ENJUVIA Drug Patent Profile

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

Enjuvia is a drug marketed by Aspen and is included in one NDA.

The generic ingredient in ENJUVIA is estrogens, conjugated synthetic b. There are three drug master file entries for this compound. Additional details are available on the estrogens, conjugated synthetic b profile page.

Summary for ENJUVIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENJUVIA
What excipients (inactive ingredients) are in ENJUVIA?	ENJUVIA excipients list
DailyMed Link:	ENJUVIA at DailyMed

See drug sales revenues for ENJUVIA

Recent Clinical Trials for ENJUVIA

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

Sponsor	Phase
Duramed Research	Phase 4
Duramed Research	Phase 3

See all ENJUVIA clinical trials

US Patents and Regulatory Information for ENJUVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-001	Dec 20, 2004		DISCN	No	No
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-005	Apr 27, 2007		DISCN	No	No
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-002	Dec 20, 2004		DISCN	No	No
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-003	May 10, 2004		DISCN	No	No

Expired US Patents for ENJUVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-004	May 10, 2004	6,855,703
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-003	May 10, 2004	6,660,726
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-004	May 10, 2004	6,660,726
Aspen	ENJUVIA	estrogens, conjugated synthetic b	TABLET;ORAL	021443-001	Dec 20, 2004	6,660,726

International Patents for ENJUVIA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2011256181	PHARMACEUTICAL COMPOSITION OF CONJUGATED ESTROGEN AND METHOD OF ANALYZING MIXTURE CONTAINING ESTROGENIC COMPOUND
Japan	2004500396
European Patent Office	1267852
South Korea	20070045364

ENJUVIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ENJUVIA

Introduction

ENJUVIA, an oral treatment for moderate to severe vasomotor symptoms associated with menopause, is a significant player in the menopausal disorder treatment market. To understand its market dynamics and financial trajectory, it is essential to delve into various factors influencing its growth, challenges, and financial performance.

Market Size and Growth

The menopausal disorder treatment market, within which ENJUVIA operates, is projected to grow substantially. From a base year market size of USD 11,860.10 million in 2021, the market is expected to reach USD 21,790.13 million by 2029, driven by the rising prevalence of menopausal disorders and increasing healthcare expenditure[1].

Drivers of Growth

Several factors contribute to the growth of the market for ENJUVIA and similar treatments:

• Rising Prevalence of Menopausal Disorders: The increasing number of women entering menopause is a significant driver, as it expands the potential patient pool for treatments like ENJUVIA[1].
• Increasing Healthcare Expenditure: Higher investment in healthcare infrastructure and research activities enhances the market's growth potential[1].
• Technological Advancements: Advances in medical technology and the launch of innovative products, including new formulations and delivery methods, are expected to boost the market[1].

Market Segmentation

The menopausal disorder treatment market is segmented based on several criteria:

• Type: Hormonal and non-hormonal therapies. ENJUVIA falls under hormonal therapy, which is a major segment[1].
• Menopause Symptoms: Treatments are categorized based on symptoms such as vasomotor symptoms, atrophic vaginitis, osteoporosis, and others. ENJUVIA is specifically indicated for vasomotor symptoms[1][4].
• Dosage Form: ENJUVIA is available in oral form, which is one of the common dosage forms in this market[1].

Regional Analysis

The market for menopausal disorder treatments, including ENJUVIA, varies by region:

• North America: Dominates the market due to well-established healthcare infrastructure and the presence of major key players. The increasing elderly female population in this region further propels market growth[1].
• Asia-Pacific: Expected to grow significantly due to the rising prevalence of menopausal disorders and improvements in healthcare infrastructure[1].

Financial Performance of ENJUVIA

ENJUVIA is a product of Teva Pharmaceutical Industries Ltd., a major player in the pharmaceutical industry.

Revenue Contribution

ENJUVIA contributes to Teva's revenue, although the exact figures for ENJUVIA alone are not separately disclosed in the annual reports. However, Teva's overall revenue from its women's health segment, which includes ENJUVIA, is part of the company's broader financial performance.

Operating and Financial Review

Teva's financial reports indicate significant revenue from its pharmaceutical products, including those in the women's health category. For instance, in 2012, Teva reported net revenues of $20,317 million, with a gross profit of $10,652 million[2].

Research and Development

Teva invests heavily in research and development, which is crucial for the development and commercialization of products like ENJUVIA. In 2012, Teva's research and development expenses were $1,283 million, reflecting the company's commitment to innovation and product development[2].

Challenges and Restraints

Despite the growth potential, several challenges affect the market for ENJUVIA:

• High Cost of Hormonal Therapy: The high cost associated with hormonal therapies can obstruct market growth, making these treatments less accessible to some patients[1].
• Side Effects and Lack of Awareness: Side effects of medications and a lack of awareness about menopausal disorder treatments can further impede market growth[1].
• Regulatory and Safety Standards: Products must receive regulatory approval and comply with safety standards, which can be a barrier to entry and ongoing compliance[2].

Competitive Landscape

The market for menopausal disorder treatments is competitive, with several players offering various treatments:

• Generic Competition: The entry of generic versions of hormonal therapies can reduce prices and impact the market share of branded products like ENJUVIA. However, generic prices tend to fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[3].

Key Takeaways

• The menopausal disorder treatment market is growing due to increasing prevalence and healthcare expenditure.
• ENJUVIA, as a hormonal therapy, benefits from this growth but faces challenges such as high costs and side effects.
• Regional markets, especially North America and Asia-Pacific, are significant for ENJUVIA's growth.
• Teva's financial performance is influenced by its investment in research and development and the competitive landscape of the pharmaceutical industry.

FAQs

What is ENJUVIA used for?

ENJUVIA is used for the treatment of moderate to severe vasomotor symptoms associated with menopause[4].

Who manufactures ENJUVIA?

ENJUVIA is manufactured by Teva Pharmaceutical Industries Ltd.[2].

What are the key drivers of the menopausal disorder treatment market?

The key drivers include the rising prevalence of menopausal disorders, increasing healthcare expenditure, and technological advancements[1].

What are the main challenges facing ENJUVIA in the market?

Challenges include the high cost of hormonal therapy, side effects of medications, and lack of awareness about menopausal disorder treatments[1].

How does the competitive landscape affect ENJUVIA?

The entry of generic versions and competition from other hormonal therapies can impact ENJUVIA's market share and pricing[3].

Sources

1. Global Menopausal Disorder Treatment Market – Industry Trends ... - Data Bridge Market Research
2. United States Securities and Exchange Commission - Teva Pharmaceutical Industries Ltd. 20F
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. Center for Drug Evaluation and Research - FDA
5. United States Securities and Exchange Commission - Teva Pharmaceutical Industries Ltd. 20F (2013)