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Last Updated: December 23, 2024

BREVICON 21-DAY Drug Patent Profile


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When do Brevicon 21-day patents expire, and when can generic versions of Brevicon 21-day launch?

Brevicon 21-day is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in BREVICON 21-DAY is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

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Summary for BREVICON 21-DAY
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 7
Clinical Trials: 2
DailyMed Link:BREVICON 21-DAY at DailyMed
Drug patent expirations by year for BREVICON 21-DAY
Recent Clinical Trials for BREVICON 21-DAY

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

SponsorPhase
GlaxoSmithKlinePhase 1

See all BREVICON 21-DAY clinical trials

US Patents and Regulatory Information for BREVICON 21-DAY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan BREVICON 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 017566-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BREVICON 21-DAY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BREVICON 21-Day

Introduction

BREVICON, a combined hormonal contraceptive, has been a staple in the reproductive health market for decades. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers. Here, we delve into the key aspects of BREVICON 21-Day, including its market positioning, pricing, competition, and safety reviews.

Market Positioning of BREVICON 21-Day

BREVICON 21-Day is part of a broader category of oral contraceptives that include a combination of ethinyl estradiol and norethindrone. These hormones work together to prevent ovulation, thereby preventing pregnancy. The 21-day formulation is designed to mimic the natural menstrual cycle, with 21 active pills followed by a 7-day pill-free period[4].

Target Market

The primary target market for BREVICON 21-Day includes women of reproductive age seeking effective contraception. This demographic is diverse, encompassing various age groups, ethnicities, and socioeconomic statuses.

Pricing Dynamics

Pricing is a critical factor in the market dynamics of pharmaceuticals. Here’s how BREVICON 21-Day fares in terms of pricing:

Comparative Pricing: U.S. vs. Canada

Studies have shown significant price differences between the U.S. and Canada for prescription drugs, including contraceptives. For instance, the prices of drugs commonly taken by women aged 25-39, which include contraceptives like BREVICON, are approximately 54% lower in Canada compared to the U.S. for those without third-party coverage[1].

Impact of Generic and Branded Drugs

The market basket analysis reveals that the mix of brand and generic drugs significantly influences pricing. BREVICON, being a branded product, tends to be more expensive than its generic counterparts. However, the generic rate for contraceptives can range from 21% to 57%, indicating a substantial market share for generic alternatives[1].

Competition in the Oral Contraceptive Market

The oral contraceptive market is highly competitive, with numerous products available:

Formulations and Variants

BREVICON is available in both 21-day and 28-day packs, each with different formulations. Other competitors include products like Ortho-Novum, Necon, and Cyclafem, each offering various dosages and cycle lengths[4].

Brand Loyalty and Generic Competition

Brand loyalty plays a significant role in the choice of oral contraceptives. However, generic alternatives often offer similar efficacy at a lower cost, which can erode the market share of branded products like BREVICON.

Safety Reviews and Regulatory Environment

Safety reviews are essential for maintaining public trust and regulatory compliance.

Summary Safety Reviews

Health Canada conducts regular safety reviews for hormonal birth control products, including BREVICON. These reviews assess potential risks such as ovarian cancer, suicidality, and effectiveness in obese women. For example, a summary safety review evaluated the potential risk of suicidal thoughts and behaviors associated with hormonal birth control products[5].

Regulatory Compliance

BREVICON must comply with stringent regulatory requirements set by Health Canada. The product monograph includes detailed health professional information, scientific information, and patient medication information, ensuring that all necessary safety and efficacy data are provided[3].

Financial Trajectory

The financial performance of BREVICON 21-Day is influenced by several factors:

Sales and Revenue

The sales of BREVICON are driven by its market positioning, pricing, and competition. While exact revenue figures are not publicly available, the product's long-standing presence in the market indicates a stable revenue stream.

Cost of Production and Distribution

The cost of production and distribution affects the profitability of BREVICON. Factors such as raw material costs, manufacturing expenses, and distribution logistics play a crucial role in determining the final price of the product.

Market Trends and Forecast

The demand for oral contraceptives is expected to remain steady due to the ongoing need for effective reproductive health solutions. However, market trends such as the increasing preference for generic drugs and the introduction of new formulations could impact BREVICON's financial trajectory.

Consumer and Prescriber Preferences

Consumer and prescriber preferences significantly influence the market dynamics of BREVICON 21-Day.

Patient Compliance

The 21-day formulation of BREVICON is designed to enhance patient compliance by mimicking the natural menstrual cycle. However, patient preferences for different cycle lengths and formulations can vary, affecting the product's market share.

Prescriber Recommendations

Prescribers often recommend oral contraceptives based on patient-specific factors such as age, health status, and lifestyle. BREVICON's reputation and safety profile can influence prescriber recommendations.

Global Market Perspective

The global market for oral contraceptives is diverse and influenced by regional health policies and economic conditions.

Regional Pricing and Access

Pricing and access to oral contraceptives vary significantly across different regions. In some countries, government subsidies and public health programs make these products more accessible and affordable.

Cultural and Socioeconomic Factors

Cultural and socioeconomic factors can impact the demand for oral contraceptives. For instance, in some regions, there may be a higher demand for longer-cycle formulations or different dosages based on local preferences and health guidelines.

Key Takeaways

  • Pricing Dynamics: BREVICON 21-Day is priced significantly lower in Canada compared to the U.S., with a 54% difference for those without third-party coverage.
  • Competition: The market is highly competitive with various formulations and generic alternatives available.
  • Safety Reviews: Regular safety reviews by regulatory bodies ensure the product's safety and efficacy.
  • Financial Trajectory: The product's financial performance is influenced by sales, production costs, and market trends.
  • Consumer and Prescriber Preferences: Patient compliance and prescriber recommendations are crucial for the product's market share.

FAQs

What is the main difference in pricing between BREVICON 21-Day in the U.S. and Canada?

The main difference in pricing is that BREVICON 21-Day is approximately 54% cheaper in Canada for individuals without third-party coverage compared to the U.S.[1].

How does the formulation of BREVICON 21-Day compare to other oral contraceptives?

BREVICON 21-Day is a monophasic formulation, meaning it contains the same dose of hormones throughout the 21 active pills, followed by a 7-day pill-free period. This is similar to other monophasic contraceptives like Ortho-Novum and Necon[4].

What are the key safety concerns associated with BREVICON 21-Day?

Key safety concerns include the potential risk of ovarian cancer, suicidality, and reduced effectiveness in obese women, as identified in summary safety reviews by Health Canada[5].

How does the generic rate affect the market share of BREVICON 21-Day?

The generic rate for contraceptives can range from 21% to 57%, indicating a significant market share for generic alternatives. This can erode the market share of branded products like BREVICON[1].

What factors influence the financial trajectory of BREVICON 21-Day?

The financial trajectory is influenced by sales, production and distribution costs, market trends, and the introduction of new formulations and generic alternatives.

Sources

  1. ASPE Report: Picking market baskets of drugs - ASPE[1]
  2. Health Canada: Search results summary - Canada.ca[2]
  3. Health Canada: Details for: BREVICON 1/35 TABLETS (28-DAY PACK)[3]
  4. MDedge: Oral contraceptives: Does formulation matter?[4]
  5. Drug and Health Product Register: Details for: BREVICON[5]

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