ETHINYL ESTRADIOL AND NORELGESTROMIN Drug Patent Profile

When do Ethinyl Estradiol And Norelgestromin patents expire, and when can generic versions of Ethinyl Estradiol And Norelgestromin launch?

Ethinyl Estradiol And Norelgestromin is a drug marketed by Amneal and Zydus Noveltech Inc and is included in two NDAs.

The generic ingredient in ETHINYL ESTRADIOL AND NORELGESTROMIN is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ethinyl Estradiol And Norelgestromin

A generic version of ETHINYL ESTRADIOL AND NORELGESTROMIN was approved as ethinyl estradiol; norelgestromin by AMNEAL on February 25^th, 2021.

Summary for ETHINYL ESTRADIOL AND NORELGESTROMIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	6
Clinical Trials:	20
DailyMed Link:	ETHINYL ESTRADIOL AND NORELGESTROMIN at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL AND NORELGESTROMIN

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

Sponsor	Phase
Mylan Technologies Inc.	Phase 3
Mylan Inc.	Phase 3
Janssen Research & Development, LLC	Phase 4

See all ETHINYL ESTRADIOL AND NORELGESTROMIN clinical trials

Pharmacology for ETHINYL ESTRADIOL AND NORELGESTROMIN

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ETHINYL ESTRADIOL AND NORELGESTROMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	213950-001	Feb 25, 2021	AB	RX	No	No
Zydus Noveltech Inc	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	214594-001	Sep 14, 2023	AB	RX	No	No

EU/EMA Drug Approvals for ETHINYL ESTRADIOL AND NORELGESTROMIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gedeon Richter Plc.	Evra	norelgestromin, ethinyl estradiol	EMEA/H/C/000410 Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.	Authorised	no	no	no	2002-08-22

ETHINYL ESTRADIOL AND NORELGESTROMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinyl Estradiol and Norelgestromin

Introduction

Ethinyl estradiol and norelgestromin, combined in the transdermal contraceptive patch known as Ortho Evra or Evra, have been a significant player in the contraceptive market since their introduction. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Demand and User Preferences

The Ortho Evra patch has been appreciated for its convenience, being applied once a week for three weeks, followed by a patch-free week. This ease of use has attracted many women seeking a hassle-free contraceptive method[5].

Competitive Landscape

The contraceptive market is highly competitive, with various forms of birth control available, including oral contraceptives, intrauterine devices (IUDs), and other transdermal patches. However, Ortho Evra has carved out a niche due to its unique delivery system and user-friendly application[5].

Regulatory Environment

The FDA has played a crucial role in shaping the market dynamics of Ortho Evra. In 2005, the FDA issued a warning regarding the higher systemic exposure to ethinyl estradiol from the patch compared to typical oral contraceptives, which led to increased scrutiny and potential impact on sales[4].

Pharmacokinetics and Safety Concerns

The pharmacokinetic profile of Ortho Evra, which includes higher steady-state concentrations and lower peak concentrations of ethinyl estradiol compared to oral contraceptives, has been a subject of discussion. This higher exposure has raised concerns about adverse effects such as venous thromboembolism (VTE), nausea, and breast tenderness[1][4].

Financial Performance

The financial trajectory of Ortho Evra has been influenced by several factors, including market demand, regulatory actions, and safety concerns.

Initial Success

Upon its introduction, Ortho Evra saw significant market uptake due to its innovative delivery system and convenience. This led to substantial revenue generation for the manufacturer.

Impact of FDA Warnings

Following the FDA warnings about increased estrogen exposure and potential health risks, the sales of Ortho Evra experienced a decline. This was partly due to increased caution among healthcare providers and consumers, as well as the introduction of alternative contraceptive methods[4].

Market Adaptation

Despite these challenges, the product has maintained a presence in the market. Manufacturers have continued to promote the patch's benefits, such as its ease of use and the avoidance of gastrointestinal and hepatic first-pass metabolism. However, the product's effectiveness for women weighing over 90 kg has been a limiting factor, affecting its broader market appeal[4].

Pricing and Accessibility

The pricing of Ortho Evra has been a critical factor in its market dynamics. The cost of the patch, which requires a prescription, can be a barrier for some users. However, many health insurance plans cover the cost of contraceptive patches, making them more accessible to a wider audience[5].

Global Market Presence

Ortho Evra is available in various countries, including the United States and Canada, although the formulations may differ slightly. In Canada, for example, the patch contains 0.60 mg of ethinyl estradiol, compared to 0.75 mg in the U.S. version. This variation can impact the product's performance and market reception in different regions[4].

Future Outlook

The future financial trajectory of ethinyl estradiol and norelgestromin patches will depend on several factors:

Innovation and Competition

The introduction of new contraceptive methods and technologies could impact the market share of Ortho Evra. However, its established brand and user base provide a solid foundation for continued sales.

Regulatory Updates

Any updates or changes in regulatory guidelines could influence the product's market dynamics. For instance, clearer guidelines on the safety profile and efficacy could help in regaining consumer trust.

Marketing Strategies

Effective marketing strategies that highlight the convenience, safety, and efficacy of the patch will be crucial in maintaining and potentially increasing market share.

Key Takeaways

• Convenience and User Preferences: The once-a-week application of Ortho Evra has been a significant selling point.
• Regulatory Environment: FDA warnings have impacted sales, but the product remains on the market.
• Pharmacokinetics and Safety: Higher systemic exposure to ethinyl estradiol has raised safety concerns.
• Financial Performance: Initial success followed by a decline due to safety concerns, but the product maintains market presence.
• Pricing and Accessibility: Cost and insurance coverage are critical factors in accessibility.
• Global Market Presence: Variations in formulation between regions can affect market performance.

FAQs

1. What is the primary benefit of using the Ortho Evra patch?

   • The primary benefit is its convenience, requiring application only once a week for three weeks, followed by a patch-free week[5].

2. How does the pharmacokinetic profile of Ortho Evra differ from oral contraceptives?

   • Ortho Evra has higher steady-state concentrations and lower peak concentrations of ethinyl estradiol compared to oral contraceptives[1][4].

3. What are the potential health risks associated with Ortho Evra?

   • Potential health risks include venous thromboembolism (VTE), nausea, and breast tenderness due to higher systemic exposure to ethinyl estradiol[1][4].

4. Is Ortho Evra effective for all women?

   • The patch may be less effective for women weighing more than 90 kg[4].

5. How has the FDA impacted the market dynamics of Ortho Evra?

   • The FDA warnings about increased estrogen exposure have led to increased scrutiny and potential decline in sales[4].

Cited Sources

1. Ortho Evra (norelgestromin and ethinyl estradiol) - accessdata.fda.gov
2. Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra/Evra) under conditions of heat, humidity, and exercise. - PubMed
3. Pharmacokinetics of Norelgestromin and Ethinyl Estradiol From Two Consecutive Applications of a Contraceptive Patch (ORTHO EVRA/EVRA). - PubMed
4. The Evra (ethinyl estradiol/norelgestromin) contraceptive patch - CMAJ
5. Ethinyl estradiol and norelgestromin (transdermal route) - Mayo Clinic