDIL - Drug and Health Products Portal.
5. Cocrystal Pharma: Cocrystal Pharma Reports Third Quarter 2024 Financial Results and ...