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Last Updated: April 15, 2025

FEMSTAT 3 Drug Patent Profile


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When do Femstat 3 patents expire, and when can generic versions of Femstat 3 launch?

Femstat 3 is a drug marketed by Bayer and is included in one NDA.

The generic ingredient in FEMSTAT 3 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.

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Summary for FEMSTAT 3
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 105
Patent Applications: 1,055
DailyMed Link:FEMSTAT 3 at DailyMed
Drug patent expirations by year for FEMSTAT 3

US Patents and Regulatory Information for FEMSTAT 3

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bayer FEMSTAT 3 butoconazole nitrate CREAM;VAGINAL 020421-001 Dec 21, 1995 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for FEMSTAT 3

Introduction

FEMSTAT 3, a prescription drug used for the treatment of vaginal yeast infections, operates within a complex and dynamic pharmaceutical market. To understand its market dynamics and financial trajectory, it is essential to analyze various factors influencing its position and performance.

Market Context

The pharmaceutical market, particularly for antifungal and women's health products, is driven by several key factors:

Increasing Demand for Specialized Treatments

The growing prevalence of chronic and specialized conditions, such as vaginal yeast infections, drives the demand for effective treatments. This is evident in the U.S. drug utilization management market, which is anticipated to reach USD 60.68 billion by 2030, with a CAGR of 7.30% from 2024 to 2030[3].

Cost Containment Efforts

Healthcare organizations and payers are increasingly implementing strategies to manage drug spending, such as restricting drug formularies and raising patient cost-sharing requirements. This can impact the financial trajectory of drugs like FEMSTAT 3[3].

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics of prescription drugs. Approvals, switches from prescription to over-the-counter (OTC), and regulatory changes can significantly affect a drug's market position and revenue[1][4].

Competitive Landscape

The market for antifungal treatments, particularly those targeting vaginal yeast infections, is competitive. Here are some key points:

Existing Treatments

Other antifungal drugs, such as fluconazole, have established market presence and may compete directly with FEMSTAT 3. The success of these drugs can influence the market share and financial performance of FEMSTAT 3.

New Entrants and Innovations

New drugs and treatments, such as those developed by companies like SCYNEXIS, which are focusing on innovative antifungal agents, can pose a competitive threat to established products like FEMSTAT 3[2].

Financial Performance Indicators

To assess the financial trajectory of FEMSTAT 3, several indicators are crucial:

Revenue and Sales

The revenue generated by FEMSTAT 3 would be influenced by its market share, pricing, and the overall demand for antifungal treatments. For example, the total prescription antihistamine market, which is a different segment but indicative of market dynamics, was approximately $4.69 billion in 2001, with significant growth driven by key products[1].

Research and Development Expenses

Companies investing in drugs like FEMSTAT 3 typically incur significant research and development (R&D) expenses. For instance, SCYNEXIS reported R&D expenses of $8.1 million in Q3 2024, highlighting the ongoing investment in drug development[2].

Marketing and Advertising

Direct-to-consumer (DTC) marketing and physician-oriented marketing can significantly impact a drug's sales. The deregulation of DTC marketing has enhanced competition and facilitated market growth for prescription drugs transitioning to OTC status[4].

Market Drivers and Restraints

Several factors drive and restrain the market for FEMSTAT 3:

Market Drivers

  • Increasing Demand for Specialized Treatments: Growing prevalence of vaginal yeast infections drives the demand for effective treatments.
  • Cost Containment Efforts: While cost containment measures can be a restraint, they also drive the need for cost-effective treatments.
  • Regulatory Approvals: Favorable regulatory environments can facilitate market growth[3].

Market Restraints

  • Regulatory and Privacy Issues: Strict regulations and privacy concerns can hinder the market growth of prescription drugs.
  • Competition from Existing Treatments: Established treatments can make it challenging for new drugs to gain market share[3].

Case Studies and Analogies

The transition of drugs from prescription to OTC status can provide valuable insights. For example, the switch of loratadine (Claritin) from prescription to OTC status significantly impacted the antihistamine market, leading to a projected market size increase of 36.6% for the antihistamine component by 2005[1].

Expert Insights and Statistics

Industry experts emphasize the importance of nonprice competition in the pharmaceutical market. For instance:

"The recent deregulation of Rx DTC marketing enhances rivalry and facilitates competition"[4].

Statistics also highlight the growing market:

"The U.S. drug utilization management market size is anticipated to reach USD 60.68 billion by 2030, exhibiting a CAGR of 7.30% from 2024 to 2030"[3].

Financial Projections and Cash Runway

For a drug like FEMSTAT 3, financial projections would involve estimating revenue, expenses, and cash flow. Companies in the pharmaceutical sector often have a significant cash runway to support ongoing R&D and marketing efforts. For example, SCYNEXIS ended Q3 2024 with $84.9 million in cash, cash equivalents, and investments, providing a cash runway into Q3 2026[2].

Key Takeaways

  • Market Demand: Growing demand for specialized treatments drives the market for drugs like FEMSTAT 3.
  • Regulatory Environment: Favorable regulatory changes can significantly impact market dynamics.
  • Competitive Landscape: The market is competitive, with existing treatments and new innovations posing challenges.
  • Financial Performance: Revenue, R&D expenses, and marketing efforts are crucial indicators of financial trajectory.
  • Market Drivers and Restraints: Factors such as cost containment efforts, regulatory approvals, and competition influence market growth.

FAQs

Q: What are the key drivers of the market for antifungal treatments like FEMSTAT 3? A: The key drivers include increasing demand for specialized treatments, cost containment efforts, and favorable regulatory environments.

Q: How does the transition from prescription to OTC status impact a drug's market dynamics? A: This transition can significantly increase market size and revenue, as seen in the case of loratadine (Claritin)[1].

Q: What role does direct-to-consumer marketing play in the pharmaceutical market? A: DTC marketing enhances competition and facilitates market growth by increasing consumer awareness and demand[4].

Q: How do regulatory changes affect the financial trajectory of prescription drugs? A: Regulatory changes can impact market dynamics by affecting approval processes, competition, and overall market growth[1][4].

Q: What are the typical financial indicators for assessing the performance of a prescription drug? A: Key indicators include revenue, R&D expenses, marketing expenses, and cash flow[2].

Cited Sources

  1. Harrington, P., & Shepherd, M. D. (2002). Analysis of the Movement of Prescription Drugs to Over-the-Counter Status. Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas at Austin.
  2. SCYNEXIS. (2024). SCYNEXIS Reports Third Quarter 2024 Financial Results and Provides Corporate Update.
  3. ResearchAndMarkets.com. (2024). U.S. Drug Utilization Management Market Size, Share & Trends Analysis Report 2024-2030.
  4. Kyle, M. (2002). Deregulating Direct-to-Consumer Marketing of Prescription Drugs. Journal of Law and Economics.

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