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Last Updated: December 22, 2024

ESTROGENS, CONJUGATED SYNTHETIC A - Generic Drug Details


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What are the generic drug sources for estrogens, conjugated synthetic a and what is the scope of freedom to operate?

Estrogens, conjugated synthetic a is the generic ingredient in two branded drugs marketed by Teva Womens and Aspen, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ESTROGENS, CONJUGATED SYNTHETIC A
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 25
Clinical Trials: 6
DailyMed Link:ESTROGENS, CONJUGATED SYNTHETIC A at DailyMed
Recent Clinical Trials for ESTROGENS, CONJUGATED SYNTHETIC A

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

SponsorPhase
Duramed ResearchPhase 4
Stanley Medical Research InstitutePhase 2
The AlfredPhase 2

See all ESTROGENS, CONJUGATED SYNTHETIC A clinical trials

Paragraph IV (Patent) Challenges for ESTROGENS, CONJUGATED SYNTHETIC A
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CENESTIN Tablets estrogens, conjugated synthetic a 0.3 mg, 0.45 mg and 0.9 mg 020992 1 2009-03-19
CENESTIN Tablets estrogens, conjugated synthetic a 0.625 mg 020992 1 2009-03-02
CENESTIN Tablets estrogens, conjugated synthetic a 1.25 mg 020992 1 2008-11-03

US Patents and Regulatory Information for ESTROGENS, CONJUGATED SYNTHETIC A

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-002 Mar 24, 1999 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-003 Mar 24, 1999 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Womens SYNTHETIC CONJUGATED ESTROGENS A estrogens, conjugated synthetic a CREAM;VAGINAL 021788-001 Nov 28, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-005 Feb 5, 2004 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-004 Mar 13, 2000 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-001 Jun 21, 2002 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

Expired US Patents for ESTROGENS, CONJUGATED SYNTHETIC A

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-004 Mar 13, 2000 ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-001 Jun 21, 2002 ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-003 Mar 24, 1999 ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-002 Mar 24, 1999 ⤷  Subscribe ⤷  Subscribe
Aspen CENESTIN estrogens, conjugated synthetic a TABLET;ORAL 020992-005 Feb 5, 2004 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

ESTROGENS, CONJUGATED SYNTHETIC A Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Conjugated Synthetic Estrogens A

Introduction

Conjugated Synthetic Estrogens A, such as those found in products like Cenestin and Enjuvia, are a crucial component of hormone replacement therapy (HRT) for postmenopausal women. These drugs are derived from plant sources, specifically yam and soy plants, and are designed to mimic the natural estrogens found in the body.

Market Overview

The market for conjugated estrogens, including both natural and synthetic forms, is driven by the increasing demand for effective treatments for menopausal symptoms and related health issues.

Patient Population

The primary market for Conjugated Synthetic Estrogens A consists of postmenopausal women experiencing moderate to severe vasomotor symptoms, vulvovaginal atrophy, and other menopause-related conditions. This demographic is significant, given the aging population globally and the rising awareness of menopause management[3][4].

Competitors

The market for conjugated estrogens is competitive, with both natural and synthetic products available. Natural products, such as Conjugated Equine Estrogens (CEEs) marketed under brands like Premarin, have been dominant for decades. However, synthetic alternatives like Cenestin and Enjuvia are gaining traction due to their plant-derived nature and similar efficacy profiles[1][3][4].

Financial Trajectory

Cost Savings and Healthcare Economics

Studies have shown that the use of conjugated estrogens can lead to significant cost savings in healthcare. For instance, a study published on PubMed indicated that women prescribed oral conjugated estrogens experienced a greater reduction in healthcare costs compared to untreated women. This reduction was particularly notable in inpatient stay costs, highlighting the economic benefits of HRT[2].

Market Size and Growth

The market for HRT, including conjugated estrogens, is expected to grow due to the increasing prevalence of menopause and the expanding awareness of available treatments. The global HRT market is projected to see substantial growth, driven by the rising demand for effective and safe treatments for menopausal symptoms.

Pricing and Accessibility

The pricing of Conjugated Synthetic Estrogens A can vary depending on the brand, formulation, and region. However, these products are generally more affordable than some of their natural counterparts, making them more accessible to a broader patient population. The FDA approval of these products has also led to increased competition, which can drive prices down and improve accessibility[1][4].

Regulatory Environment

FDA Approvals

Conjugated Synthetic Estrogens A have received FDA approvals, with Cenestin approved in March 1999 and Enjuvia in May 2004. These approvals have been crucial in establishing the safety and efficacy of these products in the market[4].

Safety and Efficacy

The regulatory environment emphasizes the need for rigorous clinical trials to establish the safety and efficacy of these drugs. The mechanism of action, metabolic pathways, and potential side effects are closely monitored to ensure that these products meet the required standards for patient safety and therapeutic effectiveness[1][3][4].

Clinical Indications and Usage

Treatment of Menopausal Symptoms

Conjugated Synthetic Estrogens A are primarily used to treat moderate to severe vasomotor symptoms and vulvovaginal atrophy associated with menopause. They are also indicated for the treatment of hypoestrogenism and the prevention of postmenopausal osteoporosis[1][3][4].

Dosage and Administration

These products are available in various formulations, including oral tablets and vaginal creams. The dosage cycles are often repeated for 3-6 months to establish a normal menstrual cycle, and the treatment may include sequential progestin to protect the endometrium[4].

Side Effects and Safety Profile

Common Side Effects

Common side effects include vaginal discharge, vaginitis, and changes in uterine bleeding patterns. Less frequent side effects can include cervical ectropion, cervical secretion changes, and libido changes[4].

Metabolic Impact

Conjugated estrogens can affect glucose metabolism, particularly in women with diabetes or those at risk of hyperglycemia. Monitoring for changes in glucose tolerance is recommended when initiating or discontinuing therapy[4].

Market Trends and Future Outlook

Increasing Demand for HRT

The demand for HRT is expected to increase as the global population ages and awareness about menopause management grows. This trend is likely to drive the market for Conjugated Synthetic Estrogens A, making them a significant player in the HRT market[3][5].

Advancements in Formulations

Continuous research and development in formulations and delivery methods are expected to improve the efficacy and safety profile of these products. New formulations, such as vaginal creams and patches, are being developed to provide more convenient and targeted therapy options[4].

Key Takeaways

  • Market Growth: The market for Conjugated Synthetic Estrogens A is expected to grow driven by the increasing demand for HRT.
  • Cost Savings: These products can lead to significant healthcare cost savings by reducing the need for hospitalizations and other medical interventions.
  • Regulatory Approvals: FDA approvals have been crucial in establishing the safety and efficacy of these products.
  • Clinical Indications: They are used to treat a range of menopausal symptoms and prevent postmenopausal osteoporosis.
  • Safety Profile: While generally safe, these products can have side effects and impact glucose metabolism, requiring careful monitoring.

FAQs

Q: What are Conjugated Synthetic Estrogens A used for?

A: Conjugated Synthetic Estrogens A are used to treat moderate to severe vasomotor symptoms, vulvovaginal atrophy, and other conditions associated with menopause.

Q: How are Conjugated Synthetic Estrogens A derived?

A: These estrogens are derived from plant sources, specifically yam and soy plants, and are chemically modified to mimic natural estrogens[1][4].

Q: What are the common side effects of Conjugated Synthetic Estrogens A?

A: Common side effects include vaginal discharge, vaginitis, and changes in uterine bleeding patterns. Less frequent side effects can include cervical ectropion and libido changes[4].

Q: Can Conjugated Synthetic Estrogens A affect glucose metabolism?

A: Yes, these products can affect glucose metabolism, particularly in women with diabetes or those at risk of hyperglycemia. Monitoring for changes in glucose tolerance is recommended[4].

Q: Are Conjugated Synthetic Estrogens A more cost-effective than natural estrogens?

A: Studies suggest that conjugated estrogens, including synthetic forms, can lead to significant healthcare cost savings by reducing the need for hospitalizations and other medical interventions[2].

Sources

  1. DrugBank: Synthetic Conjugated Estrogens, A - DrugBank.
  2. PubMed: Pharmacoeconomic and associated cost savings among postmenopausal women prescribed conjugated estrogens.
  3. DrugBank: Conjugated estrogens: Uses, Interactions, Mechanism of Action.
  4. Elsevier Healthcare Hub: Conjugated Estrogens.
  5. Menopause Journal: The 2022 hormone therapy position statement of The North American Menopause Society.

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