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Last Updated: December 24, 2024

ESTRACE Drug Patent Profile


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

Estrace is a drug marketed by Allergan and Bristol Myers Squibb and is included in four NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Estrace

A generic version of ESTRACE was approved as estradiol by BARR LABS INC on October 22nd, 1997.

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Drug patent expirations by year for ESTRACE
Drug Prices for ESTRACE

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Drug Sales Revenue Trends for ESTRACE

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Recent Clinical Trials for ESTRACE

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

SponsorPhase
University of WashingtonPhase 2
Breast Cancer Research FoundationPhase 2
Dartmouth-Hitchcock Medical CenterPhase 1

See all ESTRACE clinical trials

Pharmacology for ESTRACE
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ESTRACE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ESTRACE estradiol CREAM;VAGINAL 086069-001 Jan 31, 1984 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 084500-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 081295-001 Jun 30, 1993 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 084499-001 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

ESTRACE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estrace

Introduction to Estrace

Estrace, a formulation of the female sex hormone estradiol, is widely used to treat conditions such as vaginal atrophy related to menopause. This medication is available in various forms, including creams, vaginal rings, and transdermal patches. Here, we delve into the market dynamics and financial trajectory of Estrace, highlighting key factors influencing its pricing, market growth, and patient access.

Market Size and Growth

The global estradiol market, which includes Estrace, is projected to experience significant growth. The market is expected to witness a Compound Annual Growth Rate (CAGR) of 6.8% from 2021 to 2027, driven by increasing demand for menopausal hormone therapy and the rising incidence of women's health-related disorders[4].

Segment Analysis

The estradiol market is segmented based on type, route of administration, indication, and geographical regions. The market includes various forms of estradiol, such as transdermal patches, creams, and vaginal rings. The transdermal patches segment, for instance, is categorized by dosage (25 mg/day, 50 mg/day, 75 mg/day, 100 mg/day) and is expected to see substantial growth due to its convenience and efficacy[3].

Pricing Trends

The prices of Estrace and other estradiol formulations have been on the rise over the past few years. For example, Allergan's Estrace Cream increased from about $200 per tube in 2014 to around $330 per tube in 2018. Similarly, Pfizer's Estring vaginal ring rose from less than $300 in 2014 to over $500 in 2018[1].

Impact of Generic Competition

The introduction of generic versions has somewhat mitigated the price increases. After Estrace Cream lost its patent protections in December 2017, generics from companies like Mylan and Teva entered the market, capturing about 75% of the market share. This competition has led to slightly lower prices for generic versions, such as around $280 per tube for generic Estrace Cream[1].

Patient Access and Financial Burden

Despite the availability of generics, many patients still face significant financial burdens. High out-of-pocket costs, exacerbated by higher deductibles and copays, have forced some patients to seek alternatives like buying medications from overseas outlets. For instance, some patients purchase estradiol from overseas for about $80 for a three-month supply, significantly cheaper than the domestic prices[1].

Patient Assistance Programs

To alleviate the financial strain, pharmaceutical companies and advocacy groups offer patient assistance programs. Pfizer, for example, provides patient assistance programs or free medications for eligible patients. The Rx Advocates also offer a fixed pricing model, where patients can pay a fixed cost of $80 per month for Estrace, regardless of retail price fluctuations[1][2].

Market Dynamics

Drivers

  • Increasing Demand: The rising number of women experiencing menopause and related health issues drives the demand for estradiol treatments.
  • Medical Tourism: Growing medical tourism in regions like Asia Pacific contributes to the market growth[4].
  • Convenience and Efficacy: The convenience and efficacy of transdermal patches and other formulations attract more patients.

Restraints

  • Side Effects: Side effects such as anxiety, abdominal cramping, and breast enlargement can deter some patients from using estradiol drugs[4].
  • COVID-19 Impact: The COVID-19 pandemic led to a decline in new diagnoses and hospital visits, affecting the market negatively in 2020[4].

Opportunities

  • Generic Competition: The entry of generic versions can lead to lower prices and increased market competition.
  • Expanding Market: The global estradiol market is expected to expand significantly over the forecast period, offering opportunities for growth[4].

Challenges

  • Taboo and Stigma: The lack of public discussion about vaginal atrophy and menopause-related issues can limit awareness and advocacy for affordable treatments[1].
  • Regulatory and Market Dynamics: Pricing decisions are influenced by competitive and market dynamics, which can affect the affordability of the medication[1].

Financial Trajectory

Revenue and Sales

Estrace Cream generated $367 million in sales for Allergan in the year following its patent loss. The global drugs for hormonal replacement therapy market, which includes estradiol, is expected to grow from $14.76 billion in 2020 to $16.77 billion by 2025 at a CAGR of 3%[1][5].

Cost Factors

The cost of Estrace is influenced by several factors, including dosage, geographic location, and the patient's health insurance plan. For instance, the average retail cost of Estrace as of April 2024 is around $588.00, with prices varying significantly based on these factors[2].

Key Takeaways

  • Market Growth: The global estradiol market is expected to grow significantly, driven by increasing demand and the convenience of various formulations.
  • Pricing Trends: Prices for Estrace and similar drugs have risen, but generic competition has provided some relief.
  • Patient Access: High out-of-pocket costs remain a challenge, but patient assistance programs and advocacy groups offer solutions.
  • Market Dynamics: The market is influenced by drivers such as increasing demand and medical tourism, as well as restraints like side effects and the COVID-19 pandemic.

FAQs

Q: Why have the prices of Estrace and other estradiol formulations increased over the years?

A: The prices have increased due to various factors, including market dynamics, the lack of generic competition until recently, and the companies' pricing strategies.

Q: How do patient assistance programs help in making Estrace more affordable?

A: Patient assistance programs, such as those offered by Pfizer and The Rx Advocates, provide fixed pricing models or free medications for eligible patients, significantly reducing their out-of-pocket costs.

Q: What is the impact of generic competition on the pricing of Estrace?

A: The introduction of generic versions has led to slightly lower prices, capturing a significant market share and providing some relief to patients.

Q: How does the geographic location affect the cost of Estrace?

A: The cost of Estrace varies significantly based on geographic location due to factors such as local market dynamics, healthcare infrastructure, and economic conditions.

Q: What are the side effects of estradiol drugs that could affect their market growth?

A: Side effects such as anxiety, abdominal cramping, breast enlargement, and others may deter some patients from using estradiol drugs, potentially restraining market growth.

Sources

  1. FiercePharma: "Women's hormone drug prices have climbed for years, but there hasn't been a controversy. Why?"
  2. The Rx Advocates: "Estrace Coupon & Assistance Programs – Cost $70/month"
  3. Market Research Intellect: "Estradiol Transdermal Patches Market Size, Scope And Forecast"
  4. MarketStatsville: "Estradiol Market Scope Analysis and Forecast Period by 2027"
  5. GlobeNewswire: "Global Drugs For Hormonal Replacement Therapy Market (2021 to 2030)"

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