ESTRASORB Drug Patent Profile

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

Estrasorb is a drug marketed by Exeltis Usa Inc and is included in one NDA.

The generic ingredient in ESTRASORB is estradiol hemihydrate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol hemihydrate profile page.

Summary for ESTRASORB

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	4,876
DailyMed Link:	ESTRASORB at DailyMed

See drug sales revenues for ESTRASORB

US Patents and Regulatory Information for ESTRASORB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exeltis Usa Inc	ESTRASORB	estradiol hemihydrate	EMULSION;TOPICAL	021371-001	Oct 9, 2003		DISCN	Yes	No

Expired US Patents for ESTRASORB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exeltis Usa Inc	ESTRASORB	estradiol hemihydrate	EMULSION;TOPICAL	021371-001	Oct 9, 2003

International Patents for ESTRASORB

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0806894
China	1179698
Mexico	9705663	NANOPARTICULAS MICELARES. (MICELLAR NANOPARTICLES.)

Supplementary Protection Certificates for ESTRASORB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517

ESTRASORB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ESTRASORB

Introduction to ESTRASORB

ESTRASORB, an estradiol topical emulsion, is a medication designed to treat moderate to severe vasomotor symptoms associated with menopause. It is applied topically to deliver estradiol into the bloodstream, providing relief from symptoms such as hot flashes and night sweats[2][4].

Market Size and Growth

The global hormonal replacement therapy (HRT) market, which includes products like ESTRASORB, is experiencing significant growth. The market size is projected to increase from $11.13 billion in 2021 to $15.25 billion by 2026, at a compound annual growth rate (CAGR) of 6.2%[1].

Drivers of Market Growth

Several factors are driving the growth of the HRT market, including:

Aging Population and Menopause

The increasing population of aging and postmenopausal women is a major driver. As women age, the demand for HRT products to manage menopausal symptoms rises[1].

Advancements in Therapies

The introduction of new and effective therapies, such as transdermal sprays and gels, is enhancing market growth. For example, the launch of Lenzetto (estradiol spray) by Gedeon Richter in 2020 has contributed to the expansion of the transdermal segment[3].

Regulatory Approvals and Launches

Continuous regulatory approvals and the launch of various HRT products are boosting the market. For instance, approvals for new therapies and formulations, especially in regions like North America and Asia Pacific, are driving market expansion[3].

Route of Administration

ESTRASORB is administered topically, which is a segment anticipated to register a significant CAGR during the forecast period. The transdermal route of administration is gaining popularity due to its effectiveness and minimal risk profile compared to other routes[3].

Competitive Landscape

The HRT market is dominated by key players such as Novo Nordisk A/S and Pfizer Inc. While these companies are primarily known for their growth hormone and other HRT products, the presence of companies like Allergan (the manufacturer of ESTRASORB) indicates a competitive and diverse market landscape[3].

Distribution Channels

The distribution of HRT products, including ESTRASORB, is primarily through hospital pharmacies and retail pharmacies. The rise in the number of pharmacies and drug stores, especially in the U.S., is facilitating the rapid supply of these drugs, contributing to market growth[3].

Regional Market Analysis

North America

North America is expected to dominate the global HRT market due to the high prevalence of menopause and growth hormone deficiency disorders, along with high awareness and regulatory approvals in the region. The market size in North America stood at $8.35 billion in 2023[3].

Asia Pacific

The Asia Pacific region is emerging as a significant contributor to the HRT market, driven by increasing awareness, unmet medical needs, and changes in reimbursement policies. This region is expected to have one of the highest CAGRs in the near future[3].

Financial Trajectory

Given the overall growth of the HRT market, ESTRASORB is likely to benefit from the increasing demand for menopausal symptom relief. Here are some key financial indicators:

Market Share

While specific financial data for ESTRASORB is not provided, the product's inclusion in the broader HRT market suggests it will contribute to the market's overall revenue growth. The global HRT market is projected to grow from $16.91 billion in 2024 to $27.52 billion by 2032 at a CAGR of 6.3%[3].

Revenue Growth

The success of ESTRASORB can be inferred from the clinical efficacy data, which shows significant relief in vasomotor symptoms. For instance, ESTRASORB was statistically better than placebo in reducing the frequency and severity of hot flashes at weeks 4 and 12[2].

Challenges and Risks

Despite the positive market dynamics, there are challenges and risks associated with HRT products like ESTRASORB:

Health Risks

ESTRASORB, like other estrogen therapies, carries risks such as endometrial cancer, cardiovascular disorders, probable dementia, and breast cancer. These risks necessitate periodic re-evaluation of treatment necessity[4].

Regulatory Scrutiny

HRT products are under continuous regulatory scrutiny. Any changes in regulatory policies or adverse event reports can impact the market and financial performance of these products.

Key Takeaways

• The global HRT market, including products like ESTRASORB, is expected to grow significantly due to an aging population and advancements in therapies.
• The transdermal route of administration is gaining popularity, which benefits ESTRASORB.
• North America and Asia Pacific are key regions driving market growth.
• Despite growth, HRT products face challenges related to health risks and regulatory scrutiny.

FAQs

1. What is ESTRASORB used for? ESTRASORB is used for the treatment of moderate to severe vasomotor symptoms associated with menopause.

2. How is ESTRASORB administered? ESTRASORB is administered topically as an emulsion, applied to the thighs and calves.

3. What are the potential health risks associated with ESTRASORB? ESTRASORB carries risks such as endometrial cancer, cardiovascular disorders, probable dementia, and breast cancer.

4. Which regions are driving the growth of the HRT market? North America and Asia Pacific are the key regions driving the growth of the HRT market.

5. What is the projected growth rate of the global HRT market? The global HRT market is projected to grow at a CAGR of 6.3% from 2024 to 2032.

Cited Sources

1. The Business Research Company, "Drugs For Hormonal Replacement Therapy Global Market Report 2022".
2. FDA, "Estrasorb™ (estradiol topical emulsion) Rx only Prescribing Information".
3. Fortune Business Insights, "Hormone Replacement Therapy Market Size, Global Report 2032".
4. FDA, "ESTRASORB® (estradiol topical emulsion) for topical use".
5. Transparency Market Research, "Hormone Replacement Therapy Market Size, Trends 2034".