You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

AUROVELA FE 1/20 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for AUROVELA FE 1/20?
  • What are the global sales for AUROVELA FE 1/20?
  • What is Average Wholesale Price for AUROVELA FE 1/20?
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
Drug patent expirations by year for AUROVELA FE 1/20

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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: July 28, 2025

Introduction

AUROVELA FE 1/20, a combined oral contraceptive (COC) containing estradiol valerate and dienogest, has gained prominence within the contraceptive market segment owing to its innovative formulation and favorable safety profile. As with any pharmaceutical product, understanding its market dynamics and financial trajectory is essential for stakeholders including manufacturers, investors, healthcare providers, and regulatory agencies. This analysis delineates the factors influencing AUROVELA FE 1/20's market growth, key drivers and constraints, competitive landscape, and revenue projections grounded in recent industry trends.

Market Overview

The global contraceptives market was valued at approximately USD 20 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 6% through 2030, driven by increasing awareness, technological advances, and expanding access across emerging markets [1]. AUROVELA FE 1/20, positioned within this landscape, primarily targets women seeking reliable contraception with an emphasis on minimal side effects and adherence ease.

Manufactured by specialized pharmaceutical firms, AUROVELA FE 1/20 leverages the positive reputation of estrogen-progestin combinations while offering improved safety and tolerability profiles. Its unique formulation—estradiol valerate, a bioidentical estrogen, combined with dienogest, a progestin with antiandrogenic properties—aligns with current clinical preferences, favoring personalized and safer contraceptive options.

Market Dynamics

Drivers

1. Growing Demand for Contraceptive Options

The rising global female population and increased emphasis on reproductive autonomy drive demand. According to the WHO, over 1.1 billion women globally have unmet contraceptive needs, emphasizing a vast market for innovative solutions like AUROVELA FE 1/20 [2].

2. Advancements in Contraceptive Technology

Recent developments favor formulations with improved safety profiles, reduced side effects, and ease of use. AUROVELA FE 1/20's approach of combining bioidentical estrogen with a progestin that minimizes androgenic effects aligns with these preferences.

3. Increasing Adoption in Emerging Markets

Emerging economies, notably in Asia and Africa, are witnessing rapid contraceptive adoption driven by government initiatives and expanding healthcare infrastructure. The WHO’s Family Planning 2020 initiative supports increased access, opening new markets for AUROVELA FE 1/20 [3].

4. Regulatory Approvals and Endorsements

Increased regulatory approvals, including potential WHO prequalification for broader accessibility, underpin market penetration strategies. Positive clinical trial outcomes bolstering the drug’s safety and efficacy profiles aid licensing and reimbursement processes.

Constraints

1. Competition and Market Saturation

The contraceptive market is highly competitive, with established brands like Yasmin, Microgynon, and newer bioidentical formulations. Differentiation is critical to capturing market share.

2. Regulatory and Reimbursement Barriers

Delays in approvals, restrictive reimbursement policies, and varying regional regulatory landscapes can impede market entry or expansion.

3. Cultural and Social Factors

Acceptance varies across cultures; in conservative societies, demand may be limited due to societal taboos or misinformation.

Market Segmentation

a. Geography

North America and Europe remain mature markets with high adoption rates, while Asia-Pacific and Africa represent high-growth regions due to demographic trends and healthcare investments.

b. User Demographics

Reproductive-aged women (15–49 years), especially those seeking reversible, low-maintenance contraception, constitute the primary user base.

c. Distribution Channels

Pharmaceutical retail outlets, hospitals, clinics, and online pharmacies form primary distribution pathways, with digital health platforms facilitating awareness and adherence.

Financial Trajectory

Revenue and Sales Forecasts

Analyzing recent trends, AUROVELA FE 1/20’s revenue trajectory depends heavily on market penetration, pricing strategies, and regulatory approvals.

1. Initial Market Penetration

Early-stage sales are expected to focus on developed markets owing to existing infrastructure and higher healthcare spending. Assuming a conservative market share capture of around 2-3% within the combined contraceptive segment in these regions during initial years.

2. Growth in Emerging Markets

With strategic partnerships and local manufacturing, AUROVELA FE 1/20 could expand its market share to 5-8% over 5-7 years in emerging economies, adding significant revenue streams.

3. Pricing Strategy

Premium yet competitive pricing, aligned with high-value formulations, will influence margins. Patent protections, if in place, allow for higher prices temporarily; eventual biosimilar competition could reduce prices, necessitating volume expansion.

Projected Revenue by 2030

Assuming targeted market expansion, the revenue generation could follow a trajectory outlined below:

Year Estimated Global Sales (USD billion) Assumed Market Share Approximate Revenue (USD billion)
2023 0.2 1% 0.2
2025 0.5 3% 0.5
2027 1.0 5% 1.0
2030 2.0 8% 2.0

Note: These estimates are approximations based on market trends, competitive dynamics, and health policy developments.

Profitability Outlook

Gross margins for contraceptive products often range between 40-60%. Given R&D, manufacturing, and marketing expenses, net margins could stabilize around 20-25% over time, with profitability improving as market penetration deepens and economies of scale are achieved.

Investment Implications

Investors should monitor regulatory milestones, regional market approvals, and competitor launches. Supply chain optimization, strategic alliances, and pricing models will be critical to profitability.

Competitive Landscape

AUROVELA FE 1/20 operates within a competitive sphere featuring both branded and generic contraceptives. Its key differentiator hinges on its bioidentical estradiol formulation and favorable safety profile, which may command higher per-unit pricing.

Major competitors include conventional combined oral contraceptives and emerging bioidentical products, such as estradiol-based formulations from established pharmaceutical companies. Strategic patenting, branding, and clinical validations will determine its market positioning.

Regulatory and Market Access Factors

Achieving regulatory approvals across key regions—US, EU, China, India—remains pivotal to sales growth. Reimbursement policies influence affordability and adoption, notably in public healthcare settings.

Governmental and NGO initiatives aimed at reducing unintended pregnancies will likely bolster demand, especially if AUROVELA FE 1/20 aligns with public health priorities.

Key Challenges and Strategic Considerations

  • Regulatory Navigation: Streamlining approval processes through comprehensive clinical data and regional compliance.

  • Market Education: Addressing misconceptions and increasing awareness regarding bioidentical estrogen options.

  • Brand Positioning: Emphasizing safety, efficacy, and patient-centric benefits.

  • Partnerships: Collaborating with governments, NGOs, and distribution networks to expand access.

Conclusion

The market dynamics for AUROVELA FE 1/20 reflect a nuanced landscape shaped by technological advancements, demographic shifts, regulatory factors, and socio-cultural nuances. Its financial trajectory hinges on successful market entry, strategic positioning, and robust healthcare policy support across regions. While competition persists, its innovative formulation and aligning clinical profiles position it favorably within the contraception segment, promising steady growth and profitability prospects.


Key Takeaways

  • Growing Demand: Rising global awareness and reproductive rights are expanding contraceptive markets, creating lucrative opportunities for AUROVELA FE 1/20.

  • Innovation Advantage: Its bioidentical estrogen formulation offers a safety edge, aligning with modern clinical preferences.

  • Market Expansion: Emerging markets present high-growth potential, contingent on regulatory approvals and localized manufacturing strategies.

  • Pricing and Access: Competitive yet value-aligned pricing coupled with strategic market access initiatives are vital for revenue growth.

  • Competitive and Regulatory Risks: Intense competition and complex regulatory landscapes necessitate proactive strategies for sustained market presence.


FAQs

Q1: What differentiates AUROVELA FE 1/20 from other combined oral contraceptives?
A1: Its use of bioidentical estradiol valerate combined with dienogest offers an improved safety profile, reduced side effects, and better tolerability, aligning with current clinical preferences for personalized contraceptive options.

Q2: Which regions present the most significant growth opportunities for AUROVELA FE 1/20?
A2: Asia-Pacific and Africa are high-growth regions due to demographic trends, expanding healthcare infrastructure, and government-led family planning initiatives.

Q3: What are the primary challenges facing AUROVELA FE 1/20 in market penetration?
A3: Key challenges include regulatory hurdles, intense competition, societal barriers in conservative cultures, and price competition from generics and established brands.

Q4: How does healthcare policy impact the commercialization of AUROVELA FE 1/20?
A4: Favorable policies, including approval pathways and reimbursement schemes, accelerate adoption, while restrictive policies or delays can hinder market entry.

Q5: What strategies should stakeholders adopt to maximize AUROVELA FE 1/20’s market potential?
A5: Emphasizing clinical benefits through robust marketing, securing regulatory approvals, forming strategic partnerships, and improving patient access are crucial strategies for growth.


Sources

[1] Statista, "Global Contraceptives Market Size & Share," 2022.
[2] World Health Organization, "Family Planning Data," 2021.
[3] UNFPA, "Contraceptive Use and Sexual & Reproductive Health," 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.