You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

DELESTROGEN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Delestrogen, and when can generic versions of Delestrogen launch?

Delestrogen is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in DELESTROGEN is estradiol valerate. There are seventy-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Delestrogen

A generic version of DELESTROGEN was approved as estradiol valerate by AM REGENT on January 19th, 2010.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for DELESTROGEN?
  • What are the global sales for DELESTROGEN?
  • What is Average Wholesale Price for DELESTROGEN?
Summary for DELESTROGEN
Drug patent expirations by year for DELESTROGEN
Drug Prices for DELESTROGEN

See drug prices for DELESTROGEN

Drug Sales Revenue Trends for DELESTROGEN

See drug sales revenues for DELESTROGEN

Recent Clinical Trials for DELESTROGEN

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

SponsorPhase
National Center for Advancing Translational Science (NCATS)Phase 3
Maire Mac BridePhase 3

See all DELESTROGEN clinical trials

Pharmacology for DELESTROGEN
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for DELESTROGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-002 Approved Prior to Jan 1, 1982 AO RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-004 Approved Prior to Jan 1, 1982 AO RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DELESTROGEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Delestrogen (Estradiol Valerate)

Introduction

Delestrogen, known generically as estradiol valerate, is a well-established estrogen medication with a long history of use in various therapeutic areas, including hormone replacement therapy (HRT) for menopausal symptoms, hormone therapy for transgender individuals, and hormonal birth control. Here, we delve into the market dynamics and financial trajectory of Delestrogen.

Historical Context and Regulatory Approval

Estradiol valerate was first approved in the United States in July 1954, making it one of the earliest drugs in its class to receive regulatory approval. This early approval has contributed to its widespread acceptance and use globally[1][4].

Market Size and Growth

The market for estradiol valerate, as part of the broader estradiol market, 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 valerate 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 HRT products like Delestrogen[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 such as South Korea and Japan, with rapidly aging populations, are expected to drive demand for estradiol valerate as more women seek effective treatments for menopausal symptoms[3].

Regional Market Dynamics

North America

North America is a well-established market for estradiol valerate, driven by a high number of women experiencing menopause and a strong healthcare infrastructure that supports industry growth. Companies like Endo International Plc, which develops and markets Delestrogen, have a significant presence in this region[1][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 of estradiol valerate products[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 valerate is expected to rise[3].

Competitive Landscape

The competitive landscape for estradiol valerate is characterized by the dominance of several major pharmaceutical companies. Companies like Bayer AG, Pfizer Inc., and Mochida Pharmaceutical Co., Ltd. have shown significant growth and made substantial progress in research and development (R&D) in the estrogen receptor (ER) target area[1].

Financial Performance

Revenue and Sales

The financial performance of companies in the estradiol valerate market is robust. For instance, the growth in women's healthcare products, including hormone replacement therapies, has contributed to significant revenue increases for companies like Fuji Pharma Co., Ltd.[3].

Research and Development

Investments in R&D are also driving financial growth. Companies are focusing on new products and approvals, which contribute to increased revenues and profitability. The approval of estradiol valerate in various global markets, including China, further highlights its global reach and acceptance[1][3].

Routes of Administration and Formulations

Delestrogen is available in various formulations, including oral tablets and intramuscular injections. The versatility in routes of administration (by mouth, sublingual, intramuscular injection, subcutaneous injection) makes it a preferred option for different patient needs[4].

Clinical Applications

Estradiol valerate is used in several clinical applications:

  • Hormone Replacement Therapy (HRT): For menopausal symptoms and low estrogen levels.
  • Hormone Therapy for Transgender People: As part of gender-affirming treatment.
  • Hormonal Birth Control: In combination with progestins.
  • Treatment of Prostate Cancer: As part of hormone therapy[4].

Market Trends and Future Outlook

Emerging Market Trends

The COVID-19 pandemic has accelerated certain market trends, such as the increased use of retail and online distribution channels. Companies like TherapeuticsMD Inc. have adjusted their strategies to capitalize on these trends, which could impact the market for estradiol valerate positively[2].

Innovation and R&D

The pharmaceutical industry is witnessing intense competition and innovation, particularly in the development of small molecule drugs and PROTACs (proteolysis-targeting chimeras). This innovation is expected to drive future growth in the estradiol valerate market[1].

Key Takeaways

  • The estradiol valerate market 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.
  • The competitive landscape includes several major pharmaceutical companies.
  • Financial performance is robust, with significant revenue growth and investments in R&D.
  • Delestrogen is available in various formulations and is used in multiple clinical applications.

FAQs

What is Delestrogen used for?

Delestrogen (estradiol valerate) is used in hormone replacement therapy for menopausal symptoms, hormone therapy for transgender people, and in hormonal birth control. It is also used in the treatment of prostate cancer[4].

Who manufactures Delestrogen?

Delestrogen is developed and marketed by Endo International Plc, a pharmaceutical company specializing in various therapeutic areas[1].

What are the different routes of administration for Delestrogen?

Delestrogen can be administered by mouth, sublingually, via intramuscular injection, or subcutaneously[4].

How has the COVID-19 pandemic impacted the market for Delestrogen?

The COVID-19 pandemic has accelerated market trends such as the increased use of retail and online distribution channels, which could positively impact the market for Delestrogen[2].

What are the key regions driving the growth of the estradiol valerate market?

The key regions driving the growth of the estradiol valerate market include North America, Europe, and the Asia-Pacific[3].

Sources

  1. Synapse by Patsnap: Estradiol valerate: Detailed Review of its Transformative R&D Success.
  2. TherapeuticsMD Inc: June 2020 - TherapeuticsMD Inc.
  3. Drug Patent Watch: Generic ESTRADIOL INN entry, drug patent expiration information.
  4. Wikipedia: Estradiol valerate.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.