Ethinyl estradiol; norelgestromin - Generic Drug Details

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

Ethinyl estradiol; norelgestromin is the generic ingredient in four branded drugs marketed by Amneal, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, and Mylan Technologies, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for ethinyl estradiol; norelgestromin

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	8
Clinical Trials:	20
DailyMed Link:	ethinyl estradiol; norelgestromin at DailyMed

Recent Clinical Trials for ethinyl estradiol; 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; norelgestromin clinical trials

Pharmacology for ethinyl estradiol; norelgestromin

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

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

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; NORELGESTROMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORTHO EVRA	Transdermal System	ethinyl estradiol; norelgestromin	0.15 mg/0.02 mg per 24 hours	021180	1	2007-03-22

US Patents and Regulatory Information for ethinyl estradiol; norelgestromin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001		DISCN	Yes	No
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910-001	Apr 16, 2014	AB	RX	No	Yes
Amneal	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	213950-001	Feb 25, 2021	AB	RX	No	No

Expired US Patents for ethinyl estradiol; norelgestromin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001

EU/EMA Drug Approvals for ethinyl estradiol; 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; norelgestromin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinyl Estradiol and Norelgestromin (Ortho Evra)

Introduction

The combination of ethinyl estradiol and norelgestromin, marketed under the brand name Ortho Evra (and also known as Evra or Xulane in different regions), is a transdermal contraceptive patch designed to prevent pregnancy. This article delves into the market dynamics and financial trajectory of this drug, highlighting its unique characteristics, market performance, and the factors influencing its financial outlook.

Market Overview

The contraceptive market is highly competitive, with various forms of birth control available, including oral contraceptives, intrauterine devices (IUDs), and barrier methods. The transdermal patch, however, offers a unique convenience factor, appealing to women who prefer a once-a-week application over daily pills or other more invasive methods[5].

Pharmacokinetics and Clinical Profile

The Ortho Evra patch delivers 20 µg of ethinyl estradiol and 150 µg of norelgestromin daily. It avoids first-pass metabolism through the gastrointestinal tract and liver, resulting in higher steady-state concentrations of ethinyl estradiol compared to oral contraceptives. This pharmacokinetic profile is a key differentiator but also raises concerns about increased estrogen exposure and associated risks such as venous thromboembolism (VTE)[2][4].

Market Acceptance and User Base

Despite the convenience and ease of use, the patch has seen varying levels of acceptance. It is particularly popular among women who find it difficult to adhere to a daily oral contraceptive regimen. However, its use is less effective for women weighing over 90 kg, and it may cause more side effects such as dysmenorrhea and breast discomfort compared to oral contraceptives[4].

Regulatory Environment

The FDA has issued warnings regarding the increased risk of VTE associated with the use of Ortho Evra compared to oral contraceptives. This has led to increased scrutiny and ongoing monitoring of the patch's safety profile. Regulatory bodies in different countries have also conducted reviews, with Health Canada promising a more thorough review of the Canadian version of the patch[2][4].

Financial Performance

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

Sales and Revenue

Initially, the patch saw significant sales due to its innovative delivery method and convenience. However, following the FDA warnings and increased awareness of potential risks, sales have been impacted. The company has had to invest in additional safety studies and marketing campaigns to address these concerns.

Cost and Pricing

The cost of Ortho Evra is generally comparable to other contraceptive methods, but the convenience factor can justify a premium price for some users. However, the increased cost of safety monitoring and regulatory compliance has put pressure on the pricing strategy.

Market Share

Ortho Evra holds a significant share in the transdermal contraceptive market but faces competition from other forms of birth control. The market share has been stable but not growing significantly due to the aforementioned concerns.

Competitive Landscape

The contraceptive market is highly competitive, with various products offering different benefits and drawbacks. Oral contraceptives, IUDs, and other forms of birth control compete directly with Ortho Evra. The competitive landscape is further complicated by generic versions of oral contraceptives and the introduction of new contraceptive methods.

Safety Concerns and Litigation

The increased risk of VTE and other adverse effects has led to numerous lawsuits against the manufacturer. These legal challenges have had a significant impact on the financial performance of the drug, as the company has had to allocate substantial resources to defend against these claims and settle lawsuits.

Future Outlook

The future financial trajectory of Ortho Evra will depend on several factors:

Regulatory Compliance

Continued compliance with regulatory requirements and addressing safety concerns will be crucial.

Market Education

Educating healthcare providers and users about the benefits and risks of the patch can help stabilize or grow market share.

Innovation

Any innovations or improvements in the patch's design or delivery system could enhance its appeal and safety profile.

Competitive Strategies

Effective competitive strategies, including pricing and marketing, will be essential to maintain or increase market share.

Key Takeaways

• Convenience Factor: Ortho Evra's once-a-week application is a significant selling point.
• Pharmacokinetics: Higher steady-state concentrations of ethinyl estradiol compared to oral contraceptives.
• Safety Concerns: Increased risk of VTE and other adverse effects.
• Regulatory Scrutiny: Ongoing monitoring by regulatory bodies.
• Financial Impact: Sales and revenue affected by safety concerns and regulatory issues.
• Competitive Landscape: Highly competitive market with various forms of birth control.

FAQs

Q: What is the primary mechanism of action of Ortho Evra?

A: Ortho Evra works by suppressing gonadotropins, inhibiting ovulation, and altering cervical mucus and the endometrium to prevent pregnancy[2].

Q: Why does Ortho Evra have higher estrogen levels compared to oral contraceptives?

A: The transdermal delivery system avoids first-pass metabolism, resulting in higher steady-state concentrations of ethinyl estradiol[2][4].

Q: What are the common side effects of using Ortho Evra?

A: Common side effects include dysmenorrhea, breast discomfort, and an increased risk of VTE[4].

Q: Is Ortho Evra effective for all women?

A: The patch may be less effective for women weighing over 90 kg[4].

Q: How has the FDA warning impacted the sales of Ortho Evra?

A: The FDA warning has led to increased scrutiny and a potential decline in sales due to safety concerns[2][4].

Cited Sources

1. ORTHO EVRA® (norelgestromin / ethinyl estradiol TRANSDERMAL SYSTEM) Label - FDA.
2. Ortho Evra (norelgestromin and ethinyl estradiol) - accessdata.fda.gov - FDA.
3. Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra/Evra) under conditions of heat, humidity, and exercise - PubMed.
4. The Evra (ethinyl estradiol/norelgestromin) contraceptive patch - CMAJ.
5. Ethinyl estradiol and norelgestromin (transdermal route) - Mayo Clinic.