FEMSTAT Drug Patent Profile

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

Femstat is a drug marketed by Roche Palo and Bayer and is included in three NDAs.

The generic ingredient in FEMSTAT is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

Summary for FEMSTAT

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	105
Patent Applications:	1,055
DailyMed Link:	FEMSTAT at DailyMed

US Patents and Regulatory Information for FEMSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche Palo	FEMSTAT	butoconazole nitrate	CREAM;VAGINAL	019215-001	Nov 25, 1985		DISCN	No	No
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985		DISCN	No	No
Bayer	FEMSTAT 3	butoconazole nitrate	CREAM;VAGINAL	020421-001	Dec 21, 1995		DISCN	Yes	No

Expired US Patents for FEMSTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	FEMSTAT	butoconazole nitrate	CREAM;VAGINAL	019215-001	Nov 25, 1985
Roche Palo	FEMSTAT	butoconazole nitrate	SUPPOSITORY;VAGINAL	019359-001	Nov 25, 1985

International Patents for FEMSTAT

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

Country	Patent Number	Title	Estimated Expiration
Spain	450204
Denmark	81276
Canada	1077493	DERIVES DE N-ALKYL-IMIDAZOLES SUBSTITUES (DERIVATIVES OF SUBSTITUTED N-ALKYL IMIDAZOLES)

FEMSTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oncology Drugs: A Case Study

Introduction

The oncology drugs market is one of the most dynamic and rapidly growing segments within the pharmaceutical industry. This article will delve into the market dynamics, financial trajectory, and key factors influencing the growth of oncology drugs, using the broader context to infer insights relevant to a drug like FEMSTAT, although specific data on FEMSTAT may not be available.

Global Oncology Drugs Market Overview

The global oncology drugs market is valued at $231.56 billion in 2024 and is projected to reach $532.91 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 12.6% during the forecast period[1].

Market Drivers

Increasing Prevalence of Cancer

The rising global incidence of cancer is a primary driver of the oncology drugs market. According to the World Health Organization (WHO), cancer is the second leading cause of death worldwide, which has led to an increased demand for effective cancer treatments[1].

Adoption of Targeted Therapies and Immunotherapies

The adoption of targeted therapies and immunotherapies is another significant factor driving market growth. These therapies offer higher efficacy and reduced side effects compared to traditional treatments, making them highly sought after by patients and healthcare providers[1].

Advancements in Drug Delivery Systems

Advancements in targeted drug delivery systems have led to the development of innovative drugs with improved efficacy and safety profiles. This technological progress is a key driver of market expansion[1].

Market Segments

By Drug Class

The oncology drugs market is segmented by drug class, with cytotoxic drugs currently holding the dominant position. However, targeted therapies are expected to surpass cytotoxic drugs by 2031 due to their growing clinical evidence and potential[1].

By Therapy

Chemotherapy is the largest segment currently, but targeted therapy and immunotherapy segments are expected to exhibit significant growth rates. This is due to the development of novel mechanisms and drugs in these classes[1].

Financial Trajectory

Revenue Forecast

The oncology drugs market is forecasted to grow significantly, driven by the increasing prevalence of cancer and the rising demand for innovative treatments. The market is expected to reach $532.91 billion by 2031, up from $231.56 billion in 2024[1].

Cost and Pricing Dynamics

The cost of oncology drugs can be substantial, with drugs like KEYTRUDA having a list price of $11,564.16 for a 200 mg dose given every 3 weeks. However, patient out-of-pocket costs can vary widely depending on insurance coverage and financial support options[5].

Challenges and Opportunities

High Development Costs

The development of oncology drugs is highly costly, which can be a significant barrier to entry for new players in the market. High development costs also impact the pricing of these drugs, making them less accessible to some patients[1].

Stringent Government Regulations

Stringent government regulations can slow down the approval process for new drugs, affecting market growth. However, these regulations also ensure the safety and efficacy of the drugs, which is crucial for patient health[1].

Opportunities for Cost Savings

Changes in drug distribution models can have significant financial impacts on health systems. For instance, shifting administrations from inpatient to outpatient settings can help offset increased expenditures due to distribution model changes[2].

Impact of Generic Drugs

Price Trajectories

Generic drugs, which account for over 90% of all drugs sold in the US, exhibit various price trajectories. While most generic drugs show slow or rapid declines in price, around 17% experience rapid price increases. Understanding these trajectories is crucial for managing drug costs effectively[3].

Technological Advancements

Modernization of Drug Delivery Technologies

The pharmaceutical drug delivery market, closely related to oncology, is driven by technological advancements. Modern drug delivery technologies focus on patient comfort, compliance, and the efficiency of medication delivery. These advancements are expected to support the growth of the oncology drugs market as well[4].

Government Initiatives and Reimbursement Policies

Government initiatives to provide affordable drug delivery products and supportive reimbursement policies are critical in driving market growth. These policies help in improving access to pharmacological therapies for patients, particularly those with chronic conditions like cancer[4].

Patient Preferences and Geriatric Population

The growing geriatric population and patient preference for home-based care are also significant drivers. As the population ages, the demand for more efficient and comfortable medication delivery methods increases, contributing to market growth[4].

Key Takeaways

• The oncology drugs market is expected to grow significantly, driven by the increasing prevalence of cancer and the adoption of targeted therapies and immunotherapies.
• Technological advancements in drug delivery systems and government initiatives are crucial for market growth.
• High development costs and stringent government regulations are key challenges.
• Understanding price trajectories of generic drugs and shifting administration settings can help in cost management.
• Patient preferences and the growing geriatric population are important factors influencing market dynamics.

FAQs

What is the projected growth rate of the global oncology drugs market?

The global oncology drugs market is projected to grow at a CAGR of 12.6% from 2024 to 2031[1].

What are the main drivers of the oncology drugs market?

The main drivers include the increasing prevalence of cancer, adoption of targeted therapies and immunotherapies, and advancements in drug delivery systems[1].

How do changes in drug distribution models impact health systems financially?

Changes in drug distribution models can increase drug expenditures for health systems, but shifting administrations from inpatient to outpatient settings can help offset these costs[2].

What role do generic drugs play in the pharmaceutical market?

Generic drugs account for over 90% of all drugs sold in the US and exhibit various price trajectories, with most showing slow or rapid declines in price, while some experience rapid price increases[3].

How do government initiatives impact the oncology drugs market?

Government initiatives to provide affordable drug delivery products and supportive reimbursement policies improve access to pharmacological therapies, driving market growth[4].

Cited Sources:

1. Coherent Market Insights, "Oncology Drugs Market to Reach USD 532.91 Billion by 2031".
2. PubMed, "Financial Effect of a Drug Distribution Model Change on a Health System".
3. Econstor, "Trajectories of prices in generic drug markets: What can we infer from the data?"
4. MarketsandMarkets, "Pharmaceutical Drug Delivery Market Growth, Drivers & Opportunities".
5. Merck, "Cost, Insurance, & Financial Help With KEYTRUDA® (pembrolizumab)".