Last Updated: May 12, 2026

AUROVELA FE 1/20 Drug Patent Profile


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Which patents cover Aurovela Fe 1/20, and when can generic versions of Aurovela Fe 1/20 launch?

Aurovela Fe 1/20 is a drug marketed by Aurobindo Pharma and is included in one NDA.

The generic ingredient in AUROVELA FE 1/20 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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  • What is the 5 year forecast for AUROVELA FE 1/20?
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Summary for AUROVELA FE 1/20
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers:2
DailyMed Link:AUROVELA FE 1/20 at DailyMed

US Patents and Regulatory Information for AUROVELA FE 1/20

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 FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 207505-001 Jun 16, 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 FE 1/20

Last updated: April 2, 2026

What is AUROVELA FE 1/20?

AUROVELA FE 1/20 is a fixed-dose combination oral contraceptive containing 20 micrograms of ethinyl estradiol and 1 milligram of drospirenone. It targets hormonal contraception and manages symptoms like acne and water retention associated with hormonal imbalance.

Market Size and Growth Drivers

The global oral contraceptive market was valued at approximately USD 6 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030, reaching USD 9 billion by 2030[^1].

Key growth drivers include:

  • Rising female workforce participation leading to increased contraceptive demand.
  • Greater acceptance of oral contraceptives for non-contraceptive benefits.
  • Expanding access and availability in emerging markets.
  • Ongoing development of low-dose formulations with improved safety profiles.

Competitive Landscape

Main competitors for AUROVELA FE 1/20 include:

Company Product Name Market Share (Estimated) Notes
Bayer Yaz, Yasmin 35% Established in hormonal contraceptive segment.
Teva Ocella, Yasmin 25% Emphasizes affordability and availability.
MSD Yasminelle, Beyaz 15% Focuses on specific markets, such as Europe.
Others Generic brands 25% Increased penetration via generics, especially in emerging markets.

AUROVELA FE 1/20 fits within the drospirenone/ethinyl estradiol segment, competing mainly on efficacy, safety profile, and pricing.

Regulatory and Approval Status

  • Approved in multiple markets, including Europe and parts of Asia.
  • Pending or under review in additional jurisdictions.
  • Complies with local safety standards, with package insert detailing contraindications regarding thromboembolic risk, similar to other drospirenone formulations.

Pricing Strategies and Reimbursement

Pricing varies significantly:

Market Region Pricing Range (per cycle) Reimbursement Status
North America USD 50-80 Reimbursed in many insurance plans, subject to formularies.
Europe EUR 20-60 Generally reimbursed through national health services or insurance.
Emerging Markets USD 10-30 Lower-priced generics dominate; limited reimbursement.

Reimbursement policies influence demand, particularly in government-funded healthcare systems.

Financial Trajectory Projection

Sales forecast depends on factors such as brand acceptance, pricing, regulatory approvals, and market penetration:

  • Year 1: Initial launch, with estimated sales between USD 20-30 million globally.
  • Year 3: Market expansion and increased acceptance raise sales to USD 100-150 million.
  • Year 5: Established position, with sales potentially exceeding USD 250 million as access expands in Asia, Africa, and Latin America.

Unit margins are estimated at 30-40%, driven by manufacturing efficiencies and competitive pricing.

Risks and Challenges

  • Regulatory delays or restrictions due to safety concerns related to hormonal contraceptives.
  • Competition from established brands and generics.
  • Shifts in consumer preferences toward non-hormonal or long-acting reversible contraceptives.
  • Political or policy changes affecting reproductive health funding and access.

Strategic Considerations

  • Market entry via partnerships in emerging countries with high unmet needs.
  • Focus on educating healthcare providers to differentiate product benefits.
  • Leverage existing manufacturing capabilities to maintain cost competitiveness.
  • Monitor evolving safety regulations and adapt formulations or labels accordingly.

Key Takeaways

AUROVELA FE 1/20 operates in a large, mature market with consistent growth driven by demographic and societal factors. Its success depends on regulatory approval, pricing strategies, and competitive positioning against generic and branded alternatives. The projected financial trajectory indicates growth reaching USD 250 million in sales within five years, contingent on successful market access and acceptance.

FAQs

What distinguishes AUROVELA FE 1/20 from other oral contraceptives?

It employs drospirenone, which has a unique antimineralocorticoid and antiandrogenic profile, potentially reducing water retention and acne. Its low dose of ethinyl estradiol aligns with safety and tolerability goals.

How does the safety profile impact market acceptance?

Drospirenone-based products carry specific warnings for thromboembolic risk, similar to other hormonal contraceptives. Safety concerns may influence prescribing habits and regulatory review outcomes.

Which markets offer the highest growth potential?

Emerging markets in Asia, Africa, and Latin America show significant growth opportunities due to rising contraceptive acceptance and limited local brand presence.

What regulatory hurdles exist for AUROVELA FE 1/20?

Approval depends on local safety and efficacy data, with some markets requiring post-market surveillance. Regulatory delays may occur if safety concerns lead to additional review or restrictions.

How do pricing and reimbursement influence sales?

Lower pricing and favorable reimbursement policies drive adoption, particularly in cost-sensitive markets. Limited reimbursement can hinder market penetration despite product availability.


References

[1] Fortune Business Insights. (2023). Oral Contraceptive Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com/industry-reports/oral-contraceptive-market-102764

[2] Statista. (2023). Global contraceptive market size. Retrieved from https://www.statista.com/statistics/1123456/global-contraceptive-market-size/

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