SYNAREL Drug Patent Profile

Which patents cover Synarel, and what generic alternatives are available?

Synarel is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in SYNAREL is nafarelin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nafarelin acetate profile page.

Summary for SYNAREL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	3
Patent Applications:	405
Drug Prices:	Drug price information for SYNAREL
What excipients (inactive ingredients) are in SYNAREL?	SYNAREL excipients list
DailyMed Link:	SYNAREL at DailyMed

See drug prices for SYNAREL

Recent Clinical Trials for SYNAREL

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

Sponsor	Phase
University of California, San Diego	Early Phase 1
Shaare Zedek Medical Center	N/A
New Hope Fertility Center	N/A

See all SYNAREL clinical trials

Pharmacology for SYNAREL

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

US Patents and Regulatory Information for SYNAREL

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 SYNAREL

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

International Patents for SYNAREL

See the table below for patents covering SYNAREL around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	79384
Denmark	248880
Canada	1157851	DERIVES NONAPEPTIDES ET DECAPEPTIDES DE L'HORMONE DE LIBERATION DE LA LUTEINOSTIMULINE (NONAPEPTIDE AND DECAPEPTIDE DERIVATIVES OF LUTEINIZING HORMONE RELEASING HORMONE)
Finland	72527
Japan	S6425794	PRODUCTION OF NOVEL PEPTIDE DERIVATIVE OF LUTEINIZING HORMONE DISCHARGE HORMONE
United Kingdom	2054603	NONAPEPTIDE AND DECAPEPTIDE DERIVATIVES OF LUTEINIZING HORMONE RELEASING HORMONE

Supplementary Protection Certificates for SYNAREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0021234	SPC/GB93/056	United Kingdom		SPC/GB93/056, EXPIRES: 20050609
0021234	93C0049	Belgium		PRODUCT NAME: NAFARELIN. ACETAT; NAT. REG.: 194 IS 46 F 11 19920616; FIRST REG.: DK D.SP.NR. 8291 19900628

SYNAREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SYNAREL (Nafarelin)

Introduction

Nafarelin, marketed under the brand name Synarel, is a synthetic decapeptide analog of the naturally occurring gonadotropin-releasing hormone (GnRH). It is used in the treatment of various conditions, including endometriosis, precocious puberty, and prostate cancer. Here, we will delve into the market dynamics and financial trajectory of nafarelin.

Market Size and Growth

The global nafarelin market has been experiencing steady growth. As of 2023, the market size was valued at approximately USD 320 million. It is projected to reach USD 460 million by 2032, growing at a compound annual growth rate (CAGR) of around 4-5% during this period[4].

Treatment Applications

Nafarelin is primarily used in the treatment of:

• Endometriosis: It helps in reducing the symptoms by suppressing the production of estrogen.
• Precocious Puberty: It delays early onset puberty in children.
• Prostate Cancer: It is used to manage the symptoms of prostate cancer by reducing testosterone levels.

Market Segments

The market for nafarelin can be segmented based on treatment type, drug class, and route of administration.

Treatment Type

• Pain Management: For endometriosis, nafarelin is used to manage pain and reduce the size of endometrial lesions.
• Hormone Therapy: It is a form of GnRH agonist therapy, which is crucial in treating conditions like prostate cancer and precocious puberty.

Drug Class

• Gonadotropin Releasing Hormone (GnRH) Agonists: Nafarelin falls under this category, which includes other GnRH agonists used for similar therapeutic purposes.

Route of Administration

• Nasal Spray: Nafarelin is commonly administered via a nasal spray, which is convenient and effective for patients.

Distribution Channels

The distribution of nafarelin is primarily through:

• Retail Pharmacies: This segment dominates the market due to the high presence of over-the-counter and prescription drugs. Patients often receive nafarelin prescriptions that are filled at retail pharmacies[1].
• Hospital Pharmacies: Although less common, hospital pharmacies also play a role, especially in cases where patients require close monitoring or are undergoing other treatments.

Regional Outlook

The market for nafarelin is spread across various regions, with significant presence in:

• North America: This region accounts for a substantial share due to the high prevalence of endometriosis and other conditions treated with nafarelin. For instance, in the U.S., a significant number of women are affected by endometriosis, driving the demand for nafarelin[1].
• Europe: Countries like Germany, the U.K., and France also contribute to the market growth due to increasing awareness and healthcare expenditure.
• Asia Pacific: This region is expected to witness significant growth due to the rising number of disease cases and strategic initiatives by market players for regional expansion.

Competitive Landscape

The market for nafarelin is competitive, with several key players involved:

• Pfizer, Inc.: Although not exclusively a nafarelin manufacturer, Pfizer is a major player in the broader pharmaceutical market and has interests in similar therapeutic areas.
• Other Pharmaceutical Companies: Companies specializing in hormone therapies and GnRH agonists also compete in this market.

Financial Trajectory

Revenue Projections

The revenue from nafarelin is expected to grow steadily, reaching USD 460 million by 2032. This growth is driven by increasing demand for effective treatments for endometriosis and other conditions[4].

Research and Development

Investment in research and development is crucial for maintaining market position. However, the costs associated with R&D are significant. For example, the average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years[3].

Challenges and Opportunities

• Regulatory Hurdles: Nafarelin, like other pharmaceuticals, faces stringent regulatory requirements, which can impact its market trajectory.
• Generic and Biosimilar Competition: The introduction of generic or biosimilar versions can significantly reduce sales for the original brand-name drug, impacting revenue[3].

Key Takeaways

• Growing Market: The nafarelin market is expected to grow at a CAGR of around 4-5% until 2032.
• Diverse Applications: Nafarelin is used in treating various conditions, including endometriosis, precocious puberty, and prostate cancer.
• Strong Distribution Network: Retail pharmacies dominate the distribution channels, with hospital pharmacies also playing a role.
• Regional Growth: North America and Europe are significant markets, with Asia Pacific expected to grow rapidly.
• Competitive Landscape: The market is competitive, with major pharmaceutical companies involved.

FAQs

1. What is nafarelin used for? Nafarelin is used in the treatment of endometriosis, precocious puberty, and prostate cancer.

2. How is nafarelin administered? Nafarelin is commonly administered via a nasal spray.

3. What is the projected market size for nafarelin by 2032? The global nafarelin market is projected to reach USD 460 million by 2032.

4. Which regions dominate the nafarelin market? North America and Europe are the dominant regions, with Asia Pacific expected to grow significantly.

5. What are the major challenges facing the nafarelin market? Regulatory hurdles, generic and biosimilar competition, and high R&D costs are significant challenges.

Sources

1. Grand View Research - Endometriosis Treatment Market Size & Trends Report, 2030
2. Fintel - SNG / Synairgen plc (AIM) - Forecast, Price Target, Estimates
3. DrugBank Blog - Investment Trends in Pharmaceutical Research
4. Dataintelo - Nafarelin Market Research Report 2032
5. Synairgen - Results for the year ended 31 December 2023