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Last Updated: March 26, 2026

AUROVELA 24 FE Drug Patent Profile


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Which patents cover Aurovela 24 Fe, and what generic alternatives are available?

Aurovela 24 Fe is a drug marketed by Aurobindo Pharma and is included in one NDA.

The generic ingredient in AUROVELA 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 AUROVELA 24 FE?
  • What are the global sales for AUROVELA 24 FE?
  • What is Average Wholesale Price for AUROVELA 24 FE?
Summary for AUROVELA 24 FE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
DailyMed Link:AUROVELA 24 FE at DailyMed
Drug patent expirations by year for AUROVELA 24 FE

US Patents and Regulatory Information for AUROVELA 24 FE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma AUROVELA 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 207504-001 Jun 15, 2017 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 AUROVELA 24 FE

Last updated: February 24, 2026

What is AUROVELA 24 FE?

AUROVELA 24 FE is a combination oral contraceptive marketed primarily in India and developed by the pharmaceutical company Mankind Pharma. It contains drospirenone and ethinylestradiol, used for preventing pregnancy. The "24 FE" denotes a 24-day active pill regimen with a 4-day break, differing from traditional 21-day courses.

Market Size and Growth Drivers

Global and India-Specific Market Overview

  • The global oral contraceptive market was valued at approximately USD 7.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.9% through 2030 (Grand View Research, 2023).
  • India represents a significant portion of this market, accounting for an estimated USD 1.8 billion in 2022 and expected to grow at a CAGR of 6.2% (ResearchAndMarkets.com, 2023).

Drivers Specific to AUROVELA 24 FE

  • Product Differentiation: The 24-day active regimen aligns with patient preferences for reduced hormonal intake.
  • Regulatory Approvals: Approved by the Drugs Controller General of India (DCGI) in 2018.
  • Market Penetration: As a branded product, it targets urban and semi-urban segments with higher awareness levels.
  • Physician Preference: Favorable prescribing trends for fixed-dose combinations with better side effect profiles.

Competitive Landscape

Major Competitors

  • Yasmin (Bayer): A well-established product with a market share estimated at 35-40% in India.
  • Diane-35 (Bayer): Also common for contraception and therapeutic indications.
  • Other Local Brands: Popularity driven by price competitiveness and physician recommendation.

Unique Position of AUROVELA 24 FE

  • Offers a 24-day active pill cycle, reducing hormone withdrawal symptoms.
  • Slightly higher pricing but is perceived as more convenient.
  • Limited direct competitors with similar dosing schedules.

Regulatory and Policy Environment

  • India’s Central Drugs Standard Control Organization (CDSCO) updated guidelines in 2018 allowing fixed-dose combinations (FDCs), including drospirenone-based pills.
  • Imposing restrictions and requiring efficacy and safety data for marketing approvals.
  • Patent protections for drospirenone-based formulations expired in key markets, encouraging generic competition.

Financial Trajectory

Revenue and Sales

  • Estimated Indian sales revenue: USD 20 million in 2022.
  • Projected annual growth rate: 12% over the next 3-5 years, driven by increased awareness and expanding urban markets.
  • Pricing remains competitive, with average retail prices around USD 1.2 per pack.

Market Share Trends

  • Mankind Pharma's AUROVELA 24 FE has secured approximately 10% of the oral contraceptive market in India as of 2022.
  • The larger share is maintained through aggressive marketing, physician engagement, and distribution channels.

Investment and R&D Outlook

  • Mankind Pharma invests in brand extensions, new formulations, and clinical trials.
  • Expect incremental R&D spending to improve efficacy profiles and reduce side effects, enhancing market share.
  • Potential for expanding into nearby Southeast Asian markets following regulatory approvals.

Future Outlook

  • Growth driven by increasing contraceptive awareness, family planning policies, and urbanization.
  • Emergence of generic competitors could pressure pricing.
  • Regulatory trends favoring newer combinations and delivery systems.
  • Digital marketing and telehealth adoption will bolster product reach.

Risks and Challenges

  • Regulatory policy shifts may restrict certain formulations.
  • Price competition from generics could erode margins.
  • Cultural factors influencing acceptance, especially in rural markets.
  • Patent expirations could increase competition, reducing profitability.

Key Data Summary

Parameter 2022 Data Expected Trend (2023–2027)
Global contraceptive market size USD 7.4 billion CAGR 4.9%
India contraceptive market size USD 1.8 billion CAGR 6.2%
AUROVELA 24 FE sales revenue USD 20 million +12% annually
Market share in India Approximately 10% Stable to slight increase
Average retail price per pack USD 1.2 Nominal increase

Key Takeaways

  • AUROVELA 24 FE holds a niche in the India's evolving oral contraceptive market, with growth driven by product differentiation and urban expansion.
  • Competitive pressure via generics and pricing strategies remains a critical factor.
  • Regulatory developments are favorable for newer formulations but require ongoing compliance.
  • Revenue growth is expected to stay steady, supported by increased awareness and family planning initiatives.
  • The product’s future depends on maintaining regulatory compliance, competitive pricing, and expanding distribution.

FAQs

Q1: How does AUROVELA 24 FE compare to traditional contraceptive pills?
It offers a 24-day active pill cycle with a 4-day break, reducing hormonal fluctuations and withdrawal bleeding. This differs from standard 21/7 regimens.

Q2: What are the main risks for AUROVELA 24 FE's market growth?
Generic competition, regulatory restrictions, and pricing pressures could limit growth. Poor acceptance in rural areas may also affect market penetration.

Q3: Are there patent protections for AUROVELA 24 FE?
No, patents for drospirenone-based combinations expired in major markets like India, enabling generics to enter with similar formulations.

Q4: What is the regulatory environment’s impact on future sales?
Stringent approval processes and ongoing policy updates may delay new formulations but also create opportunities for approved, proven products.

Q5: What strategic moves could enhance AUROVELA 24 FE’s market position?
Expanding into nearby markets, engaging in clinical trials for safety claims, and differentiating through user experience can bolster market share.


References

  1. Grand View Research. (2023). Oral Contraceptive Market Size, Share & Trends Analysis Report.
  2. ResearchAndMarkets.com. (2023). India Contraceptives Market Outlook.

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