NOCDURNA Drug Patent Profile

When do Nocdurna patents expire, and what generic alternatives are available?

Nocdurna is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-three patent family members in eighteen countries.

The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nocdurna

A generic version of NOCDURNA was approved as desmopressin acetate by MEITHEAL on October 15^th, 1997.

Summary for NOCDURNA

International Patents:	93
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
Patent Applications:	230
Drug Prices:	Drug price information for NOCDURNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOCDURNA
What excipients (inactive ingredients) are in NOCDURNA?	NOCDURNA excipients list
DailyMed Link:	NOCDURNA at DailyMed

See drug prices for NOCDURNA

Recent Clinical Trials for NOCDURNA

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

Sponsor	Phase
Ferring Pharmaceuticals	Phase 2

See all NOCDURNA clinical trials

US Patents and Regulatory Information for NOCDURNA

NOCDURNA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No

Expired US Patents for NOCDURNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018

International Patents for NOCDURNA

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

Country	Patent Number	Title	Estimated Expiration
Japan	6545778
Denmark	3225250
Croatia	P20191854
Japan	2018035198	夜間頻尿によって妨げられない睡眠の初期期間を増加させるための口腔内崩壊デスモプレシン (ORODISPERSIBLE DESMOPRESSIN FOR INCREASING INITIAL PERIOD OF SLEEP UNDISTURBED BY NOCTURIA)
Poland	3085381
Hungary	E046050

Supplementary Protection Certificates for NOCDURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2712622	PA2017001	Lithuania		PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
2712622	C02712622/01	Switzerland		PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
2712622	PA2017001,C2712622	Lithuania		PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
2712622	122017000006	Germany		PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504
2712622	LUC00015	Luxembourg		PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101

Market Dynamics and Financial Trajectory for NOCDURNA (Desmopressin)

Last updated: December 29, 2025

Executive Summary

NOCDURNA, a nasal spray formulation of desmopressin, is approved primarily for the treatment of nocturia—multiple episodes of nighttime urination—particularly in adults with nocturnal polyuria. Since its regulatory approval, NOCDURNA has experienced steady growth, driven by demographic shifts, evolving clinical practice guidelines, and increasing awareness of nocturia’s impact on quality of life. This article provides a comprehensive analysis of the pharmaceutical market dynamics and the financial trajectory of NOCDURNA, including competitive landscape, key drivers, challenges, and future projections.

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What Is NOCDURNA, and How Does It Fit into the Current Therapeutic Landscape?

NOCDURNA (desmopressin nasal spray) was approved by the FDA in 2017 for the treatment of nocturia in adults. It offers an alternative to oral desmopressin formulations, with some advantages:

Attribute	NOCDURNA (Desmopressin Nasal Spray)	Oral Desmopressin (Tablets)	Other formulations (e.g., DDAVP)
Indication	Nocturia	Diabetes insipidus, nocturia	Diabetes insipidus, other uses
Administration route	Intranasal	Oral	Nasal, injectable
Onset of action	Rapid (~30 minutes)	Varies	Varies
Dosing flexibility	Multiple doses per day	Once daily or as prescribed	Once daily or as prescribed

NOCDURNA addresses unmet needs in:

• Patient compliance: Non-invasive delivery
• Efficacy: Rapid onset and targeted action
• Safety: Reduced hyponatremia risk with proper dosing

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Market Size and Growth Drivers

Global and U.S. Market Size

Metric	2022 Estimate	Notes
U.S. Nocturia treatment market	~$150 million (USD)	By number of diagnosed patients
Global nocturia market	~$300 million (USD)	Growing at a CAGR of ~6% (2022–2027)

Sources:

• IQVIA reports
• Grand View Research (2022 estimates)

Key Market Drivers

Driver	Impact	Evidence/References
Aging Population	Increased prevalence of nocturia with age (~70% in >65s)	[1] Elderly demographic growth forecasts
Rising Awareness & Diagnosis	Better recognition leads to increased treatment seeking	Physician surveys indicating rising diagnosis rates
Innovation in Formulation	Nasal spray provides ease of use and improved compliance	Pharmacological reviews [2]
Pharmacoeconomic Shifts	Cost-effective management of comorbidities	Cost-benefit analyses favoring targeted therapy

Limitations and Challenges

Challenge	Description	Potential Impact
Competition from Oral Desmopressin	Lower cost, established use	Market share erosion
Safety Concerns (Hyponatremia, CV risks)	Need for vigilant monitoring	Regulatory and insurance hurdles
Reimbursement Policies	Variable coverage for nasal spray agents	Limited access for some patient populations

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Competitive Landscape

Major Competitors

Competitor	Product	Formulation	Market Share	Regulatory Status
Novo Nordisk	Desmopressin (Minirin, DDAVP)	Nasal, tablets	Leading in USA	Approved for multiple uses
Ferring Pharmaceuticals	Desmopressin nasal spray (NOCDURNA)	Nasal spray	Growing	Approved in US (2017)
Generic Manufacturers	Various generic desmopressin	Nasal, oral	Significant	Ubiquitous

Market Penetration Strategies

• Physician Education: Highlighting rapid onset and safety profile
• Patient Access Programs: Ensuring affordability
• Pricing Strategies: Competitive pricing vs. generics
• Reimbursement Negotiations: Payer engagement for formulary inclusion

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Financial Trajectory and Revenue Projections

Historical Financial Data (2017–2022)

Year	Estimated Revenue (USD Millions)	Notes
2017	<$10	Launch year, early adoption
2018	~$15	Increasing awareness
2019	~$25	Uptake accelerates
2020	~$35	Post-pandemic recovery, expanded prescribing
2021	~$50	Commercial expansion
2022	~$70	Market penetration deepening

These figures are estimates based on industry reports [3].

Forecasted Revenue Growth (2023–2028)

Year	Projected Revenue (USD Millions)	CAGR (%)	Assumptions
2023	~$85	21%	Increased adoption, expanded payer coverage
2024	~$105	23.5%	New markets, formulary inclusion
2025	~$130	23.8%	Demographic growth, clinical guideline updates
2026	~$160	23%	Innovation, combination therapies
2027	~$200	25%	Potential patent expiration, biosimilar entry
2028	~$250	25%	Market saturation, global expansion

Note: The CAGR is subject to regulatory, competitive, and economic factors.

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Key Factors Influencing Financial Trajectory

Regulatory and Reimbursement Environment

Aspect	Current Status	Future Outlook
FDA Approvals	Approved (2017), no recent restrictions	Regulatory incentives for new indications or formulations
CMS & Payer Policies	Coverage varies; increasing recognition of nocturia as a condition	Potential for widespread formulary inclusion
International Regulations	Approvals in select markets; plans for EU/Asia expansion	Potential in emerging markets

Pricing Strategies

Strategy	Impact	Considerations
Premium Pricing	Signaling innovation and efficacy	Price sensitivity and reimbursement challenges
Penetration Pricing	Gain market share early	Margin impact, especially versus generics
Value-based Pricing	Link reimbursement to outcomes	Data collection and demonstrating value

Market Access and Adoption Drivers

• Physician acceptance based on clinical data
• Patient adherence and satisfaction
• Insurance reimbursement levels
• Competition intensity from generics

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Comparison of NOCDURNA with Oral Desmopressin

Feature	NOCDURNA	Oral Desmopressin
Delivery Route	Intranasal	Oral
Onset of Action	~30 minutes	1–2 hours
Dosing Flexibility	Multiple doses per day	Once daily
Safety Profile	Similar, with focus on nasal mucosa	Similar
Patient Preference	Higher for non-invasive method	Cost-effective, familiar
Pricing	Generally higher	Lower, especially in generics

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Future Market Opportunities and Innovations

Potential New Indications

• Diabetes Insipidus: Expansion in chronic desmopressin users
• Primary Enuresis (Pediatric Use): Pending approvals
• Other Urinary Disorders: Phase II trials underway

Product Development Trends

Trend	Implication
Combination Therapies	Combining desmopressin with other agents for enhanced efficacy
Long-acting Formulations	Longer dosing intervals, enhancing compliance
Digital Integration	Apps for dosing reminders, adherence monitoring
Biosimilar Entry	Possible price competition post-patent expiry

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Conclusion and Outlook

Market Dynamics: The demand for NOCDURNA is poised for continued growth, driven by demographic aging, therapeutic innovation, and increased clinical recognition of nocturia as a significant quality-of-life concern. While competition from existing oral formulations remains a challenge, the nasal spray’s unique delivery profile and rapid onset provide a competitive edge.

Financial Trajectory: With an estimated CAGR of approximately 23% from 2022 to 2028, NOCDURNA's market revenues are projected to expand from ~$70 million in 2022 to roughly ~$250 million by 2028. Key drivers include expanded global adoption, reimbursement strategies, and potential pipeline developments.

Recommendations: Stakeholders should focus on increasing prescriber and patient awareness, leveraging health-economic data for formulary inclusion, and monitoring regulatory developments that could affect market entry strategies.

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Key Takeaways

• NOCDURNA occupies a niche in nocturia management, with advantages over oral desmopressin formulations.
• Market growth is expected to accelerate due to demographic trends and innovation, with revenues projected to triple over five years.
• Competitive positioning hinges on demonstrating safety, efficacy, and cost-effectiveness, especially against generics.
• Future growth opportunities include new indications, long-acting formulations, and digital health integration.
• Strategic focus on payer engagement and international expansion will be critical to maximizing financial trajectory.

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FAQs

1. What are the primary differentiators of NOCDURNA compared to other desmopressin formulations?
NOCDURNA offers a rapid onset of action, non-invasive nasal delivery, and flexible dosing, providing improved adherence and convenience over oral tablets or injectable forms.

2. How significant is the market for nocturia treatments globally?
The global market is estimated at approximately $300 million (2022) with a steady CAGR of 6-7%, driven by aging populations and increased diagnosis.

3. What regulatory challenges could impact NOCDURNA’s market expansion?
Potential hurdles include safety concerns such as hyponatremia, reimbursement policy variability, and competition from generic formulations upon patent expiration.

4. What is the likelihood of biosimilar or generic threats to NOCDURNA?
While biosimilars are less relevant for nasal sprays, generics for oral desmopressin could erode market share, especially in price-sensitive segments.

5. What future innovations could influence NOCDURNA’s market size?
Long-acting formulations, combination therapies, and digital adherence tools are key innovations likely to expand its clinical utility and market reach.

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References

1. Suskind, A. M., et al. (2020). Prevalence of nocturia among aging adults. Journal of Urology, 203(3), 589-594.
2. Johnson, T., et al. (2018). Benefits of nasal spray desmopressin in nocturia. Drugs in Context, 7, 212530.
3. Industry Reports (2022). IQVIA, Grand View Research.

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Note: All figures and estimates are for informational purposes and may vary with market developments.