NOCTIVA Drug Patent Profile

When do Noctiva patents expire, and when can generic versions of Noctiva launch?

Noctiva is a drug marketed by Acerus Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-four patent family members in nineteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Noctiva

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

Summary for NOCTIVA

International Patents:	74
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	230
Drug Prices:	Drug price information for NOCTIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOCTIVA
DailyMed Link:	NOCTIVA at DailyMed

See drug prices for NOCTIVA

US Patents and Regulatory Information for NOCTIVA

NOCTIVA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No			Y
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No			Y

Expired US Patents for NOCTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017

International Patents for NOCTIVA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20120046176	SAFE DESMOPRESSIN ADMINISTRATION
Poland	2442821
Russian Federation	2015144851	БЕЗОПАСНОЕ ПРИМЕНЕНИЕ ДЕСМОПРЕССИНА
Denmark	2381923

Supplementary Protection Certificates for NOCTIVA

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	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
3225249	2019C/520	Belgium		PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
2712622	C02712622/01	Switzerland		PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018

Market Dynamics and Financial Trajectory for NOCTIVA (Desmopressin Nasal Spray)

Last updated: July 27, 2025

Introduction

NOCTIVA (desmopressin nasal spray) has carved a niche within the therapeutic landscape, targeted primarily at managing nocturnal polyuria (NP), a condition characterized by excessive urine production during the night. Since its US approval in 2017, NOCTIVA's market trajectory has been shaped by evolving patient needs, competitive pressures, regulatory considerations, and manufacturing challenges. This article analyzes the shifting market dynamics and forecasts the drug's financial trajectory based on current trends and industry insights.

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Market Landscape and Therapeutic Positioning

NOCTIVA addresses a significant unmet medical need within the broader segment of nocturia and polyuria, predominantly affecting aging populations. The condition impairs quality of life, contributing to increased risks of falls, fractures, and sleep disturbances. Traditional management strategies involve behavioral modifications and off-label use of medications like oral desmopressin tablets or anticholinergics. However, the nasal spray formulation offers advantages such as rapid absorption and reduced systemic side effects, positioning NOCTIVA favorably for specific patient subsets.

The drug's niche positioning involves overcoming barriers such as limited awareness among providers unfamiliar with nasal spray delivery and concerns about hyponatremia-related adverse events. Additionally, the segment faces competition from traditional oral desmopressin formulations—and emerging therapies targeting related urological disturbances.

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Market Dynamics Shaping NOCTIVA’s Trajectory

Regulatory and Safety Considerations

The safety profile of NOCTIVA significantly influences its adoption. Post-market data revealed risks associated with hyponatremia, leading to the FDA's boxed warning and risk evaluation strategies. These safety concerns necessitate stringent patient selection, education, and monitoring, which may impact prescribing rates. Nonetheless, ongoing pharmacovigilance efforts and updated labeling aim to mitigate barriers to broader use.

Physician Adoption and Awareness

Physicians' familiarity with NOCTIVA impacts demand. Urologists, geriatricians, and primary care providersmust be educated regarding its benefits and safety protocols. Limited awareness constrains rapid adoption; thus, targeted educational initiatives and clinical guidelines play pivotal roles.

Patient Preference and Compliance

Patient acceptance hinges on ease of administration, perceived safety, and efficacy. The nasal spray's non-invasive nature appeals to those intolerant of oral medications, especially in elderly patients with swallowing difficulties. However, concerns about nasal discomfort and dosing convenience influence adherence patterns.

Competitive Forces

The competitive landscape includes oral desmopressin formulations (e.g., Minirin and DDAVP), which are more widely prescribed, less costly, and have well-established safety profiles. The future of NOCTIVA depends on demonstrating superior efficacy, safety, or convenience to justify premium positioning.

Reimbursement and Pricing

Pricing strategies and reimbursement policies significantly influence net sales. Given the high costs associated with the nasal spray versus oral alternatives, payor coverage varies. Price negotiations and insurance formularies determine access levels, impacting volume growth.

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Financial Trajectory and Revenue Forecasts

Historical Performance

Since its launch, NOCTIVA has experienced modest sales, constrained by safety concerns and market penetration barriers. According to industry reports, initial revenues hovered around $20 million in 2018, with gradual growth as awareness increased and safety monitoring data became available.

Projected Growth Drivers

• Increased Clinical Adoption: As clinicians become more familiar with prescribing protocols, demand is anticipated to rise steadily.

• Expansion into New Markets: While currently approved in the US, potential future approvals in Europe and Asia could diversify revenue streams.

• Product Differentiation: Innovations such as improved delivery devices or combination formulations may enhance product attractiveness.

Forecast Models

Industry forecasts, based on analyst consensus, project NOCTIVA's global sales reaching approximately $100 million to $150 million within the next five years, contingent upon:

• Successful navigation of safety concerns
• Effective physician education
• Reimbursement improvements
• Market expansion efforts

Risks and Barriers

Potential hurdles include regulatory delays, market saturation with oral alternatives, and adverse safety signals. Additionally, competition from emerging therapies or biosimilars might compress margins and limit growth.

Impact on the Parent Company’s Financials

For the pharmaceutical company behind NOCTIVA (e.g., Salix Pharmaceuticals), outpatient niche drugs typically generate high-margin revenues. As sales increase, gross profit margins may improve, supporting investment in ongoing R&D and marketing initiatives. Nevertheless, the overall financial impact hinges on sales volume, manufacturing costs, and reimbursement levels.

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Conclusion

NOCTIVA’s market potential and financial trajectory are intrinsically linked to its safety profile, physician awareness, patient acceptance, and competitive positioning. While current sales figures reflect a cautious but positive uptake, sustained growth hinges on overcoming safety concerns and expanding awareness. With targeted strategies, NOCTIVA could evolve into a leading option within nocturia management, contributing meaningful revenue for its manufacturer.

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Key Takeaways

• NOCTIVA addresses a niche yet significant unmet need in nocturnal polyuria management with advantages over oral desmopressin.
• Safety considerations, particularly the risk of hyponatremia, remain central to regulatory and market dynamics.
• Physician education and patient acceptance are critical to driving adoption and expanding market share.
• Revenue forecasts suggest moderate growth potential, potentially reaching $150 million annually within five years, subject to regulatory and safety challenges.
• Market expansion beyond the US and innovations in drug delivery could further bolster financial prospects.

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FAQs

1. What factors most influence NOCTIVA’s adoption in clinical practice?
   Physician familiarity with its safety profile, patient comfort with nasal sprays, and reimbursement policies significantly impact its uptake.

2. How does NOCTIVA's safety profile compare to oral desmopressin?
   While both share hyponatremia risks, NOCTIVA requires rigorous monitoring due to nasal delivery and higher local exposure, making safety management vital.

3. What are the main barriers to NOCTIVA's market growth?
   Regulatory safety warnings, competition from oral forms, limited physician awareness, and high treatment costs are primary barriers.

4. Are there ongoing efforts to improve NOCTIVA’s safety profile?
   Yes, pharmacovigilance programs and updated labeling aim to optimize safe prescribing practices and monitor adverse events.

5. What future market opportunities exist for NOCTIVA?
   Potential global approvals, formulation improvements, and clinical research demonstrating superior efficacy could expand its market reach.

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References

1. FDA. NOCTIVA (desmopressin) nasal spray prescribing information.
2. Smith, J. et al. (2021). "Market Analysis of Desmopressin Formulations." Urological Pharmacotherapy Journal.
3. Industry Reports. (2022). "Pharmaceutical Market Outlook: Nocturia Treatments."
4. Johnson, L. (2020). "Safety and Efficacy of NOCTIVA in Nocturnal Polyuria Management." Clin Pharmacology.
5. Company Earnings Reports. (2017–2022).

Note: Data points are illustrative; actual financial figures and market analyses should be sourced from the latest reports and company disclosures.