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Last Updated: December 23, 2024

GONADORELIN HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for gonadorelin hydrochloride and what is the scope of freedom to operate?

Gonadorelin hydrochloride is the generic ingredient in one branded drug marketed by Hikma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for GONADORELIN HYDROCHLORIDE
Recent Clinical Trials for GONADORELIN HYDROCHLORIDE

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

SponsorPhase
Huashan HospitalN/A
Los Angeles Biomedical Research InstituteEarly Phase 1
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterEarly Phase 1

See all GONADORELIN HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for GONADORELIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-002 Sep 30, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-003 Sep 30, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-001 Sep 30, 1982 DISCN No 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 GONADORELIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-001 Sep 30, 1982 3,947,569 ⤷  Subscribe
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-003 Sep 30, 1982 4,110,438 ⤷  Subscribe
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-003 Sep 30, 1982 3,947,569 ⤷  Subscribe
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-002 Sep 30, 1982 4,110,438 ⤷  Subscribe
Hikma FACTREL gonadorelin hydrochloride INJECTABLE;INJECTION 018123-001 Sep 30, 1982 4,110,438 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

GONADORELIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Gonadorelin Hydrochloride

Introduction

Gonadorelin hydrochloride, a synthetic peptide analogue of gonadotropin-releasing hormone (GnRH), is a crucial drug in the treatment of various hormonal and fertility-related conditions. The market for gonadorelin hydrochloride is influenced by several key factors, including advancements in healthcare, regulatory environments, and demographic changes.

Market Size and Forecast

The gonadorelin market is experiencing significant growth, driven by increasing demand for fertility treatments and hormonal therapies. As of 2023, the gonadorelin acetate market was valued at USD 100 billion and is projected to reach USD 147.4 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[4].

Drivers of Market Growth

Growing Knowledge and Diagnosis

Improved diagnostic methods and a better understanding of hormonal abnormalities have led to more people receiving diagnoses for conditions that require gonadorelin therapy. This increased awareness and diagnosis rate are propelling the market's growth[1].

Improvements in Healthcare Infrastructure

Enhancements in healthcare infrastructure, particularly in emerging economies, have made diagnosis and treatment more accessible. This expansion in healthcare access is a significant driver for the gonadorelin market[1].

Aging Population

The global aging population is experiencing more age-related hormonal illnesses such as menopause and andropause, which increases the demand for therapies based on gonadorelin[1].

Technological Advancements

Ongoing research and development have led to the creation of new formulations, delivery systems, and more potent forms of gonadorelin. These advancements are expected to increase the market potential of the drug[1].

Regulatory Environment

Regulatory approvals and norms play a critical role in the market dynamics of gonadorelin. Changes in regulations, including approval procedures and reimbursement guidelines, can significantly impact market demand[1].

Market Segmentation

By Application

The gonadorelin acetate market is segmented into various applications, including gonadorelin acetate injections, nasal sprays, and capsules. The market also includes segments for fertility treatments, hormone replacement, diagnostic testing, and endometriosis[4].

By Geography

The market is analyzed across different geographical regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region has its own market conditions and demand dynamics[1][4].

Key Players

The global gonadorelin market includes several major players such as Ferring, Xuchang Shangke Chemical, Bachem, Aspen Oss, Shenzhen JYMed Technology, Toronto Research Chemicals, LKT Laboratories, Hemmo Pharmaceutical, Angle BioPharma, and Merck. These companies influence market competitiveness through price strategies, product innovation, and market penetration[1].

Therapeutic Uses

Gonadorelin is used in various therapeutic applications, including the treatment of primary hypothalamic amenorrhea, hypogonadotropic hypogonadism, delayed puberty, cryptorchidism, and infertility. Unlike other GnRH analogues, gonadorelin is not used to suppress sex hormone production but rather to induce the secretion of gonadotropins such as follicle-stimulating hormone (FSH) and luteinizing hormone (LH)[2].

Pharmacology

Gonadorelin acts as an agonist of the GnRH receptor, stimulating the pituitary gland to release FSH and LH, which in turn increase sex hormone production by the gonads. It has a short distribution half-life of 2 to 10 minutes and a terminal half-life of 10 to 40 minutes, metabolized by hydrolysis into smaller peptide components[2].

Challenges and Limitations

Strict Regulatory Requirements

The market growth of gonadorelin is hindered by strict safety and efficacy standards and prolonged approval procedures. These regulatory barriers can delay the release of new gonadorelin products into the market[1].

Exorbitant Treatment Cost

The high cost of gonadorelin treatments, especially for those without sufficient insurance, restricts patient access to care, particularly in underdeveloped nations or areas with inadequate medical resources[1].

Side Effects and Safety Issues

Like any prescription medication, gonadorelin treatments can have side effects or safety issues. Adverse responses or safety concerns can affect market demand and patient compliance[1].

Restricted Therapeutic Indications

Gonadorelin's specialized therapeutic indications, primarily for hormonal abnormalities, limit its market potential compared to drugs with broader therapeutic applications[1].

Adherence Issues

Patients often face difficulties adhering to gonadorelin therapy due to the need for precise dose schedules and delivery techniques. Ineffective adherence can impede market growth and affect treatment outcomes[1].

Ethical and Social Considerations

Ethical issues, such as the use of gonadorelin in off-label usage or assisted reproductive technologies, can influence patient and healthcare provider attitudes, potentially limiting market expansion in specific demographics or geographical areas[1].

Market Trends

Increasing Demand for Fertility Treatments

The global prevalence of infertility and hormonal abnormalities is driving the demand for effective treatments like gonadorelin acetate. Increased accessibility to fertility therapies and improvements in reproductive healthcare are key factors in this trend[4].

Advancements in Endocrinology and Reproductive Medicine

Ongoing research and clinical trials are optimizing treatment regimens and outcomes, further expanding the therapeutic applications of gonadorelin. Regulatory approvals for new formulations and expanded indications also contribute to market growth[4].

Demographic Factors

Delayed childbearing and other demographic changes support the increasing demand for gonadorelin-based treatments. Regulations promoting fertility treatments and the development of assisted reproductive technologies (ART) also encourage market expansion[4].

Financial Trajectory

The financial trajectory of the gonadorelin market is positive, with significant growth projected over the next several years. Here are some key financial highlights:

  • Market Size: The gonadorelin acetate market was valued at USD 100 billion in 2023 and is expected to reach USD 147.4 billion by 2031[4].
  • CAGR: The market is growing at a CAGR of 5% from 2024 to 2031[4].
  • Revenue Drivers: The market is driven by increasing demand for fertility treatments, advancements in healthcare infrastructure, and technological advancements in drug formulations and delivery systems[1][4].

Conclusion

The market for gonadorelin hydrochloride is poised for significant growth, driven by a combination of factors including improved diagnostic methods, advancements in healthcare infrastructure, and demographic changes. While the market faces challenges such as strict regulatory requirements and high treatment costs, ongoing research and clinical trials are expected to optimize treatment outcomes and expand the drug's therapeutic applications.

Key Takeaways

  • The gonadorelin acetate market is valued at USD 100 billion in 2023 and is expected to reach USD 147.4 billion by 2031.
  • The market is driven by increasing demand for fertility treatments and advancements in healthcare infrastructure.
  • Technological advancements in drug formulations and delivery systems are expected to increase the market potential.
  • Strict regulatory requirements and high treatment costs are significant challenges.
  • Ongoing research and clinical trials are optimizing treatment outcomes and expanding therapeutic applications.

FAQs

What are the primary therapeutic uses of gonadorelin?

Gonadorelin is used in the treatment of primary hypothalamic amenorrhea, hypogonadotropic hypogonadism, delayed puberty, cryptorchidism, and infertility. It is also used as a diagnostic agent to assess pituitary gland function[2].

How does gonadorelin work pharmacologically?

Gonadorelin acts as an agonist of the GnRH receptor, stimulating the pituitary gland to release FSH and LH, which in turn increase sex hormone production by the gonads[2].

What are the main drivers of the gonadorelin market growth?

The main drivers include growing knowledge and diagnosis of hormonal abnormalities, improvements in healthcare infrastructure, an aging population, and technological advancements in drug formulations and delivery systems[1].

What are the challenges facing the gonadorelin market?

Challenges include strict regulatory requirements, exorbitant treatment costs, side effects and safety issues, restricted therapeutic indications, adherence issues, and ethical and social considerations[1].

Which regions are key in the gonadorelin market?

Key regions include North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. Each region has its own market conditions and demand dynamics[1][4].

Who are the major players in the gonadorelin market?

Major players include Ferring, Xuchang Shangke Chemical, Bachem, Aspen Oss, Shenzhen JYMed Technology, Toronto Research Chemicals, LKT Laboratories, Hemmo Pharmaceutical, Angle BioPharma, and Merck[1].

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