Ethinyl estradiol; norethindrone - Generic Drug Details

What are the generic sources for ethinyl estradiol; norethindrone and what is the scope of patent protection?

Ethinyl estradiol; norethindrone is the generic ingredient in one hundred and eighteen branded drugs marketed by Lupin Ltd, Teva Branded Pharm, Xiromed, Apil, Aurobindo Pharma, Amneal Pharms, Barr, Naari Pte Ltd, Allergan, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Endo Operations, Novast Labs Ltd, Mylan Labs Ltd, Warner Chilcott Llc, Wilshire Pharms Inc, Millicent Pr, Teva Pharms Usa Inc, Novast Labs, Lupin, Barr Labs Inc, Apotex, Glenmark Speclt, and Parke Davis, and is included in one hundred and fifty NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for ethinyl estradiol; norethindrone

US Patents:	1
Tradenames:	118
Applicants:	32
NDAs:	150
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	41
Patent Applications:	359
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; norethindrone
DailyMed Link:	ethinyl estradiol; norethindrone at DailyMed

Recent Clinical Trials for ethinyl estradiol; norethindrone

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

Sponsor	Phase
University of Virginia	Early Phase 1
Celerion	Phase 1
Achillion, a wholly owned subsidiary of Alexion	Phase 1

See all ethinyl estradiol; norethindrone clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE

Applicant	Application No.	Strength	Dosage Form
		0.01MG,0.01MG;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.

Pharmacology for ethinyl estradiol; norethindrone

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

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

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

US Patents and Regulatory Information for ethinyl estradiol; norethindrone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	GILDESS 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	077075-002	Jul 24, 2012		DISCN	No	No
Lpi	N.E.E. 1/35 21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	071541-001	Dec 14, 1987		DISCN	No	No
Xiromed	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	202770-001	Feb 19, 2015	AB	RX	No	No
Novast Labs	LERIBANE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203435-001	Jun 3, 2016	AB	RX	No	No
Aurobindo Pharma	AUROVELA 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	207504-001	Jun 15, 2017	AB	RX	No	No
Ortho Mcneil Janssen	ORTHO-NOVUM 10/11-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018354-002	Jan 11, 1982		DISCN	Yes	No
Barr	NORTREL 0.5/35-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	072695-001	Feb 28, 1992	AB	RX	No	No

Expired US Patents for ethinyl estradiol; norethindrone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,544,554
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,544,554
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,530,839
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	5,552,394
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,628,051
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	4,616,006
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	4,616,006

Ethinyl estradiol; norethindrone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinyl Estradiol; Norethindrone

Introduction

Ethinyl estradiol and norethindrone acetate are widely used in combination products for routine contraception and hormone replacement therapy (HRT). Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for combined hormonal contraceptives (CHCs) and HRT products is significant, with a broad user base spanning from menarche to menopause. Ethinyl estradiol and norethindrone acetate are key components of these products, which are available under various brand names such as Femcon Fe, Generess Fe, and Ovcon 35[5].

Demand and User Base

The demand for CHCs and HRT products is driven by the need for effective contraception and hormonal balance. These products are used by a diverse group of women, including those seeking to prevent pregnancy and those requiring hormonal therapy for menopausal symptoms or other conditions. The user base is extensive, with these products being prescribed from the time of menarche until menopause, provided there are no contraindications[4].

Competitive Landscape

The market for CHCs and HRT is competitive, with multiple brands and generic versions available. The entry of generic drugs significantly impacts the market dynamics, as generic prices tend to be lower than those of branded products. Studies have shown that generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are eight or more competitors[3].

Pricing and Revenue

The pricing of ethinyl estradiol and norethindrone acetate products is influenced by the number of competitors in the market. Branded products typically command higher prices due to their brand reputation and marketing efforts. However, the introduction of generic versions can lead to a reduction in prices, making these products more accessible to a wider audience.

Generic Competition

Generic versions of these drugs enter the market once the patent of the branded product expires. This competition leads to a decrease in prices, as seen in other generic drug markets where prices drop by 35-50% initially and continue to decline as more competitors enter[3].

Revenue Impact

The revenue generated from these products can be substantial, but it is affected by the level of competition. Branded products generally generate higher revenues due to their premium pricing. However, as generic versions become available, the revenue share of branded products may decline. The overall market size and expected rents play a significant role in determining the number of firms that enter the market and the subsequent revenue distribution[3].

Clinical Efficacy and Safety

The clinical efficacy and safety profile of ethinyl estradiol and norethindrone acetate are well-documented. Studies have shown that these products are effective in preventing pregnancy, with a safety and tolerability profile comparable to other low-dose CHCs[2].

Adverse Reactions

Common adverse reactions include breast tenderness, vaginal candidiasis, and changes in blood pressure. These side effects can impact user compliance and, consequently, the market demand. However, the overall safety profile supports their continued use in a wide range of patients[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of these drugs. Changes in FDA policies, such as increased scrutiny of generic drug applications or simultaneous approval of multiple generic entrants, can affect the entry of new competitors and the pricing of these products. For instance, the FDA's policy of approving several generic entrants simultaneously can lead to earlier competition and lower prices but may also reduce expected rents, potentially deterring some firms from entering the market[3].

Financial Trajectory

The financial trajectory of ethinyl estradiol and norethindrone acetate products is influenced by several factors, including market competition, regulatory changes, and user demand.

Revenue Growth

The revenue from these products can grow steadily due to their widespread use and the continuous need for contraception and HRT. However, the growth may be tempered by the entry of generic competitors, which can erode the market share of branded products.

Profit Margins

Profit margins for these products are affected by the level of competition and the pricing strategy. Branded products typically have higher profit margins due to their premium pricing, but these margins can be reduced as generic competition increases. The generic drug industry dynamics suggest that prices and profit margins decline as the number of competitors increases, eventually approaching long-run marginal costs[3].

Market Trends

Several trends are shaping the market for ethinyl estradiol and norethindrone acetate:

Increasing Generic Competition

The increasing number of generic entrants is a significant trend, leading to lower prices and increased accessibility of these products.

Regulatory Changes

Changes in regulatory policies, such as the FDA's approach to approving generic drugs, can impact the market dynamics and financial trajectory of these products.

Patient Preferences

Patient preferences for low-dose hormonal contraceptives and HRT products continue to drive the demand for ethinyl estradiol and norethindrone acetate. Ultra-low dose regimens, for example, have been shown to be effective and well-tolerated, contributing to their popularity[2].

Key Takeaways

• Market Demand: The demand for ethinyl estradiol and norethindrone acetate is driven by the need for effective contraception and HRT.
• Competitive Landscape: The market is competitive, with both branded and generic products available.
• Pricing and Revenue: Prices are influenced by competition, with generic versions leading to lower prices.
• Regulatory Environment: FDA policies significantly impact the market dynamics.
• Financial Trajectory: Revenue growth is steady but can be affected by generic competition and regulatory changes.

FAQs

Q: What are the common uses of ethinyl estradiol and norethindrone acetate?

A: These hormones are commonly used in combination products for routine contraception and hormone replacement therapy (HRT)[4].

Q: How does generic competition affect the pricing of these products?

A: Generic competition leads to lower prices, with prices dropping by 35-50% initially and continuing to decline as more competitors enter the market[3].

Q: What are the common adverse reactions associated with ethinyl estradiol and norethindrone acetate?

A: Common adverse reactions include breast tenderness, vaginal candidiasis, and changes in blood pressure[4].

Q: How do regulatory changes impact the market for these products?

A: Regulatory changes, such as the FDA's policy of approving multiple generic entrants simultaneously, can lead to earlier competition and lower prices but may also reduce expected rents[3].

Q: What is the financial impact of generic competition on branded products?

A: Generic competition can erode the market share of branded products, reducing their revenue and profit margins as prices approach long-run marginal costs[3].

Sources

1. Formation of Ethinyl Estradiol in Women during Treatment with Norethindrone Acetate - Journal of Clinical Endocrinology and Metabolism[1].
2. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms - PubMed[2].
3. Generic Drug Industry Dynamics - Federal Trade Commission[3].
4. Ethinyl Estradiol; Norethindrone Acetate - Elsevier Healthcare Hub[4].
5. Norethindrone; Ethinyl Estradiol; Ferrous Fumarate Chewable Tablets - Cleveland Clinic[5].