FEMHRT Drug Patent Profile

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

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

The generic ingredient in FEMHRT 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 FEMHRT

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

See drug prices for FEMHRT

See drug sales revenues for FEMHRT

Recent Clinical Trials for FEMHRT

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

Sponsor	Phase
Johns Hopkins University	N/A
Cedars-Sinai Medical Center	N/A
University of Alabama at Birmingham	N/A

See all FEMHRT clinical trials

US Patents and Regulatory Information for FEMHRT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005		DISCN	Yes	No
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-002	Oct 15, 1999		DISCN	Yes	No

Expired US Patents for FEMHRT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005	5,208,225
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-002	Oct 15, 1999	5,208,225

International Patents for FEMHRT

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

Country	Patent Number	Title	Estimated Expiration
Japan	S62205024	COMPOSITION CONTAINING CERTAIN COMBINATION
Japan	2942560
Canada	1300017	PREPARATION POUR PREVENIR L'OSTEOPOROSE (COMPOSITION FOR PREVENTING OSTEOPOROSIS)
Hong Kong	182795	Composition useful in the treatment of estrogen deficiencies
Germany	3787386

Supplementary Protection Certificates for FEMHRT

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

FEMHRT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FEMHRT

Introduction to FEMHRT

FEMHRT is a hormone replacement therapy (HRT) medication, specifically designed for postmenopausal women to treat moderate to severe vasomotor symptoms and prevent postmenopausal osteoporosis. It is a combination of norethindrone acetate and ethinyl estradiol, available in two strengths[4].

Market Context of Hormone Replacement Therapy (HRT)

The HRT market, which includes FEMHRT, is experiencing substantial growth driven by several key factors. The rising prevalence of menopause-related issues, increasing incidence of growth deficiency diseases, thyroid disorders, osteoporosis, and hypogonadism are all contributing to the demand for HRT products. Additionally, advancements in medical research, new product launches, and favorable reimbursement policies are bolstering market expansion[3].

Demographic Drivers

The aging population, particularly in developed countries, is a primary driver of growth in the HRT market. As the global population ages, the incidence of menopause and related conditions increases, fueling the demand for effective treatment options like FEMHRT. This demographic trend is expected to continue, providing a sustained growth trajectory for the HRT market[3].

Regulatory and Competitive Landscape

The HRT market is influenced by regulatory environments and competitive dynamics. The presence of several key pharmaceutical companies, including those that manufacture FEMHRT, such as Warner Chilcott (now part of AbbVie), Pfizer, and others, characterizes the competitive landscape. These companies are investing in research and development to enhance their product offerings and expand their market share. The rise of generic HRT products has also increased competition, making innovation and superior patient outcomes crucial for market differentiation[3].

Financial Performance of HRT Products

The financial performance of HRT products like FEMHRT is closely tied to the overall market dynamics. For instance, the loss of patent exclusivity for branded drugs can significantly impact revenues. When a drug like FEMHRT loses its patent protection, it becomes open to generic competition, which can lead to a decline in sales for the branded version. This was observed with other pharmaceutical products, such as Norvasc and Camptosar, which experienced significant revenue declines after losing U.S. exclusivity[2].

Generic Competition and Pricing

Generic competition plays a critical role in the financial trajectory of drugs like FEMHRT. While generics offer affordable alternatives, they can also lead to pricing pressures on branded products. However, some generic drugs have seen extraordinary price increases in recent years, which can affect the affordability and accessibility of these medications. For example, between 2013 and 2014, the prices of several generic drugs more than doubled, with some increasing by as much as 500% to 1000%[1].

Commercial Coverage and Revenue Impact

Commercial insurance coverage significantly influences the revenue of HRT products. For FEMHRT, achieving high levels of commercial insurance coverage is crucial for revenue growth. Companies like TherapeuticsMD, which also operate in the HRT space, have seen the impact of commercial insurance on their net revenue. For instance, TherapeuticsMD's product Imvexxy, another HRT medication, is expected to have its net revenue significantly affected by the establishment of full commercial insurance coverage[5].

Product Pricing and Net Revenue

The pricing strategy for FEMHRT, including its wholesale acquisition cost (WAC) and net revenue after discounts and patient savings programs, is critical for its financial performance. Similar to other HRT products, FEMHRT's pricing would need to balance profitability with affordability and competition. For example, TherapeuticsMD's Imvexxy has a WAC of $405 for starter packs and $180 for maintenance packs, with net revenues estimated at 60% of these values[5].

Challenges and Opportunities

Despite the growth potential, the HRT market, including FEMHRT, faces several challenges. Regulatory changes, such as the FDA's generic drug labeling rule, can impact the market dynamics. Additionally, the need for continuous innovation and the presence of generic competition pose significant challenges. However, opportunities arise from the increasing awareness of menopause management, advancements in medical research, and the growing elderly population[1][3].

Key Takeaways

• The HRT market, including FEMHRT, is driven by demographic shifts, advancements in medical research, and regulatory environments.
• Generic competition and pricing strategies significantly impact the financial trajectory of HRT products.
• Commercial insurance coverage is crucial for revenue growth.
• Continuous innovation and superior patient outcomes are essential for market differentiation.
• Regulatory changes and the rise of generic products present both challenges and opportunities.

FAQs

What is FEMHRT used for?

FEMHRT is used to treat moderate to severe vasomotor symptoms due to menopause and to prevent postmenopausal osteoporosis[4].

How does the aging population impact the HRT market?

The aging population increases the incidence of menopause and related conditions, fueling the demand for HRT products like FEMHRT[3].

What is the impact of generic competition on branded HRT products?

Generic competition can lead to a decline in sales for branded HRT products due to pricing pressures and increased affordability of generic alternatives[1].

How does commercial insurance coverage affect the revenue of HRT products?

Commercial insurance coverage significantly increases the net revenue of HRT products by ensuring a larger patient base can afford the medication[5].

What are the key challenges faced by the HRT market?

The HRT market faces challenges from regulatory changes, generic competition, and the need for continuous innovation to maintain market share[1][3].

Cited Sources:

1. Congressional Hearing: "Why Are Some Generic Drugs Skyrocketing in Price?" - U.S. Government Publishing Office.
2. Annual Report: "Pfizer Inc. 2008 Financial Report" - Annual Reports.
3. Market Report: "Global Hormone Replacement Therapy Market to Grow Substantially at a CAGR of 6% by 2030" - PR Newswire.
4. Prescribing Information: "Femhrt: Package Insert / Prescribing Information" - Drugs.com.
5. Investor Presentation: "Oppenheimer NDR_TXMD Final 3" - TherapeuticsMD Inc.