NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Drug Patent Profile

When do Norethindrone And Ethinyl Estradiol And Ferrous Fumarate patents expire, and what generic alternatives are available?

Norethindrone And Ethinyl Estradiol And Ferrous Fumarate is a drug marketed by Teva Branded Pharm, Xiromed, Amneal Pharms, Barr, Lupin Ltd, and Naari Pte Ltd. and is included in seven NDAs.

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

Summary for NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

US Patents:	0
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	5
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
What excipients (inactive ingredients) are in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE?	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE excipients list
DailyMed Link:	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE at DailyMed

Recent Clinical Trials for NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 1

See all NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE clinical trials

US Patents and Regulatory Information for NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	AB	RX	Yes	Yes
Xiromed	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET;ORAL	202086-001	Apr 1, 2015	AB	RX	No	Yes
Barr	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET;ORAL	078965-001	Aug 5, 2010	AB	RX	No	No

Expired US Patents for NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate

Introduction

Norethindrone, ethinyl estradiol, and ferrous fumarate is a combination oral contraceptive that has been a significant player in the women's health market. This article delves into the market dynamics and financial trajectory of this drug, highlighting its key aspects, market performance, and future outlook.

Market Overview

The global pharmaceutical market, valued at over $900 billion, is a substantial backdrop for the norethindrone, ethinyl estradiol, and ferrous fumarate market. This combination drug is part of the broader oral contraceptive market, which is driven by the increasing demand for effective and safe birth control methods[3].

Product Description

This oral contraceptive combines two hormones, norethindrone and ethinyl estradiol, with ferrous fumarate, an iron supplement. The drug works by preventing the full development of a woman's egg, thereby preventing fertilization and pregnancy. The inclusion of ferrous fumarate helps in maintaining iron levels, particularly beneficial during menstruation[5].

Market Segmentation

The target market for norethindrone, ethinyl estradiol, and ferrous fumarate is primarily young women, especially those in the 18 to 24 age group. This demographic is often the focus of marketing efforts due to their higher likelihood of seeking birth control solutions[4].

Financial Performance

Quarterly and Annual Revenue

One of the notable products in this category, LO LOESTRIN FE, has shown significant revenue growth. In the fourth quarter of 2019, LO LOESTRIN FE generated $156.2 million in net revenues, representing an 8.6% increase compared to the same quarter in the previous year. For the full year 2019, it continued to be a major revenue driver for Allergan's women's health business[4].

Sales Trends

The shift in promotional focus from LOESTRIN 24 FE to LO LOESTRIN FE in early 2011 significantly impacted sales. LO LOESTRIN FE saw substantial growth, generating $33 million in net sales in the quarter ended September 30, 2012, and has since remained the primary focus of Allergan's women's healthcare sales efforts[4].

Competitive Advantage

LO LOESTRIN FE, a brand within this category, boasts the lowest dose of estrogen among oral contraceptives. This unique selling point has contributed to its market success and appeal to health-conscious consumers. Effective marketing strategies and affordability options through insurance and savings cards have further enhanced its market position[4].

Clinical and Safety Profile

The combination of norethindrone, ethinyl estradiol, and ferrous fumarate has demonstrated safety and efficacy in clinical trials. The FDA approval and standard post-marketing surveillance ensure that the drug meets stringent safety standards. This profile is crucial in maintaining consumer trust and driving market growth[4].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of this drug. FDA approval is essential, and ongoing post-marketing surveillance ensures that any adverse effects are promptly addressed. Compliance with regulatory requirements is a key factor in the drug's continued market presence[5].

Marketing Impact

Effective marketing campaigns have significantly increased brand awareness and engagement for products like LO LOESTRIN FE. Quotes from industry experts, such as Cindy Schwartz, Associate VP of Marketing at Allergan Women’s Healthcare, emphasize the importance of consumer awareness about the ingredients and effects of their birth control pills. This awareness drives informed decision-making and loyalty to specific brands[4].

Global Market Outlook

The global ferrous fumarate market, which is closely linked to the pharmaceutical industry, is expected to grow due to its applications as an iron supplement. Regions like North America, particularly the U.S., and Asia Pacific, especially India and China, are anticipated to be key drivers of this growth. The well-established pharmaceutical sectors in these regions support the demand for ferrous fumarate, indirectly benefiting the market for norethindrone, ethinyl estradiol, and ferrous fumarate[3].

Future Outlook

Given its strong financial performance, unique selling points, and effective marketing strategies, products like LO LOESTRIN FE are poised to continue as significant players in the oral contraceptive market. Efforts to make these products more affordable and accessible through savings programs will likely sustain their growth trajectory. The ongoing expansion of the pharmaceutical industry, particularly in regions like Asia Pacific, further supports the positive outlook for this market[4].

Key Takeaways

• Target Market: Primarily young millennial women aged 18 to 24.
• Competitive Advantage: Lowest dose of estrogen among oral contraceptives.
• Financial Performance: Significant revenue growth, with notable quarterly and annual revenues.
• Pricing and Affordability: Affordable options available through insurance and savings cards.
• Clinical and Safety Profile: Demonstrated safety and efficacy in clinical trials.
• Regulatory and Postmarket Surveillance: Approved by FDA with standard post-marketing surveillance.
• Marketing Impact: Effective campaigns have increased brand awareness and engagement.

FAQs

What is the primary function of norethindrone, ethinyl estradiol, and ferrous fumarate?

This combination drug is used to prevent pregnancy by stopping a woman's egg from fully developing each month and includes an iron supplement to maintain iron levels.

Which demographic is the primary target market for this drug?

The primary target market is young women, especially those in the 18 to 24 age group.

What is the competitive advantage of LO LOESTRIN FE?

LO LOESTRIN FE has the lowest dose of estrogen among oral contraceptives, making it a unique and appealing option for health-conscious consumers.

How has the financial performance of LO LOESTRIN FE been in recent years?

LO LOESTRIN FE has shown significant revenue growth, with $156.2 million in net revenues in the fourth quarter of 2019 and $114 million in the first quarter of 2018.

Does this drug protect against HIV infection or other sexually transmitted diseases?

No, this medicine does not protect against HIV infection or other sexually transmitted diseases.

Sources

1. FDA Clinical Pharmacology and Biopharmaceutics Review: Norethindrone and Ethinyl Estradiol chewable tablets and ferrous fumarate chewable tablets.
2. DailyMed: Norethindrone and Ethinyl Estradiol and Ferrous Fumarate.
3. Transparency Market Research: Ferrous Fumarate Market - Global Industry Analysis.
4. Drug Patent Watch: LO LOESTRIN FE Drug Patent Profile.
5. Mayo Clinic: Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate (oral route).