Dienogest; estradiol valerate - Generic Drug Details

What are the generic drug sources for dienogest; estradiol valerate and what is the scope of freedom to operate?

Dienogest; estradiol valerate is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dienogest; estradiol valerate has ninety patent family members in thirty-nine countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dienogest; estradiol valerate

International Patents:	90
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dienogest; estradiol valerate
DailyMed Link:	dienogest; estradiol valerate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dienogest; estradiol valerate

Constraining patent/regulatory exclusivity:

8,071,577

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for dienogest; estradiol valerate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chulalongkorn University	NA
Laboratorios Andromaco S.A.	Phase 1
Suleymaniye Birth And Women's Health Education And Research Hospital	Phase 4

See all dienogest; estradiol valerate clinical trials

Generic filers with tentative approvals for DIENOGEST; ESTRADIOL VALERATE

Applicant	Application No.	Strength	Dosage Form
		N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for dienogest; estradiol valerate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DB	Pregnadien derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for DIENOGEST; ESTRADIOL VALERATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NATAZIA	Tablets	dienogest; estradiol valerate	3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg	022252	1	2010-10-22

US Patents and Regulatory Information for dienogest; estradiol valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes	8,153,616
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes	8,071,577		Y

Expired US Patents for dienogest; estradiol valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	6,133,251
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	6,884,793

International Patents for dienogest; estradiol valerate

Country	Patent Number	Title	Estimated Expiration
Canada	2623024
Austria	E424828
Cyprus	1111292

Supplementary Protection Certificates for dienogest; estradiol valerate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
0770388	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103

Market Dynamics and Financial Trajectory for Dienogest and Estradiol Valerate

Last updated: July 27, 2025

Introduction

Dienogest combined with estradiol valerate constitutes a prominent hormonal therapy primarily used in contraceptive pills and hormone replacement treatments. As a combined oral contraceptive (COC), this pharmaceutical duo offers a distinct clinical profile that influences its market positioning and financial outlook. Analyzing the evolving market dynamics and financial trajectory requires a detailed understanding of the drugs' regulatory approvals, competitive landscape, clinical applications, and emerging trends.

Pharmacological Profile and Clinical Applications

Dienogest is a fourth-generation progestin with strong anti-androgenic properties, primarily employed in managing endometriosis and as an effective component of hormonal contraceptives. Estradiol valerate acts as an estrogenic agent, providing hormonal balance and mitigating side effects associated with estrogen deficiencies.

When combined, these agents are formulated into oral contraceptives that optimize efficacy, reduce menstrual irregularities, and minimize side effects compared to earlier formulations. Their dual mechanism supports not only contraception but also indications like symptomatic endometriosis management, broadening market applications.

Market Dynamics

Regulatory Landscape

In recent years, regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national agencies have approved various formulations containing dienogest and estradiol valerate. Notably, Natazia (or Qlaira), a well-established COC containing dienogest and estradiol valerate, received approval in multiple jurisdictions, underpinning market acceptance.

Regulatory approvals have often focused on efficacy and safety profiles, with accelerated approval pathways available for formulations demonstrating significant clinical advantages. The approval and patent status influence market exclusivity and, subsequently, revenue potential.

Market Penetration and Competition

The global combined oral contraceptive market is highly competitive, with key players including Bayer, Teva, and Mankind Pharma. Dienogest-based formulations face competition from other progestins such as levonorgestrel, desogestrel, and drospirenone.

Despite stiff competition, formulations with dienogest and estradiol valerate differentiate themselves through superior estrogenic and progestogenic balance, favorable side-effect profiles, and expanded indications. These factors facilitate market penetration, particularly in markets with strict regulatory frameworks or demand for high-efficacy contraceptives.

Clinical and Demographic Trends

Globally, there is an increasing demand for reliable, safe, and well-tolerated contraceptives, especially among women aged 18–35. The rising prevalence of endometriosis and hormonal imbalance conditions also fuels demand.

Furthermore, demographic shifts and the empowerment of women's health choices contribute to expanding markets in emerging economies such as India, Brazil, and Southeast Asia. The increasing awareness and healthcare infrastructure investments foster access and usage.

Patent Expiry and Generic Competition

Patent protections for first-generation formulations are gradually expiring, opening pathways for generic versions. This transition often results in significant price reductions, impacting revenue for branded formulations but expanding accessibility.

Generic competition, however, can erode margins initially but also broadens market reach. Companies focusing on proprietary innovations or combination therapies with superior safety profiles can mitigate pricing pressures.

Financial Trajectory

Revenue Projections

Market analysts project a steady compound annual growth rate (CAGR) of approximately 4–6% for the global combined hormonal contraceptive market over the next five years. The segment featuring dienogest and estradiol valerate is expected to outperform the broader market due to its distinctive clinical advantages.

Key revenue drivers include increased adoption in emerging markets, expanded clinical indications, and demographic expansion. Premium-priced formulations with enhanced safety profiles tend to sustain higher margins, especially in developed markets.

Cost Structure and Pricing Trends

Manufacturing costs for combined hormonal drugs are decreasing due to advances in synthesis and supply chain efficiencies. Regulatory compliance costs remain significant but are balanced by economies of scale.

Pricing strategies are shifting towards value-based models, emphasizing clinical benefits, safety, and patient adherence benefits. As patent protections wane, generic price erosion may challenge revenues but benefit patient access and volume sales.

Investment Outlook

Pharmaceutical companies investing in research to optimize formulations, extend patent life, or develop novel combinations involving dienogest and estradiol valerate are poised for long-term growth. Strategic alliances with local distributors can accelerate penetration in lucrative emerging markets.

In addition, increasing clinical evidence supporting new indications, such as treatment for heavy menstrual bleeding or hormone-responsive cancers, could unlock additional revenue streams.

Risks and Challenges

Market entry barriers, regulatory hurdles, and patent litigation pose risks. Additionally, side-effect profiles, such as breakthrough bleeding or spotting, underscore the importance of continued clinical innovation and post-market surveillance.

The potential advent of new contraceptive technologies, non-hormonal options, or digital health integration presents competitive threats.

Emerging Trends Shaping the Market

• Personalized Medicine: Genetic profiling and hormonal sensitivity testing enable tailored therapies, increasing demand for specific formulations like dienogest/estradiol valerate.

• Sustainability and Supply Chain Optimization: Eco-friendly manufacturing practices and efficient supply logistics reduce costs and improve brand reputation.

• Digital Health Integration: Mobile app monitoring of adherence, side effects, and hormonal cycles enhances patient engagement and outcomes, influencing market dynamics.

Regulatory and Policy Factors

Contraceptive legislations, health insurance coverage, and public health policies significantly impact sales. Countries implementing supportive policies for family planning and reproductive health typically exhibit accelerated market growth.

Policy shifts favoring long-acting reversible contraceptives (LARCs) could influence demand for oral formulations unless innovations improve compliance and convenience.

Conclusion

The market for dienogest and estradiol valerate-based therapies is robust and poised for continued growth, driven by demographic trends, expanding indications, and technological innovation. While competitive pressures and patent expiries impact near-term revenues, strategic adaptation—via innovation, geographic expansion, and regulatory navigation—can sustain profitability.

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Key Takeaways

• The combination of dienogest and estradiol valerate enjoys regulatory approval and clinical acceptance in contraceptive and hormone therapy markets, supporting stable revenue streams.
• Market growth is characterized by demographic shifts, rising demand in emerging economies, and expanding indications beyond contraception.
• Patent expirations and generic entries necessitate innovation and strategic positioning to maintain margins.
• Emerging trends such as personalized medicine and digital health integration enhance market potential.
• Companies should monitor policy developments and competition to adapt pricing strategies and optimize market penetration.

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FAQs

1. What distinguishes dienogest/estradiol valerate formulations from other contraceptives?
They offer a favorable safety profile, reduced androgenic side effects, and additional benefits such as management of endometriosis, differentiating them from other progestin-based contraceptives.

2. How do patent expiries affect the market for these drugs?
Patent expiration facilitates generic competition, leading to price reductions but also expanding access, thereby influencing revenue dynamics and market share.

3. What emerging markets are expected to drive future growth?
Developing economies like India, Brazil, and Southeast Asian countries are anticipated to be significant growth drivers due to increasing awareness, healthcare infrastructure, and demographic trends.

4. Are there any notable clinical developments impacting this market?
Yes. Recent research exploring additional indications like heavy menstrual bleeding and hormone-responsive cancers may broaden usage and revenues.

5. What are the main risks for investors in this pharmaceutical segment?
Regulatory delays, patent disputes, market saturation, and technological obsolescence pose significant risks. Staying ahead in clinical innovation and regulatory compliance mitigates these concerns.

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Sources:

[1] Global Hormonal Contraceptive Market Report, 2022.
[2] FDA Approval Databases.
[3] MarketWatch: Contraceptive Pill Market Trends.
[4] Clinical Trials.gov: Studies involving Dienogest and Estradiol Valerate.
[5] Industry Analysts Reports on Fertility and Reproductive Health Trends.