NAFARELIN ACETATE - Generic Drug Details

What are the generic sources for nafarelin acetate and what is the scope of patent protection?

Nafarelin acetate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for nafarelin acetate. One supplier is listed for this compound.

Summary for NAFARELIN ACETATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Patent Applications:	6,972
What excipients (inactive ingredients) are in NAFARELIN ACETATE?	NAFARELIN ACETATE excipients list
DailyMed Link:	NAFARELIN ACETATE at DailyMed

Pharmacology for NAFARELIN ACETATE

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for NAFARELIN ACETATE

Fertility Agents, Female

Anatomical Therapeutic Chemical (ATC) Classes for NAFARELIN ACETATE

H01CA	Gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for NAFARELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	SYNAREL	nafarelin acetate	SPRAY, METERED;NASAL	019886-001	Feb 13, 1990		RX	Yes	Yes

Expired US Patents for NAFARELIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SYNAREL	nafarelin acetate	SPRAY, METERED;NASAL	019886-001	Feb 13, 1990	4,234,571

NAFARELIN ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nafarelin Acetate

Introduction

Nafarelin acetate, a synthetic analog of gonadotropin-releasing hormone (GnRH), is used primarily for the treatment of central precocious puberty (CPP) and endometriosis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global market for nafarelin acetate has been experiencing steady growth. As of 2023, the market size was valued at approximately USD 300 million. Projections indicate that this market is expected to reach around USD 480 million by 2032, reflecting a significant increase in demand and usage over the next decade[1][4].

Key Drivers of Growth

Several factors are driving the growth of the nafarelin acetate market:

Increasing Prevalence of Central Precocious Puberty

The rising incidence of CPP, particularly in children, is a major driver. Nafarelin acetate is a preferred treatment for this condition due to its effectiveness in delaying puberty until a more appropriate age[5].

Growing Awareness and Diagnosis of Endometriosis

Endometriosis, a painful condition affecting many women, is another key area where nafarelin acetate is prescribed. Increased awareness and better diagnostic techniques are leading to more diagnoses and subsequent treatments, contributing to market growth[5].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing countries, are making it easier for patients to access advanced treatments like nafarelin acetate. This expanded access is driving market expansion[4].

Market Dynamics

The market for nafarelin acetate is influenced by several dynamics:

Competitive Landscape

The market is relatively niche, with a few key players such as Pfizer, which manufactures SYNAREL (nafarelin acetate) nasal solution. The competitive landscape is characterized by a limited number of manufacturers, which can lead to stable market positions for existing players[2].

Regulatory Environment

Regulatory approvals and compliance are crucial. Nafarelin acetate has undergone extensive clinical trials and has been approved for use in various regions. However, ongoing regulatory scrutiny, especially regarding long-term safety and efficacy, can impact market dynamics[2].

Patient Compliance and Counseling

Patient compliance is a significant factor. Irregular or incomplete daily doses can lead to stimulation of the pituitary-gonadal axis, reducing the effectiveness of the treatment. Therefore, adequate counseling and patient education are essential for optimal outcomes[5].

Financial Performance and Projections

The financial performance of nafarelin acetate is closely tied to its market size and growth.

Revenue Streams

The primary revenue streams come from the sale of nafarelin acetate nasal sprays, which are prescribed for both CPP and endometriosis. The revenue is expected to increase as the market expands, driven by growing demand and increased access to healthcare services[1][4].

Cost and Pricing

The cost of nafarelin acetate can vary based on the region, healthcare system, and insurance coverage. Generally, the pricing is competitive within the GnRH agonist market. However, the cost-effectiveness of the treatment, especially in the long term, is a factor that influences market dynamics and financial performance[5].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of nafarelin acetate is crucial for its financial trajectory. The drug is rapidly absorbed into the systemic circulation after intranasal administration, with peak serum concentrations achieved within 10-45 minutes. Its bioavailability and serum half-life influence dosing regimens and treatment efficacy, which in turn affect market acceptance and financial performance[2].

Side Effects and Safety Concerns

While nafarelin acetate is generally well-tolerated, it can cause several side effects, including bone mineral density decrease, depression, and temporary worsening of symptoms. These safety concerns can impact patient compliance and, consequently, the financial performance of the drug. Continuous monitoring and addressing these concerns through clinical trials and patient education are essential[5].

Geographical Distribution

The market for nafarelin acetate is distributed across various regions, with developed countries currently being the largest markets. However, emerging markets are expected to contribute significantly to the growth due to improving healthcare infrastructure and increasing awareness of treatable conditions like CPP and endometriosis[4].

Future Outlook

The future outlook for nafarelin acetate is positive, driven by increasing demand, advancements in healthcare, and the expanding reach of diagnostic and treatment services. However, the market will need to navigate regulatory challenges, ensure patient compliance, and address safety concerns to maintain its growth trajectory.

Key Takeaways

• The global nafarelin acetate market is projected to grow from USD 300 million in 2023 to USD 480 million by 2032.
• Key drivers include the increasing prevalence of CPP and endometriosis, along with advancements in healthcare infrastructure.
• The market is influenced by a competitive landscape, regulatory environment, and patient compliance.
• Financial performance is tied to revenue streams from sales, cost and pricing strategies, and pharmacokinetic properties.
• Addressing side effects and safety concerns is crucial for maintaining market growth.

Frequently Asked Questions (FAQs)

Q: What is nafarelin acetate used for? A: Nafarelin acetate is used for the treatment of central precocious puberty (CPP) and endometriosis.

Q: How is nafarelin acetate administered? A: Nafarelin acetate is administered as a nasal spray.

Q: What are the potential side effects of nafarelin acetate? A: Potential side effects include bone mineral density decrease, depression, and temporary worsening of symptoms.

Q: Is nafarelin acetate safe for use during pregnancy? A: No, nafarelin acetate should not be used during pregnancy as it can harm the unborn baby.

Q: How does nafarelin acetate affect bone growth in children? A: Nafarelin acetate can slow down bone growth in children, which can be beneficial for those experiencing early puberty, allowing for more normal growth patterns.

Sources:

1. Dataintelo - Nafarelin Acetate Market Research Report 2032
2. Pfizer - SYNAREL (nafarelin acetate) Nasal Solution
3. Mayo Clinic - Nafarelin (nasal route)
4. Market Research Reports - Global Nafarelin Acetate Market 2023 by Manufacturers, Regions, Type, and Application Forecast 2029