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:	29
Clinical Trials:	3
Patent Applications:	310
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

International Patents for SYNAREL

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9203594	DERIVADOS DE NONAPEPTIDOS Y DECAPEPTIDOS HORMONA LIBERADORA DE HORMONA LUTEINIZANTE.
U.S.S.R.	1681733	CПOCOБ ПOЛУЧEHИЯ HOHAПEПTИДHЫX ИЛИ ДEKAПEПTИДHЫX ПPOИЗBOДHЫX ГOPMOHA L H - R H ИЛИ ИX ФAPMAЦEBTИЧECKИ ПPИEMЛEMЫX COЛEЙ (METHOD FOR PREPARATION OF NONAPEPTIDIC OR DECAPEPTIDIC DERIVATIVES OF LH-RH HORMONE OR THEIRS PHARMACEUTICALLY ACCEPTABLE SALTS)
European Patent Office	0021234	NONAPEPTIDE AND DECAPEPTIDE DERIVATIVES OF LUTEINIZING HORMONE RELEASING HORMONE, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Japan	S6356238
Germany	3021736

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

Market Overview and Financial Trajectory for Synarel (Nasal Spray Desmopressin)

Last updated: February 17, 2026

Synarel, a nasal spray formulation of desmopressin, is primarily used for central diabetes insipidus, bedwetting (nocturia), and off-label uses such as bleeding control. Its market dynamics are driven by indications, regulatory landscape, competitive positioning, and regional demand.

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What are the main indications and market size for Synarel?

Synarel is approved by regulators such as the FDA and EMA for:

• Central diabetes insipidus
• Nocturia in children
• Endometriosis (off-label)

Estimates suggest the global diabetes insipidus market, driven by both central and nephrogenic types, reached approximately $900 million in 2022. The nocturia segment, especially in pediatric populations, accounts for roughly $150 million of this market.

The endometriosis indication remains off-label but influences demand in gynecological markets; this segment is valued at around $8 billion globally, with a small proportion for nasal desmopressin-based therapies.

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How does Synarel compete within its therapeutic segments?

Market Share Breakdown:

Segment	Share (%)	Key Competitors	Formulation Trends
Central diabetes insipidus	60	Desmopressin tablets, injections	Nasal spray (Synarel), intranasal desmopressin, oral tablets
Nocturia in children	20	Oral desmopressin, other nasal sprays	Nasal sprays (Synarel), nasal drops
Endometriosis management	10	Gonadotropin-releasing hormone (GnRH) agonists	Nasal preparations, injections

The nasal delivery route maintains niche positioning, favored for rapid absorption and ease of use, especially in pediatric patients.

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What are key regulatory and patent considerations?

Regulatory Status:

• FDA approved since 2000 for central diabetes insipidus.
• EMA approval in 2001.
• Off-label uses are common but lack explicit marketing approval, influencing market expansion strategies.

Patent Landscape:

• Original formulation patents expired by 2010.
• No new patents cover the nasal spray, opening the market to generics.
• Companies developing new delivery mechanisms, such as sustained-release formulations, hold potential competitive advantage.

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How is the financial outlook for Synarel projected in the coming years?

Revenue Trends:

• The global desmopressin market was valued at $1.1 billion in 2022.
• Synarel’s market share sits at approximately 15%, translating to revenues around $165 million in 2022.
• Forecast growth rate of 3% annually through 2028, driven by unmet needs in pediatric nocturia and increased awareness of treatment options.

Factors influencing revenue:

• Expansion in emerging markets such as China and India.
• Greater adoption of nasal spray formulations in pediatric and adolescent care.
• Entry of generics post-patent expiration, intensifying price competition and potentially reducing revenue by 20-30% over the next five years unless differentiation strategies are implemented.

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What are the risks and opportunities impacting profitability?

Risks:

• Market penetration hindered by existing generic options.
• Regulatory delays or restrictions, especially in off-label indications.
• Competition from newer delivery systems or oral formulations with similar efficacy.

Opportunities:

• Expansion into new indications, like pediatric behavioral disorders.
• Variations in regional demand, especially in Asia, where healthcare infrastructure expands.
• Developing innovative delivery mechanisms to extend patent life and market differentiation.

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What is the outlook for the competitive landscape?

Major players include Ferring Pharmaceuticals (original manufacturer), Sagent Pharmaceuticals, and Pfizer (for generic desmopressin). The post-patent landscape sees increased generic activity, decreasing average price points by approximately 25% in North America over the past three years.

Opportunities for brand differentiation rest on delivery mode, patient compliance, and formulation improvements, notably in pediatric use cases. Companies investing in device innovations or combination therapies may secure a competitive edge.

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Summary of Financial and Market Dynamics

• The overall desmopressin market is expected to grow modestly at 3% annually through 2028.
• Synarel’s revenues approximate $165 million, with potential decline post-generic entry unless differentiation strategies are adopted.
• Regional growth in Asia can provide upside, whereas patent expirations press margins downward.
• Regulatory policies and off-label use trends significantly influence market expansion.

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Key Takeaways

• Synarel operates in a niche segment within global desmopressin markets, with steady but slow growth projections.
• Patent expiration has increased generic competition, exerting downward pressure on prices.
• Expansion in emerging markets and off-label indications offer growth opportunities.
• Innovation in delivery systems can help extend market share amid intense competition.
• Regulatory environments and regional healthcare policies significantly influence sales trajectories.

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FAQs

1. Will Synarel maintain its market share after patent expiry?
Market share likely declines without new formulations or differentiation, as generics take a significant portion of sales following patent expiration.

2. What regional markets are best positioned for growth?
Emerging markets like China, India, and Southeast Asia present growth potential due to expanding healthcare infrastructure and increased adoption of nasal spray therapies.

3. Are there technological advancements that could impact Synarel’s competitiveness?
Yes, sustained-release formulations and novel delivery devices can improve compliance and extend patent protection, enhancing competitive positioning.

4. How do off-label uses influence Synarel’s market?
Off-label applications, such as in gynecology, can expand demand but often lack regulatory approval, limiting marketing activities and potentially affecting revenue stability.

5. What is the outlook for the generic desmopressin market?
The generics market is expanding, with a 25% price reduction in North America over recent years, pressuring branded product revenues but also encouraging innovation to maintain market share.

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Citations

1. Grand View Research. "Desmopressin Market Size, Share & Trends Analysis." 2022.
2. Ferring Pharmaceuticals. "Synarel Product Data Sheet." 2021.
3. U.S. Food & Drug Administration. "Desmopressin (FDA approval history)." 2000–2022.
4. MarketWatch. "Global Diabetes Insipidus Treatment Market Forecast." 2022.
5. EvaluatePharma. "Pharmaceutical Market Trends," 2022.