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-seven 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

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	022517-001	Jun 21, 2018

International Patents for NOCDURNA

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2292903	ДЕСМОПРЕССИН В ЛЕКАРСТВЕННОЙ ФОРМЕ, ДИСПЕРГИРУЕМОЙ ВО РТУ (DESMOPRESSIN MEDICINAL FORMULATION DISPERSED IN MOUTH CAVITY)
Serbia	58224	DEZMOPRESIN ZA SMANJENJE NOĆNOG MOKRENJA (DESMOPRESSIN FOR REDUCING NOCTURNAL VOIDS)
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)
Denmark	2550007
Croatia	P20180774

Supplementary Protection Certificates for NOCDURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3225249	CA 2019 00023	Denmark		PRODUCT NAME: DESMOPRESSIN ELLER ET ACETATSALT DERAF; NAT. REG. NO/DATE: 55858, 55859 (DK) 20160526; FIRST REG. NO/DATE: BE BE497271, BE497280 20160504
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	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	LUC00015	Luxembourg		PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
2712622	201740002	Slovenia		PRODUCT NAME: DESMOPRESSINE OR ITS ACETATE SALT; NATIONAL AUTHORISATION NUMBER: H/16/02212/001-008; DATE OF NATIONAL AUTHORISATION: 20160818; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: BE497271,BE497280; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20160504; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: BE

NOCDURNA: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

NOCDURNA, a desmopressin acetate drug marketed by Ferring Pharmaceuticals, targets nocturia, a condition characterized by waking up more than once per night to urinate. The drug received U.S. Food and Drug Administration (FDA) approval in November 2018 for the treatment of nocturia due to nocturnal polyuria in men and women aged 65 years and older. Its mechanism of action involves enhancing the reabsorption of water in the kidneys, thereby reducing urine production during sleep.

What is NOCDURNA's Market Position?

NOCDURNA operates within the niche market of nocturia treatment. Its primary differentiator is its approval specifically for nocturia caused by nocturnal polyuria, a common subtype where the kidneys produce an excessive amount of urine at night. The drug is available in two strengths: 167 mcg and 333 mcg oral disintegrating tablets.

Key Market Segment Characteristics

• Patient Population: The target demographic is older adults (65+) experiencing sleep disruption due to nocturia. The prevalence of nocturia increases with age, driven by factors such as reduced vasopressin levels, prostate enlargement in men, and bladder changes.
• Competitive Landscape: While several treatment options exist for nocturia, NOCDURNA is one of the few FDA-approved medications specifically for this indication. Other approaches include lifestyle modifications (fluid restriction before bed, caffeine and alcohol reduction), behavioral therapies, and off-label use of other medications.
  • Existing Treatments: These include alpha-blockers for men with benign prostatic hyperplasia (BPH)-related nocturia, anticholinergics for overactive bladder symptoms contributing to nocturia, and beta-3 agonists. However, these treatments may not directly address nocturnal polyuria and can have systemic side effects.
  • Desmopressin Past: Desmopressin has a history of use for nocturia, but previous formulations or off-label uses faced challenges related to dosing, efficacy, and safety, particularly regarding the risk of hyponatremia (low sodium levels). NOCDURNA’s formulation and dosing are designed to mitigate these risks.
• Pricing and Reimbursement: As a prescription drug, NOCDURNA’s market access is dependent on payer coverage and patient co-pays. Pricing strategies and formulary placement significantly impact its uptake. The average wholesale price (AWP) for a 30-count bottle of NOCDURNA 167 mcg can range from $200 to $300, with the 333 mcg strength being comparably priced. Reimbursement levels vary across different insurance plans and Medicare/Medicaid programs.
• Physician Adoption: Prescribing patterns are influenced by clinical trial data, physician familiarity with desmopressin, and the perceived differentiation of NOCDURNA from prior desmopressin products. Education and awareness campaigns targeting urologists, geriatricians, and primary care physicians are crucial for driving adoption.

What are the Financial Projections for NOCDURNA?

Estimating the precise financial trajectory of a pharmaceutical product involves complex modeling of market penetration, prescription volume, pricing, and return on investment for research and development. Data on Ferring Pharmaceuticals’ private company financial performance is not publicly disclosed, making specific revenue projections for NOCDURNA challenging. However, market analysis and historical performance of similar niche drugs provide a basis for assessment.

Key Financial Considerations

• Launch and Early Adoption: Post-launch, initial sales are typically driven by early adopters and patients who have exhausted other treatment options or whose physicians are actively promoting the drug. The FDA approval in late 2018 and subsequent market introduction in 2019 marked the beginning of its commercial phase.
• Market Penetration Rate: The success of NOCDURNA hinges on its ability to capture a significant share of the diagnosed nocturia patient population experiencing nocturnal polyuria. This rate is influenced by factors such as physician prescribing habits, patient access, and the drug’s perceived value proposition compared to alternatives.
• Sales Growth Drivers:
  • Growing Elderly Population: The increasing demographic of individuals aged 65 and older naturally expands the potential patient pool for nocturia treatments.
  • Increased Diagnosis and Awareness: Greater patient and physician awareness of nocturia as a treatable condition, and specifically of NOCDURNA’s indication, can drive prescription growth.
  • Payer Coverage Expansion: Broader and more favorable reimbursement policies from insurance providers are critical for increasing patient affordability and access.
• Patent Expiry and Generic Competition: The patent landscape for NOCDURNA is a critical factor in its long-term financial outlook. Upon patent expiry, generic versions of desmopressin could enter the market, potentially leading to a significant decline in NOCDURNA’s revenue due to price competition. Understanding the exclusivity periods and potential for patent challenges is essential for investment decisions. Ferring Pharmaceuticals typically employs strategies to extend market exclusivity, such as developing new formulations or seeking additional indications.
• R&D Investment and Profitability: The profitability of NOCDURNA is contingent on the recoupment of its initial research, development, clinical trial, and marketing expenses. As a relatively specialized drug, the R&D investment may have been lower compared to blockbuster drugs, but market penetration remains key to achieving profitability.

Comparative Sales Performance (Hypothetical)

While precise figures are proprietary, industry analysts often use benchmarks. For niche drugs with a specific indication and an aging population target, initial annual sales might range from tens to hundreds of millions of dollars, with the potential for growth if market penetration is strong and competition remains limited. For context, other prescription drugs targeting sleep disorders or specific urological conditions can generate annual revenues in the low to mid-hundreds of millions, depending on their market share and pricing.

What are the Key Clinical and Regulatory Factors Influencing NOCDURNA?

The clinical profile and regulatory history of NOCDURNA are fundamental to its market viability and financial success.

Clinical Efficacy and Safety

• Efficacy: Clinical trials demonstrated that NOCDURNA significantly reduced the number of nighttime voids and increased the time to first void compared to placebo.
  • Trial Data: The Phase III trials (e.g., NCT02080683, NCT02079446) involved a significant number of patients (hundreds) and showed statistically significant reductions in nocturnal voids and improvements in sleep quality. For example, in one pivotal trial, patients treated with NOCDURNA experienced an average reduction of 1.1 voids per night compared to placebo.
• Safety Profile: The primary safety concern with desmopressin is the risk of hyponatremia, which can be severe and lead to seizures, coma, or death. NOCDURNA's development focused on mitigating this risk through specific dosing regimens and formulations designed for oral disintegration.
  • Hyponatremia Risk: The risk of hyponatremia is dose-dependent and also influenced by factors such as fluid intake. The recommended dosing for NOCDURNA involves starting with a specific strength and adjusting as needed, with strict guidance on fluid intake.
  • Black Box Warning: The U.S. Prescribing Information for NOCDURNA includes a boxed warning regarding the risk of hyponatremia. This warning highlights the importance of careful patient selection, monitoring, and adherence to dosing and fluid restrictions.
• Adverse Events: Common adverse events reported in clinical trials include headache, dizziness, nausea, and dry mouth. Serious adverse events, while rare, are primarily linked to hyponatremia.

Regulatory Landscape

• FDA Approval: U.S. FDA approval in November 2018 followed the submission of New Drug Applications (NDAs) based on robust clinical trial data.
• European Medicines Agency (EMA) Approval: NOCDURNA also received EMA approval, marketed as Minirin Melt in some regions, for the treatment of nocturia.
• Labeling Requirements: The drug’s labeling, including the boxed warning, is a critical regulatory component that influences prescribing practices and patient education.
• Post-Marketing Surveillance: Like all approved drugs, NOCDURNA is subject to ongoing post-marketing surveillance by regulatory authorities to monitor its safety and effectiveness in real-world use. Any emerging safety signals could lead to label changes or further regulatory actions.
• Patent Protection: Exclusivity periods granted by regulatory bodies (e.g., Hatch-Waxman Act in the U.S.) provide a period of market protection from generic competition. These periods are crucial for pharmaceutical companies to recoup R&D investments.

What are the Future Market Opportunities and Challenges?

The future trajectory of NOCDURNA will be shaped by its ability to expand its market presence and navigate evolving competitive and regulatory environments.

Market Opportunities

• Expanded Patient Identification: As awareness of nocturia as a treatable condition grows, more patients may seek medical advice, leading to increased diagnosis and potential prescriptions for NOCDURNA.
• Geographic Expansion: Successful market entry and uptake in countries beyond the U.S. and Europe could significantly boost sales.
• Combination Therapies: Exploring potential benefits of NOCDURNA in combination with other treatments for nocturia or associated conditions like BPH could open new avenues.
• New Indications: Research into the efficacy of desmopressin, potentially through NOCDURNA’s formulation, for other nocturia-related conditions or related physiological challenges could lead to label expansions.

Market Challenges

• Generic Competition: The most significant future challenge will be the eventual loss of market exclusivity due to generic desmopressin products. The timing and impact of this competition are critical to monitor.
• Reimbursement Pressures: Healthcare systems worldwide are increasingly focused on cost containment, which can lead to payer restrictions, increased prior authorization requirements, and downward pressure on drug prices.
• Physician Inertia and Prescribing Habits: Changing established prescribing habits requires sustained educational efforts and compelling clinical evidence demonstrating clear advantages over existing or off-label treatments.
• Patient Adherence: The need for careful fluid management and adherence to dosing schedules can be a barrier to consistent use for some patients.
• Emerging Therapies: The development of novel non-pharmacological or pharmacological treatments for nocturia could disrupt the market.

Key Takeaways

NOCDURNA is an FDA-approved medication targeting nocturia due to nocturnal polyuria in older adults. Its market position is defined by its specific indication and the challenges of treating a common but often undertreated condition in an aging population. Financial projections are private but hinge on market penetration, reimbursement, and the eventual impact of generic competition. Clinical efficacy and a carefully managed safety profile, particularly regarding hyponatremia, are central to its value proposition, underscored by a boxed warning. Future opportunities lie in expanded patient identification and geographic reach, while challenges include generic erosion, reimbursement pressures, and physician adoption.

Frequently Asked Questions

What is the primary mechanism of action for NOCDURNA?

NOCDURNA contains desmopressin acetate, which enhances water reabsorption in the kidneys, reducing urine production during nighttime hours.

What is the main safety concern associated with NOCDURNA?

The primary safety concern is hyponatremia, a condition characterized by abnormally low sodium levels in the blood, which can be serious. This risk is highlighted by a boxed warning in the drug's prescribing information.

When was NOCDURNA first approved by the U.S. FDA?

NOCDURNA received U.S. FDA approval in November 2018.

What patient population is NOCDURNA indicated for?

NOCDURNA is indicated for the treatment of nocturia due to nocturnal polyuria in men and women aged 65 years and older.

What is the expected impact of patent expiry on NOCDURNA's market?

Upon patent expiry, the introduction of generic desmopressin products is anticipated, which will likely lead to increased price competition and a potential decline in NOCDURNA's market share and revenue.

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Citations

[1] U.S. Food & Drug Administration. (2018, November 27). FDA approves NOCDURNA (desmopressin acetate) tablets for the treatment of nocturia due to nocturnal polyuria in men and women aged 65 years and older. Press Release. [2] Ferring Pharmaceuticals. (n.d.). NOCDURNA® (desmopressin acetate) prescribing information. Retrieved from https://www.ferring.com/ (Note: Specific link to prescribing information often requires professional portal access or direct search). [3] National Institute on Aging. (2021, October 19). Bladder problems. Retrieved from https://www.nia.nih.gov/health/bladder-problems [4] ClinicalTrials.gov. (n.d.). Search results for desmopressin acetate and nocturia. Retrieved from https://clinicaltrials.gov/ [5] Wolters Kluwer Health. (2023). Nocdurna (desmopressin acetate). In Physicians' Desk Reference. [6] European Medicines Agency. (n.d.). Minirin Melt. Retrieved from https://www.ema.europa.eu/