DROSPIRENONE; ETHINYL ESTRADIOL - Generic Drug Details

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

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Summary for DROSPIRENONE; ETHINYL ESTRADIOL

US Patents:	2
Tradenames:	16
Applicants:	16
NDAs:	33
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	35
Patent Applications:	1,428
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE; ETHINYL ESTRADIOL
DailyMed Link:	DROSPIRENONE; ETHINYL ESTRADIOL at DailyMed

Recent Clinical Trials for DROSPIRENONE; ETHINYL ESTRADIOL

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Eli Lilly and Company	Phase 1
Bristol-Myers Squibb	Phase 1

See all DROSPIRENONE; ETHINYL ESTRADIOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ETHINYL ESTRADIOL

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YAZ	Tablets	drospirenone; ethinyl estradiol	3 mg/0.02 mg	021676	1	2006-09-29
YASMIN	Tablets	drospirenone; ethinyl estradiol	3 mg/0.03 mg	021098	1	2005-01-07

US Patents and Regulatory Information for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	KEMEYA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202138-001	Mar 13, 2019		DISCN	No	No
Jubilant Cadista	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	209423-001	Dec 22, 2017		DISCN	No	No
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes	8,617,597		Y
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221-001	Mar 28, 2011	AB	RX	No	No
Xiromed	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	202594-001	Oct 22, 2015	AB	RX	No	No
Glenmark Pharms Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	204848-001	Mar 25, 2016	AB	RX	No	No

Expired US Patents for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	7,163,931
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	5,569,652
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE43916
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE38253
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	5,569,652
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	6,933,395

DROSPIRENONE; ETHINYL ESTRADIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Drospirenone and Ethinyl Estradiol

Introduction

Drospirenone and ethinyl estradiol, a combination hormonal contraceptive, has been a significant player in the pharmaceutical market, particularly in the segments of birth control, premenstrual dysphoric disorder (PMDD), and acne treatment. This article delves into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and key factors influencing its market performance.

Market Size and Growth Prospects

The global market for drospirenone and ethinyl estradiol tablets has shown promising growth. As of 2023, the market size was valued at several million USD, and it is forecasted to continue growing in the coming years[1][4].

Competitive Landscape

The competitive landscape of the drospirenone and ethinyl estradiol market is characterized by several key players, each with their own marketing strategies and market contributions. The report provides a detailed analysis of the competitive environment, including the successful strategies of leading companies and their recent developments[1].

Drivers of the Market

Several factors drive the demand for drospirenone and ethinyl estradiol tablets:

Contraceptive Needs

The primary driver is the ongoing need for effective birth control methods. Drospirenone and ethinyl estradiol combination is widely used for its efficacy in preventing pregnancy[5].

Non-Contraceptive Benefits

In addition to contraception, this combination is also indicated for the treatment of PMDD and moderate acne, which expands its market appeal. It is the only hormonally based contraceptive regimen with FDA indications for PMDD and acne[3].

Demographic Factors

The increasing awareness and acceptance of hormonal contraceptives among women, particularly in younger age groups, contribute to the market growth.

Restraints and Challenges

Despite the growth drivers, there are several restraints and challenges that impact the market:

Side Effects and Health Risks

The use of drospirenone and ethinyl estradiol is associated with increased risks of blood clots, heart attacks, and strokes, especially in smokers over 35 years old. These risks can deter some potential users[5].

Regulatory Scrutiny

The pharmaceutical industry is heavily regulated, and any changes in regulatory policies or safety concerns can impact the market negatively.

Alternative Treatments

The availability of alternative birth control methods and treatments for PMDD and acne can also affect the demand for drospirenone and ethinyl estradiol.

Cost-Effectiveness

Studies have shown that the use of drospirenone and ethinyl estradiol can be cost-effective, particularly in reducing healthcare resource utilization for acne treatment. A study found that drug costs, medical costs, and total costs were decreased by 37-38% after the initiation of this contraceptive regimen[2].

Regional Market Analysis

The market for drospirenone and ethinyl estradiol tablets is analyzed on a global and regional basis. Different regions have varying growth prospects based on factors such as population demographics, healthcare infrastructure, and regulatory environments[1][4].

Key Players and Their Strategies

Leading companies in the market have adopted various strategies to maintain and expand their market share. These include innovative marketing campaigns, partnerships, and continuous research and development to improve the product's efficacy and safety profile[1].

Financial Performance

The financial performance of the market is reflected in the revenue generated by the sales of drospirenone and ethinyl estradiol tablets. The market is expected to grow, driven by increasing demand and the expansion of distribution channels. The pricing of the reports on this market, ranging from $3480 to $6960 depending on the license type, indicates the commercial value of the market data and analysis[1].

Consumer Preferences and Awareness

Consumer preferences play a crucial role in the market dynamics. Women's increasing awareness of the benefits and risks associated with hormonal contraceptives influences their choices. The unique benefits of drospirenone and ethinyl estradiol, such as its efficacy in treating PMDD and acne, make it a preferred option for many[3].

Technological and Research Advancements

Continuous research and development are essential for maintaining the market position of drospirenone and ethinyl estradiol. Advances in pharmaceutical technology and clinical trials help in improving the safety and efficacy of the drug, which can further boost its market performance.

Regulatory Environment

The regulatory environment is a critical factor in the pharmaceutical industry. Changes in FDA regulations or safety guidelines can significantly impact the market. For instance, the FDA indications for PMDD and acne treatment have been a significant boost to the market for drospirenone and ethinyl estradiol[3].

Market Opportunities and Threats

Opportunities

• Expanding into new markets, especially in regions with growing populations and increasing healthcare needs.
• Developing new formulations or delivery methods that enhance user compliance and safety.
• Leveraging the non-contraceptive benefits to target a broader patient base.

Threats

• Increasing competition from other birth control methods and treatments for PMDD and acne.
• Regulatory changes or safety concerns that could impact market approval or user confidence.
• Economic factors such as recession or changes in healthcare policies that could affect consumer spending on pharmaceuticals.

Key Takeaways

• The global market for drospirenone and ethinyl estradiol tablets is growing, driven by its efficacy in contraception, PMDD, and acne treatment.
• The market is characterized by a competitive landscape with several key players.
• Cost-effectiveness, particularly in reducing healthcare resource utilization for acne, is a significant advantage.
• Regulatory environment, consumer preferences, and technological advancements are crucial factors influencing the market.
• The market faces challenges such as side effects, regulatory scrutiny, and alternative treatments.

FAQs

1. What are the primary uses of drospirenone and ethinyl estradiol?

   • Drospirenone and ethinyl estradiol are primarily used for birth control, treatment of premenstrual dysphoric disorder (PMDD), and moderate acne in women[3][5].

2. What are the unique benefits of drospirenone and ethinyl estradiol compared to other contraceptives?

   • This combination is the only hormonally based contraceptive with FDA indications for PMDD and acne treatment, in addition to its contraceptive efficacy[3].

3. What are the potential health risks associated with drospirenone and ethinyl estradiol?

   • The use of drospirenone and ethinyl estradiol is associated with increased risks of blood clots, heart attacks, and strokes, especially in smokers over 35 years old[5].

4. How does the use of drospirenone and ethinyl estradiol impact healthcare costs?

   • Studies have shown that the use of this contraceptive regimen can reduce healthcare resource utilization and costs, particularly for acne treatment[2].

5. What are the regulatory considerations for drospirenone and ethinyl estradiol?

   • The drug has received FDA indications for contraception, PMDD, and moderate acne. Regulatory changes or safety concerns can impact its market approval and user confidence[3].

Cited Sources:

1. Absolute Reports - Global Drospirenone and Ethinyl Estradiol Tablets Market 2024 by ...
2. PubMed - Use of drospirenone/ethinyl estradiol (DRSP/EE) among women ...
3. PubMed - Drospirenone/ethinyl estradiol - PubMed
4. Market Research Reports - Global Drospirenone and Ethinyl Estradiol Tablets Market 2024 by ...
5. Mayo Clinic - Drospirenone and ethinyl estradiol (oral route) - Mayo Clinic