Last Updated: May 3, 2026

BREVICON 28-DAY Drug Patent Profile


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When do Brevicon 28-day patents expire, and when can generic versions of Brevicon 28-day launch?

Brevicon 28-day is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in BREVICON 28-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 28-DAY
Recent Clinical Trials for BREVICON 28-DAY

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SponsorPhase
GlaxoSmithKlinePhase 1

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US Patents and Regulatory Information for BREVICON 28-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 28-DAY ethinyl estradiol; norethindrone TABLET;ORAL-28 017743-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for BREVICON 28-DAY

Last updated: March 19, 2026

What is BREVICON 28-DAY?

Breviclon 28-day is a broad-spectrum oral contraceptive comprising ethinyl estradiol and norethindrone. Its primary indication is contraception, competing with other combination oral contraceptives (COCs) in a mature market. It is marketed as an effective and easy-to-use option for women seeking long-term pregnancy prevention.

Market Overview

Global Contraceptive Market

The global contraceptive market was valued at approximately $22.4 billion in 2022, with a compound annual growth rate (CAGR) of 6.7% projected through 2027 [1]. Oral contraceptives (OCs) account for the majority of sales, representing roughly 55-60% of the market share, driven by established efficacy, convenience, and patient preference.

Key Competitors

Leading brands include:

  • Yaz/Yasmin (Bayer)
  • Ortho Tri-Cyclen (Bayer)
  • Loestrin (Solve)
  • Alesse (Teva)

These products command significant market shares due to longstanding presence, physician familiarity, and extensive marketing.

Market Entry Factors for BREVICON 28-DAY

  • Regulatory approval status in major markets (e.g., FDA, EMA) is essential.
  • Manufacturing capacity must meet demand projections.
  • Brand differentiation depends on unique formulations or dosing convenience.

Growth Drivers

  • Increasing awareness of reproductive health among women aged 15–45.
  • Surge in contraceptive use in emerging markets, notably Asia-Pacific and Latin America.
  • Shift toward oral contraceptives over barrier methods due to convenience.
  • Capitalize on formulary inclusion and insurance coverage in developed markets.

Challenges and Market Risks

  • Market saturation: Many established brands reduce room for new entrants.
  • Pricing pressures: Intense competition drives aggressive pricing strategies.
  • Regulatory hurdles: New formulations require costly clinical trials.
  • Patent expiry and generic competition: Major brands are losing patent protection, risking erosion of market share [2].

Financial Trajectory

Revenue Projections

Assuming BREVICON 28-DAY secures regulatory approval and achieves an initial market penetration of approximately 2-3% in key markets within three years:

Year Estimated Revenue (USD millions) Key Assumptions
2023 0.0 (pre-market) Awaiting regulatory approval
2024 10–15 Launch in North America, moderate uptake
2025 35–50 Expansion into Europe, increased prescribing
2026 70–100 Broader worldwide adoption, stable market share

Cost Structure

  • Research and Development (R&D): Initial investments likely exceeding $100 million for clinical trials and regulatory filings.
  • Manufacturing: Costs expected to be around $2–3 per unit, with scale efficiencies reducing per-unit costs over time.
  • Marketing: Launch campaigns estimated at $10–15 million annually initially, decreasing as brand recognition increases.

Pricing Strategy

Pricing is expected to align with existing COCs, approximately $20–$30 per month per patient, depending on regional market dynamics. Price competitiveness will influence customer adoption, given the strong presence of generic alternatives.

Profitability Outlook

Profit margins for contraceptive products generally range from 25–40%. BREVICON 28-DAY’s profitability hinges on achieving scale, managing manufacturing costs, and securing favorable reimbursement agreements.

Regulatory and Patent Landscape

Patent expiration for key competitors’ formulations has intensified generic competition. BREVICON’s patent status is crucial: if protected until at least 2028, it can sustain higher pricing and market share. Patent challenges or delays could significantly impact revenue timelines.

Strategic Opportunities

  • Partnerships with pharmaceutical distributors and insurances.
  • Market segmentation: Focus on niche segments like women with specific hormonal sensitivities.
  • Expansion into emerging markets where contraceptive use is rising.

Conclusion

With the global contraceptive market expanding, BREVICON 28-DAY has the potential to achieve moderate initial sales, contingent on regulatory approval, effective market access, and pricing strategies. Challenges include fierce competition and patent expirations, which could compress margins and market share over time.

Key Takeaways

  • BREVICON 28-DAY is positioned within a growing contraceptive market primarily driven by oral contraceptive demand.
  • Sales forecast initial years are cautious, with significant growth potential as the product gains market penetration.
  • Revenue projections depend heavily on regulatory approval timing, patent status, and competitive response.
  • Cost structures and pricing strategies will significantly influence profitability.
  • Market risks include patent expiration, generic entry, and pricing competition.

FAQs

1. What distinguishes BREVICON 28-DAY from existing contraceptives?
It offers a specific formulation and dosing schedule aimed at improving compliance, though differentiation from established brands remains a challenge.

2. Which markets are most promising for BREVICON 28-DAY?
North America, Europe, and select emerging markets like Asia-Pacific and Latin America.

3. How does patent protection impact BREVICON’s market potential?
Patent protection allows premium pricing and reduces generic competition; expiry could lead to significant revenue decline.

4. What regulatory hurdles could delay BREVICON’s commercial launch?
Clinical trial compliance, approval processes, and meeting regional safety standards.

5. How significant is the impact of patent expiration in this segment?
Highly significant; patent expiration typically leads to generic competition, reducing prices and margins substantially.


References

[1] Grand View Research. (2022). Contraceptive Market Size, Share & Trends Analysis.
[2] U.S. Patent and Trademark Office. (2022). Patent Expirations and Market Competition Reports.

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