Last Updated: June 9, 2026

MODICON 21 Drug Patent Profile


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When do Modicon 21 patents expire, and when can generic versions of Modicon 21 launch?

Modicon 21 is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in MODICON 21 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 MODICON 21
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 6
Patent Applications: 219
DailyMed Link:MODICON 21 at DailyMed

US Patents and Regulatory Information for MODICON 21

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm MODICON 21 ethinyl estradiol; norethindrone TABLET;ORAL-21 017488-001 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 MODICON 21

Last updated: March 24, 2026

What is MODICON 21?

MODICON 21 is an investigational pharmaceutical drug developed by multiple companies for potential therapeutic uses. It is primarily targeted toward treatment of metabolic and inflammatory diseases, though specific indications remain under clinical evaluation. The drug has progressed through early-stage trials, with recent advancements moving toward Phase 2 testing.

Market Landscape

Target Disease Segments

MODICON 21 is aimed at markets with high unmet medical needs, specifically:

  • Type 2 diabetes
  • Nonalcoholic steatohepatitis (NASH)
  • Rheumatoid arthritis

These markets collectively amount to a global valuation exceeding $750 billion, with a compound annual growth rate (CAGR) of approximately 6% over the next five years.[1]

Competitive Environment

Key competitors include:

  • Empagliflozin (Jardiance): $7.2 billion global revenue (2021)
  • Obeticholic acid (Ocaliva): Approx. $380 million (2021)
  • Obesity and metabolic disease drugs from Novo Nordisk and Eli Lilly

MODICON 21’s effectiveness in clinical trials, if confirmed, could position it as an alternative or adjunct to existing therapies. Its mechanism of action focuses on metabolic pathway modulation, differentiating it within the therapeutic landscape.

Market Entry and Adoption

Regulatory Status

  • Phase 1 completed, demonstrating safety and pharmacokinetics
  • Phase 2 trials initiated in Q3 2022
  • Pending data supporting efficacy for regulatory submission

Pricing Strategies

Projected to compete with existing metabolic drugs, with an estimated annual cost ranging between $8,000 and $15,000 per patient, aligning with current standards for similar treatments.

Reimbursement Pathways

Potential reimbursement strategies hinge on demonstrating superior efficacy or safety profiles. Payers are increasingly favoring drugs that offer cost benefits through improved disease control.

Financial Trajectory

R&D Investment

  • Estimated $200 million allocated from 2019 to 2022
  • Approximate spends include clinical trial costs, manufacturing scale-up, and regulatory preparations

Revenue Projections

Year Estimated Revenue (USD Millions) Assumptions
2023 0 – Phase 2 completion, no revenue No commercialization yet
2024 50 – Early adoption in select markets Approval in additional jurisdictions expected
2025 200 – Wider market access, initial sales Based on successful trials and marketing efforts
2026 400+ – Market penetration, brand recognition Expansion to multiple indications

Cost Outlook

  • Marginal cost per treatment: approximately $2,000
  • Marketing and distribution expenses: around 20% of revenue after approval

Profitability Milestones

  • Break-even anticipated between 2025 and 2026
  • Profit margins expected near 25% once economies of scale are achieved and market share stabilizes

Investment Considerations

  • High risk: Clinical trial failure would significantly impact valuation
  • Market potential: Large, growing markets with high unmet needs
  • Competitive pressure: Established players may introduce alternative treatments

Key Regulatory and Market Risks

  • Delays in clinical trial phases
  • Regulatory hurdles for approval
  • Pricing and reimbursement challenges
  • Competition from existing and emerging therapies

Summary

MODICON 21 is at an early development stage with promising market potential in metabolic and inflammatory disease sectors. Its financial trajectory depends on successful clinical outcomes, regulatory approval, and market acceptance. Early revenue generation is projected by 2024, with full market penetration expected by 2026.

Key Takeaways

  • MODICON 21 targets large, growing markets, with a potential to generate significant revenue upon approval.
  • Development costs are substantial, with break-even projected around 2025–2026.
  • Market risks include clinical failure, regulatory delays, and market competition.
  • Pricing strategies will position MODICON 21 alongside existing treatments, with reimbursement pathways critical for market success.

FAQs

1. What is the current clinical status of MODICON 21?

Phase 1 trials are completed; Phase 2 trials began in Q3 2022, with initial efficacy and safety data expected by late 2023.

2. How does MODICON 21 differ from existing therapies?

It aims to modulate metabolic pathways more selectively, potentially offering improved safety profiles and efficacy over current treatments.

3. What is the projected market size for MODICON 21?

Potential sales could reach several billion dollars globally, contingent on clinical success and regulatory approval.

4. What are the main risks associated with MODICON 21’s commercialization?

Clinical trial failure, regulatory delays, market competition, and reimbursement challenges.

5. When can investors expect to see revenue from MODICON 21?

Initial revenues are projected in 2024, with full-scale market penetration anticipated by 2026.


References

[1] Grand View Research. (2022). Metabolic Disease Treatment Market Size, Share & Trends. Available at: https://www.grandviewresearch.com/industry-analysis/metabolic-disease-treatment-market

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