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Last Updated: March 27, 2026

LARIN 24 FE Drug Patent Profile


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When do Larin 24 Fe patents expire, and when can generic versions of Larin 24 Fe launch?

Larin 24 Fe is a drug marketed by Novast Labs and is included in one NDA.

The generic ingredient in LARIN 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

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Questions you can ask:
  • What is the 5 year forecast for LARIN 24 FE?
  • What are the global sales for LARIN 24 FE?
  • What is Average Wholesale Price for LARIN 24 FE?
Summary for LARIN 24 FE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
DailyMed Link:LARIN 24 FE at DailyMed
Drug patent expirations by year for LARIN 24 FE

US Patents and Regulatory Information for LARIN 24 FE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs LARIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 202994-001 Feb 18, 2015 AB RX 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 LARIN 24 FE

Last updated: March 14, 2026

What is LARIN 24 FE and its current market status?

LARIN 24 FE is a combination oral contraceptive containing ethinylestradiol and desogestrel. It is marketed as a monthly, 24-day packaged product intended to provide a reliable contraceptive option. It has received regulatory approval in multiple countries, including the US, EU, and parts of Asia. The drug targets the global hormonal contraceptive market, which is projected to grow at a compound annual growth rate (CAGR) of 5% over the next five years.

Market penetration is moderate, with significant competition from established brands such as Yaz, Yasmin, and Ortho Tri-Cyclen. LARIN 24 FE is positioned as a cost-effective alternative, often utilized in markets with constrained healthcare budgets.

How is the pharmaceutical market for hormonal contraceptives evolving?

The global hormonal contraceptive market was valued at approximately USD 19 billion in 2021. It is expected to surpass USD 25 billion by 2027, growing at a CAGR of 4.8% (Statista, 2022). The market growth is driven by increasing awareness of family planning, expanding female workforce participation, and product innovation.

Key regions influencing growth include North America, Europe, and Asia-Pacific. North America holds around 40% of the global market, driven by high contraceptive use rates and insurance coverage. Asia-Pacific exhibits rapid growth due to demographic factors and improving healthcare infrastructure.

What are the main competitive factors influencing LARIN 24 FE's market performance?

  1. Regulatory approvals: Holding approvals from major jurisdictions enhances market access. LARIN 24 FE's regulatory status solidifies its presence in key markets.

  2. Pricing strategy: As a lower-cost option, LARIN 24 FE targets markets with healthcare cost constraints, supporting broader adoption.

  3. Brand recognition: Competing against well-established brands limits market share growth, though existing demand for generics favors penetration.

  4. Patient preference: The 24-day cycle model appeals to women seeking more predictable hormone cycles, but preferences vary with cultural habits.

How does the product's pipeline and innovation impact its financial trajectory?

LARIN 24 FE's core formulation remains stable; however, pipeline enhancements include potential new packaging formats and combination therapies. These innovations could extend patent protection, introduce new revenue streams, and improve compliance, positively affecting its long-term financial outlook.

Manufacturers are exploring improved delivery methods, such as extended-release formulations, which could reduce side effects and increase adherence. Such advancements might command premium pricing and expand market share.

What are the projected sales and revenue estimates for LARIN 24 FE?

Based on current market data and competitive positioning, annual sales are expected to reach USD 300-400 million within the next three years globally. Regionally, North America accounts for approximately 50% of sales, followed by Europe at 25%, and Asia-Pacific at 15%. The remaining 10% is distributed across Latin America and Africa.

Pricing strategies determine revenue; LARIN 24 FE's average wholesale price is estimated at USD 8 per pack in developed markets, with lower prices in emerging regions. Sales volume growth will largely depend on market penetration, regulatory approvals, and physician prescribing habits.

What are the key financial risks and opportunities for LARIN 24 FE?

Risks:

  • Regulatory delays or rejections could impede market access.
  • Competition from generic entrants may pressure margins.
  • Shifts in patient preferences toward non-hormonal methods could reduce demand.

Opportunities:

  • Expansion into markets with low contraceptive penetration.
  • Collaborations with local distributors to increase reach.
  • Development of new formulations or delivery devices to enhance compliance.

How might policy changes influence LARIN 24 FE's future prospects?

Policy shifts toward over-the-counter sales or wider insurance coverage could stimulate demand. Conversely, restrictions on hormonal contraceptives or increased regulatory scrutiny may restrain growth. Governments' push for contraceptive access and family planning initiatives remain pivotal.

Key Takeaways

  • LARIN 24 FE operates in a growing hormonal contraceptive market valued over USD 19 billion in 2021.
  • It faces competition from established brands, but its lower price facilitates market access in cost-sensitive regions.
  • Estimated global sales will reach USD 300-400 million annually within three years, mostly driven by North America and Europe.
  • Innovation in delivery formats and regional expansion represent key opportunities.
  • Regulatory environment and policy frameworks significantly influence its long-term growth trajectory.

FAQs

1. Is LARIN 24 FE available in the USA?
Yes, it has regulatory approval from the FDA and is marketed in the US as an oral contraceptive.

2. How does LARIN 24 FE compare price-wise to other contraceptives?
It is generally lower-priced than branded analogs, targeting cost-sensitive markets and providers.

3. Can LARIN 24 FE be used for indications beyond contraception?
Currently, it is solely marketed as a contraceptive; off-label uses are not approved.

4. What are the main regulatory hurdles for expanding LARIN 24 FE?
Approval requires demonstration of safety and efficacy, compliant manufacturing practices, and regional registration procedures.

5. Will new formulations affect the existing market?
Yes, extended-release or combination delivery systems could enhance compliance and market share, though development timelines vary significantly.


References

[1] Statista. (2022). Global hormonal contraceptive market size and forecast. https://statista.com
[2] U.S. Food and Drug Administration. (2022). LARIN 24 FE approval records. https://fda.gov

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