FEMTRACE Drug Patent Profile

Which patents cover Femtrace, and what generic alternatives are available?

Femtrace is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Femtrace

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FEMTRACE

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	12
Patent Applications:	536
DailyMed Link:	FEMTRACE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FEMTRACE

NDA:

021633

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for FEMTRACE

FEMTRACE is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No

Expired US Patents for FEMTRACE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004

International Patents for FEMTRACE

See the table below for patents covering FEMTRACE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04006057	PRODUCTOS FARMACEUTICOS ORALES QUE CONTIENEN 3-ALCANOATO INFERIOR DE 17-BETA-ESTRADIOL, METODO PARA ADMINISTRAR LOS MISMOS Y PROCESO DE PREPARACION. (ORAL PHARMACEUTICAL PRODUCTS CONTAINING 17beta-ESTRADIOL-3-LOWER ALKANOATE, METHOD OF ADMINISTERING THE SAME AND PROCESS OF PREPARATION.)
China	1273141
Norway	20042565
Australia	2002359758
Japan	2005517673

Supplementary Protection Certificates for FEMTRACE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306

FEMTRACE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Femtrace (Estradiol Acetate)

Introduction

Femtrace, a brand name for estradiol acetate, is a form of the female hormone estrogen used primarily to treat moderate to severe vasomotor symptoms due to menopause. Here, we will explore the market dynamics and financial trajectory of Femtrace, as well as the broader context of the estradiol market.

Market Size and Growth

The estradiol market, which includes products like Femtrace, is experiencing significant growth. The global estradiol gel market, for example, was valued at US$ 79 million in 2023 and is projected to reach US$ 127 million by 2030, with a compound annual growth rate (CAGR) of 7.3% during the forecast period 2024-2030[3].

Drivers of Growth

Increasing Incidence of Menopausal Symptoms

The rising incidence of menopausal symptoms such as hot flashes, vaginal dryness, and mood swings is a primary driver of the estradiol market. As women live longer and remain more active into later life stages, the demand for treatments that alleviate these symptoms is increasing[3].

Changing Cultural Views

Shifting cultural views toward women's health and menopause are also contributing to market growth. Menopause is increasingly seen as a normal stage of life rather than a disease, leading to greater acceptance and use of hormone replacement therapy (HRT) products like Femtrace[3].

Aging Population

The aging population, particularly in regions like North America, Europe, and the Asia-Pacific, is another significant factor driving market expansion. Countries with rapidly aging populations, such as South Korea and Japan, are expected to drive market growth as more women seek effective treatments for menopausal symptoms[3].

Regional Market Dynamics

North America

North America is a well-established market for estradiol products, driven by a high number of women experiencing menopause and a strong healthcare infrastructure that supports industry growth[3].

Europe

Europe also sees significant demand due to its aging population and progressive views on women's health. The region's healthcare infrastructure further supports the market expansion[3].

Asia-Pacific

The Asia-Pacific region offers substantial growth opportunities, particularly in countries like South Korea and Japan. As awareness of menopausal health issues and HRT increases, the demand for estradiol products is expected to rise[3].

Product Specifics: Femtrace

Formulation and Use

Femtrace is available in oral tablet form and is used to treat moderate to severe vasomotor symptoms due to menopause. It was approved by the FDA in 2004 but has since had all its formulations (0.45 mg, 0.9 mg, and 1.8 mg) discontinued[4].

Side Effects and Adverse Reactions

Common side effects of Femtrace include vaginal hemorrhage, breast tenderness, vaginal discharge, and intermenstrual bleeding. Postmarketing reports have also identified other adverse reactions such as changes in vaginal bleeding patterns, breakthrough bleeding, and increases in the size of uterine leiomyomata[1].

Financial Performance

Revenue and Sales

While Femtrace itself is no longer in production, the broader estradiol market is experiencing robust financial growth. Companies involved in women's healthcare, such as Femasys, have reported significant sales increases. For example, Femasys saw a 22.0% increase in sales to $1,047,532 for the nine months of 2024, driven by products like FemaSeed and FemVue[5].

Research and Development

Investments in research and development are crucial for the financial growth of companies in the estradiol market. Femasys, for instance, increased its R&D expenses by $912,406 to $6,049,847 for the nine months of 2024, reflecting a focus on new products and approvals[5].

Market Segments

By Type

The estradiol market is segmented by type, including estradiol gel and transdermal patches. These products are further segmented by application (e.g., pharmacy sales, online sales) and administration type (e.g., skin administration, vaginal administration)[3].

By Geography

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its unique dynamics and growth prospects, with the Asia-Pacific region offering significant opportunities due to its aging population and increasing awareness of HRT[3].

Challenges and Opportunities

Regulatory Hurdles

Regulatory challenges can impact market growth. However, as regulatory hurdles are removed and healthcare infrastructure improves, especially in the Asia-Pacific region, the market is expected to expand further[3].

Increasing Awareness

Increasing awareness of menopausal health and HRT among both healthcare providers and patients presents a significant opportunity for market growth. Educational initiatives and marketing campaigns can further drive this awareness[3].

Key Takeaways

• The estradiol market, including products like Femtrace, is growing significantly due to increasing demand for HRT.
• The market is driven by the rising incidence of menopausal symptoms, changing cultural views, and an aging population.
• North America, Europe, and the Asia-Pacific are key regions driving market growth.
• Despite Femtrace being discontinued, the broader estradiol market continues to see robust financial growth and significant investments in R&D.
• Market segments are defined by type, application, and geography.

FAQs

What is Femtrace used for?

Femtrace is used to treat moderate to severe vasomotor symptoms due to menopause.

Why has Femtrace been discontinued?

All formulations of Femtrace (0.45 mg, 0.9 mg, and 1.8 mg) have been discontinued, although the exact reasons are not specified in the available sources[4].

What are the common side effects of Femtrace?

Common side effects include vaginal hemorrhage, breast tenderness, vaginal discharge, and intermenstrual bleeding[1].

How is the estradiol market segmented?

The market is segmented by type (e.g., estradiol gel, transdermal patches), application (e.g., pharmacy sales, online sales), and geography (e.g., North America, Europe, Asia-Pacific)[3].

What drives the growth of the estradiol market?

The growth is driven by the rising incidence of menopausal symptoms, changing cultural views toward women's health, and an aging population[3].

Sources

1. RxList: Femtrace (Estradiol Acetate Tablets): Side Effects, Uses...
2. GlobeNewswire: Femasys Announces Financial Results for Quarter Ended September 30, 2024...
3. DrugPatentWatch: Generic ESTRADIOL INN entry, drug patent expiration information...
4. Drugs.com: Generic Femtrace Availability
5. StockTitan: Femasys Announces Financial Results for Quarter Ended September 30...