Ethinyl estradiol; levonorgestrel - Generic Drug Details

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-five branded drugs marketed by Agile, Glenmark Pharms Ltd, Avion Pharms, Lupin Ltd, Novast Labs, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Watson Labs, Dr Reddys Labs Sa, Aurobindo Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Hetero Labs, Naari Pte Ltd, and Endo Operations, and is included in seventy-six NDAs. There are eight patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has one hundred and eight patent family members in twenty-eight countries.

Twenty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ethinyl estradiol; levonorgestrel

International Patents:	108
US Patents:	8
Tradenames:	55
Applicants:	24
NDAs:	76
Finished Product Suppliers / Packagers:	27
Clinical Trials:	60
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; levonorgestrel
DailyMed Link:	ethinyl estradiol; levonorgestrel at DailyMed

Recent Clinical Trials for ethinyl estradiol; levonorgestrel

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
FHI 360	N/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A

See all ethinyl estradiol; levonorgestrel clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant	Application No.	Strength	Dosage Form
		0.03MG,0.01MG; 0.15MG,N/A	TABLET;ORAL
		0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,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.

Pharmacology for ethinyl estradiol; levonorgestrel

Drug Class	Estrogen Progestin Progestin-containing Intrauterine System Progestin-containing Intrauterine Device
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; levonorgestrel

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

G03AD	Emergency contraceptives
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 ETHINYL ESTRADIOL; LEVONORGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14
QUARTETTE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg	204061	1	2013-07-10
LOSEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg and 0.01 mg	022262	1	2009-11-16
SEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg/0.01 mg	021840	1	2008-01-22
LYBREL	Tablets	ethinyl estradiol; levonorgestrel	0.09 mg/0.02 mg	021864	1	2007-10-05
SEASONALE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg	021544	1	2004-03-29

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203164-001	Jun 12, 2015	AB	RX	No	No
Hetero Labs	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	212298-001	Feb 13, 2023	AB1	RX	No	No
Novast Labs Ltd	LEVONEST	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	090719-001	Dec 29, 2010	AB	RX	No	No
Dr Reddys Labs Sa	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	076625-001	Nov 18, 2004	AB1	RX	No	Yes

Expired US Patents for ethinyl estradiol; levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	7,615,545
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	7,615,545
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984	3,850,911
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982	3,850,911

International Patents for ethinyl estradiol; levonorgestrel

Country	Patent Number	Title	Estimated Expiration
China	101626760	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
China	1599614
Taiwan	200831107	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
European Patent Office	2167002	DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINT IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Ethinyl estradiol; levonorgestrel Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinyl Estradiol and Levonorgestrel

Introduction

Ethinyl estradiol and levonorgestrel, a combination of hormones used in oral contraceptives, have been a cornerstone in reproductive health for decades. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this market segment.

Market Size and Growth

The market for ethinyl estradiol and levonorgestrel has experienced rapid and substantial growth in recent years. According to market research, this trend is expected to continue from 2023 to 2031, with forecasts indicating significant expansion during this period[1].

• Global Market Size: The global contraceptive drugs market, which includes ethinyl estradiol and levonorgestrel, was valued at USD 16.94 billion in 2023 and is projected to reach USD 30.06 billion by 2033, growing at a CAGR of 5.9% from 2024 to 2033[3].

• Regional Market: North America dominates the contraceptive drugs market, driven by growing awareness and strategies adopted by market players. The U.S. contraceptive drugs market alone was estimated at USD 4.77 billion in 2023 and is predicted to be worth around USD 8.92 billion by 2033, at a CAGR of 6.5%[3].

Market Segmentation

The market for ethinyl estradiol and levonorgestrel is segmented based on several key factors:

• By Application: The market is segmented into hospital and drug store applications. This segmentation helps in understanding the distribution channels and consumer behavior[1].

• By Product: Different dosages such as 0.02mg/0.1mg, 0.03mg/0.15mg, 0.01mg/0.15mg, and 0.02mg/0.09mg are available, catering to various patient needs and preferences[1].

• By Geography: The market is analyzed across regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This geographical segmentation highlights regional market dynamics and growth opportunities[1].

Drivers and Restraints

Several factors drive and restrain the growth of the ethinyl estradiol and levonorgestrel market:

• Drivers: Increasing awareness about contraceptive pills, growing demand for effective birth control methods, and favorable regulations are key drivers. Additionally, investments by organizations like the Bill & Melinda Gates Foundation in developing innovative contraceptive technologies further boost the market[3].

• Restraints: Common side effects such as nausea, acne, and mood changes can deter some users. Moreover, health risks associated with blood clots, coronary artery disease, and hypertension may limit the market growth[4].

Product Variations and Pricing

The market offers various product formulations and regimens:

• Seasonale and Lybrel: These are examples of extended-cycle and continuous-cycle oral contraceptives. Seasonale contains 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel, dispensed in a 91-day cycle, while Lybrel contains 90 mcg of levonorgestrel and 20 mcg of ethinyl estradiol, taken continuously without a break[2][5].

• Pricing: The cost of these contraceptives can vary. For instance, Seasonale costs approximately $120.57 for a 91-day cycle, and Lybrel costs around $54 per month. These prices are comparable to or slightly higher than conventional oral contraceptives[2][5].

Distribution Channels

The distribution of ethinyl estradiol and levonorgestrel products is significant for market growth:

• Retail Pharmacy: This segment accounted for the largest revenue share in 2023, driven by rising demand and increased awareness among the general public[3].

• Online Channels: The online distribution channel is expected to grow at the fastest rate during the forecast period, driven by increased usage of over-the-counter solutions and online discounts[3].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics:

• Simplicity and Convenience: Extended-cycle and continuous-cycle regimens like Seasonale and Lybrel offer the convenience of fewer refills per year, which can be a significant advantage for users[2][5].

• Effectiveness and Side Effects: While these contraceptives are effective in preventing pregnancy, the incidence of unexpected bleeding and other side effects can influence consumer preferences and adherence to the regimen[2][4].

Key Players

Several prominent companies are involved in the production and distribution of ethinyl estradiol and levonorgestrel products:

• Teva, Pfizer, Aurobindo Pharma, Laboratorios Leon Farma, Glenmark, Allergan, Avion Pharmaceuticals, LUPIN, Mayne Pharma, Novast, Mylan, Amneal Pharmaceuticals are some of the key players in this market. These companies contribute to the market's competitive landscape and innovation[1].

Financial Outlook

The financial trajectory of the ethinyl estradiol and levonorgestrel market is promising:

• Revenue Growth: The market is expected to see robust growth rates throughout the forecast period, driven by increasing demand and favorable market dynamics[1].

• Investments and Funding: Investments by organizations and market players in developing new technologies and products will further support the financial growth of this market segment[3].

Challenges and Opportunities

Despite the positive outlook, the market faces several challenges and opportunities:

• Challenges: Managing side effects, addressing health risks, and maintaining regulatory compliance are key challenges. Additionally, competition from other contraceptive methods, such as vaginal rings and subdermal implants, can impact market share[4].

• Opportunities: The growing awareness about contraceptive pills, especially in developing markets, and the introduction of new products offer significant opportunities for growth. The online distribution channel also presents a lucrative opportunity for market expansion[3].

Conclusion

The market for ethinyl estradiol and levonorgestrel is poised for significant growth, driven by increasing demand, favorable regulations, and investments in innovative technologies. Understanding the market dynamics, product variations, distribution channels, and consumer behavior is crucial for stakeholders to capitalize on the opportunities and navigate the challenges in this market.

Key Takeaways

• The global contraceptive drugs market, including ethinyl estradiol and levonorgestrel, is expected to grow significantly from 2023 to 2033.
• North America dominates the market, driven by growing awareness and strategic investments.
• The market is segmented by application, product dosage, and geography.
• Key drivers include increasing awareness and favorable regulations, while restraints include side effects and health risks.
• Retail pharmacy and online channels are significant distribution segments.
• Consumer behavior is influenced by simplicity, effectiveness, and side effects.

FAQs

Q: What are the common dosages of ethinyl estradiol and levonorgestrel? A: Common dosages include 0.02mg/0.1mg, 0.03mg/0.15mg, 0.01mg/0.15mg, and 0.02mg/0.09mg[1].

Q: Which regions are expected to drive the growth of the ethinyl estradiol and levonorgestrel market? A: North America and Asia-Pacific are expected to be key drivers of market growth[1][3].

Q: What are the main side effects of ethinyl estradiol and levonorgestrel? A: Common side effects include nausea, acne, headache, and mood changes. Serious side effects can include blood clots and heart problems[4].

Q: How do extended-cycle and continuous-cycle regimens like Seasonale and Lybrel differ from conventional oral contraceptives? A: These regimens offer the convenience of fewer refills per year and may reduce the frequency of menstrual cycles[2][5].

Q: What is the expected CAGR of the global contraceptive drugs market from 2024 to 2033? A: The global contraceptive drugs market is expected to grow at a CAGR of 5.9% from 2024 to 2033[3].

Citations

1. Market Research Intellect, "Global Ethinyl Estradiol And Levonorgestrel Market Size And Forecast".
2. American Academy of Family Physicians, "Ethinyl Estradiol/Levonorgestrel (Seasonale) for Oral Contraception".
3. Precedence Research, "Contraceptive Drugs Market Size, Report 2024-2033".
4. WebMD, "Levonorgestrel/Ethinyl Estradiol - Uses, Side Effects, and More".
5. American Academy of Family Physicians, "Levonorgestrel/Ethinyl Estradiol (Lybrel) for Continuous Contraception".