ESTROSTEP FE Drug Patent Profile

When do Estrostep Fe patents expire, and when can generic versions of Estrostep Fe launch?

Estrostep Fe is a drug marketed by Apil and is included in one NDA.

The generic ingredient in ESTROSTEP FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for ESTROSTEP FE

US Patents:	0
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for ESTROSTEP FE
What excipients (inactive ingredients) are in ESTROSTEP FE?	ESTROSTEP FE excipients list
DailyMed Link:	ESTROSTEP FE at DailyMed

See drug prices for ESTROSTEP FE

US Patents and Regulatory Information for ESTROSTEP FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996		DISCN	Yes	No

Expired US Patents for ESTROSTEP FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996

International Patents for ESTROSTEP FE

See the table below for patents covering ESTROSTEP FE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203142	CONTRACEPTIVOS DE ESTROGENOS TITULADOS.

Supplementary Protection Certificates for ESTROSTEP FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

ESTROSTEP FE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ESTROSTEP Fe

Introduction

ESTROSTEP Fe, a graduated estrophasic combined oral contraceptive, has been a significant player in the contraceptive and acne treatment markets since its approval by the FDA in 1996. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Position and Indications

ESTROSTEP Fe is indicated for the prevention of pregnancy and the treatment of moderate acne vulgaris in females aged 15 years and older who have no known contraindications to oral contraceptive therapy[3].

Contraceptive Market

The contraceptive market is highly competitive, with numerous oral contraceptives available. However, ESTROSTEP Fe's unique graduated sequence of estrogen doses over a 21-day period, combined with a constant dose of progestogen, sets it apart. This formulation helps in maintaining hormonal balance and reducing side effects, making it a preferred choice for some users.

Acne Treatment Market

In addition to its contraceptive benefits, ESTROSTEP Fe is also approved for the treatment of moderate acne vulgaris. Clinical studies have shown that ESTROSTEP Fe significantly reduces acne lesions compared to placebo, making it a viable option for women seeking both contraceptive and dermatological benefits[3].

Financial Performance

Revenue and Sales

The financial performance of ESTROSTEP Fe is tied to its sales and market share within the contraceptive and acne treatment segments. While specific revenue figures for ESTROSTEP Fe are not publicly disclosed in recent years, it is known that the drug has contributed to the net sales of its manufacturers. For instance, revenue from ESTROSTEP Fe is reported within the broader financial performance of companies like Warner Chilcott, which has since been acquired by other pharmaceutical entities[2].

Generic Availability

As of the last update, all formulations of ESTROSTEP Fe have been discontinued, and there are no generic versions available in the market. This discontinuation can impact the drug's financial trajectory, as generic competition often drives down prices and market share for brand-name drugs[4].

Market Challenges

Competition

The oral contraceptive market is highly competitive, with many other brands and generic options available. This competition can erode market share and revenue for ESTROSTEP Fe.

Regulatory and Safety Concerns

Combined oral contraceptives, including ESTROSTEP Fe, come with contraindications such as a high risk of arterial or venous thrombotic diseases, especially in women who smoke over the age of 35 or have certain cardiovascular conditions. These safety concerns can affect prescribing rates and overall market performance[1].

Patient Preferences and Compliance

Patient compliance is crucial for the success of any contraceptive. The 28-day regimen of ESTROSTEP Fe, which includes seven non-hormonal ferrous fumarate tablets to facilitate ease of administration, can help in maintaining compliance. However, patient preferences for other formulations or methods of contraception can also impact the drug's market dynamics.

Financial Trajectory

Historical Performance

Historically, ESTROSTEP Fe has been a significant contributor to the revenue of its manufacturers. However, with the discontinuation of all its formulations, the drug's financial trajectory is likely to decline.

Impact of Discontinuation

The discontinuation of ESTROSTEP Fe formulations means that the drug will no longer generate revenue for its manufacturers. This discontinuation could be due to various factors, including declining market share, increased competition, or strategic decisions by the manufacturer.

Future Outlook

Given the discontinuation of ESTROSTEP Fe, the future financial outlook for this drug is bleak. The market will likely shift towards other available oral contraceptives and acne treatments, reducing any residual financial impact of ESTROSTEP Fe.

Key Takeaways

• Market Position: ESTROSTEP Fe is unique in its graduated estrogen sequence but faces intense competition in the contraceptive and acne treatment markets.
• Financial Performance: The drug has contributed to the revenue of its manufacturers but faces a declining financial trajectory due to discontinuation.
• Challenges: Safety concerns, competition, and patient preferences are significant challenges.
• Future Outlook: The discontinuation of ESTROSTEP Fe formulations indicates a diminishing financial role for the drug.

FAQs

What is ESTROSTEP Fe used for?

ESTROSTEP Fe is used for the prevention of pregnancy and the treatment of moderate acne vulgaris in females aged 15 years and older.

Why has ESTROSTEP Fe been discontinued?

All formulations of ESTROSTEP Fe have been discontinued, although the exact reasons are not specified. This could be due to declining market share, increased competition, or strategic decisions by the manufacturer.

What are the contraindications for ESTROSTEP Fe?

ESTROSTEP Fe should not be used in women who have a high risk of arterial or venous thrombotic diseases, such as those who smoke over age 35, have cerebrovascular disease, coronary artery disease, or a history of deep vein thrombosis or pulmonary embolism.

How does ESTROSTEP Fe compare to other oral contraceptives?

ESTROSTEP Fe has a unique graduated sequence of estrogen doses, which sets it apart from other oral contraceptives. However, it faces competition from numerous other brands and generic options.

What is the impact of generic availability on ESTROSTEP Fe?

Since all formulations of ESTROSTEP Fe have been discontinued, there are no generic versions available, which would otherwise have impacted its market share and revenue.

Sources

1. FDA Label for ESTROSTEP Fe - [Access Data FDA][1]
2. Morningstar Document Library - [Morningstar][2]
3. FDA Label for ESTROSTEP Fe (2017) - [Access Data FDA][3]
4. Generic Estrostep Fe Availability - [Drugs.com][4]