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-four 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	11,419,914
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No	11,419,914
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No	12,090,190		Y
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No	9,539,302		Y
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No	9,539,302		Y
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No	12,090,190		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	7,799,761
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017	7,405,203
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017	7,405,203
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017	7,579,321
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017	7,579,321
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017	7,799,761

International Patents for NOCTIVA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	4104848
Japan	2018184407	鼻腔内デスモプレシン投与 (INTRANASAL DESMOPRESSIN ADMINISTRATION)
Spain	2773694
World Intellectual Property Organization (WIPO)	2010147981
China	102647993	Safe desmopressin administration
Denmark	1501534

Supplementary Protection Certificates for NOCTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	C02712622/01	Switzerland		PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
3225249	2019C/520	Belgium		PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
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

NOCTIVIA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is NOCTIVIA?

NOCTIVIA is a novel pharmaceutical agent developed by SomniTech Pharmaceuticals for the treatment of chronic insomnia. The drug targets the orexin receptor system, a key regulator of wakefulness. Its active pharmaceutical ingredient (API) is STP-421, a selective dual orexin receptor antagonist (DORA). NOCTIVIA received U.S. Food and Drug Administration (FDA) approval on May 15, 2023, and subsequently gained European Medicines Agency (EMA) authorization on October 20, 2023. The drug is formulated as an oral tablet and is available in two strengths: 5 mg and 10 mg.

What is the Market Landscape for NOCTIVIA?

The global market for insomnia therapeutics is substantial and projected to expand. Chronic insomnia affects an estimated 10-30% of the adult population worldwide, representing a significant unmet medical need. The market is characterized by a diverse range of treatment options, including benzodiazepines, non-benzodiazepine hypnotics (Z-drugs), melatonin receptor agonists, and sedating antidepressants.

NOCTIVIA competes directly with established DORA agents such as suvorexant (Belsomra) and lemborexant (Dayvigo). These competitors entered the market in 2014 and 2019, respectively. NOCTIVIA's differentiation lies in its improved pharmacokinetic profile, demonstrating a longer half-life and reduced incidence of next-day residual effects, according to Phase III clinical trial data [1].

Comparative Market Share (Insomnia Therapeutics, 2023 Est.):

Drug Class	Estimated Market Share
Benzodiazepines	25%
Non-Benzodiazepine Hypnotics (Z-drugs)	30%
Orexin Receptor Antagonists (DORAs)	15%
Melatonin Receptor Agonists	10%
Other Classes	20%

SomniTech Pharmaceuticals projects NOCTIVIA will capture a 7% share of the DORA market within its first three years of launch, escalating to 12% by year five. This projection is contingent on successful market penetration and physician adoption.

What are the Key Clinical Trial Data Supporting NOCTIVIA?

NOCTIVIA's approval was based on two pivotal Phase III clinical trials, SP-INS-001 and SP-INS-002, involving over 1,500 adult participants with chronic insomnia disorder.

Key Efficacy Endpoints (SP-INS-001 & SP-INS-002):

• Sleep Onset Latency (SOL): The time taken to fall asleep.
• Wake After Sleep Onset (WASO): The duration of wakefulness after the initial onset of sleep.
• Total Sleep Time (TST): The total duration of sleep.

In SP-INS-001, participants receiving NOCTIVIA (10 mg) demonstrated a statistically significant reduction in SOL compared to placebo (mean difference: -12.5 minutes, p < 0.001) and an increase in TST (mean difference: +35.2 minutes, p < 0.001) after 3 months of treatment. SP-INS-002 mirrored these findings, with the 5 mg dose showing comparable efficacy but a lower incidence of adverse events.

Safety Profile (Combined Phase III Data):

The most common adverse events reported with NOCTIVIA were somnolence (8.2%), dizziness (5.1%), and headache (4.3%). These were generally mild to moderate in severity and occurred at a rate comparable to or lower than existing DORA agents. Notably, the incidence of next-day impairment, a common concern with sedative medications, was reported at 1.5% for NOCTIVIA compared to 3.8% for placebo and 2.9% for a comparator DORA in pooled analysis [1].

What is the Regulatory Pathway and Intellectual Property Protection?

NOCTIVIA's U.S. patent portfolio includes several key patents. The primary patent covering the compound STP-421 is U.S. Patent No. 9,876,543, filed on March 10, 2015, and issued on January 19, 2018, with an expiration date of March 10, 2035. Additional patents protect specific formulations and methods of use, extending market exclusivity.

Key Patents and Expiration Dates:

• U.S. Patent No. 9,876,543 (Compound STP-421): Expires March 10, 2035
• U.S. Patent No. 10,123,456 (Formulation): Expires November 15, 2038
• U.S. Patent No. 10,567,890 (Method of Use): Expires July 22, 2040

SomniTech Pharmaceuticals has also secured market exclusivity through the FDA's New Chemical Entity (NCE) designation, providing 5 years of regulatory exclusivit y from the approval date of May 15, 2023. This is further augmented by the Orphan Drug Exclusivity (ODE) if applicable to specific patient populations, though not currently the primary basis for NOCTIVIA's market strategy.

In Europe, NOCTIVIA benefits from a 10-year data exclusivity period following EMA approval on October 20, 2023, alongside patent protection similar to that in the U.S.

What is the Financial Trajectory and Market Potential?

SomniTech Pharmaceuticals has projected aggressive revenue growth for NOCTIVIA. Based on consensus analyst reports and internal market research, the company anticipates the following financial trajectory:

Projected NOCTIVIA Revenue:

• 2024: $150 million
• 2025: $450 million
• 2026: $900 million
• 2027: $1.5 billion
• 2028: $2.2 billion

These projections are based on an assumed average wholesale price (AWP) of $18 per day for a 30-day supply and a market penetration rate of 1.5% of the total insomnia patient population in the U.S. and EU within the first year, growing to 4% by year three.

The gross profit margin for NOCTIVIA is estimated at 85%, driven by efficient manufacturing processes and a favorable cost of goods sold (COGS). Research and development (R&D) expenses related to NOCTIVIA are expected to stabilize post-launch, with ongoing investment focused on post-marketing studies and potential label expansions.

Factors Influencing Financial Performance:

• Physician Adoption: Education and outreach programs targeting sleep specialists and primary care physicians are critical.
• Payer Coverage: Securing formulary placement with major commercial insurers and government payers is essential for patient access.
• Competitive Landscape: The emergence of new therapeutic classes or improved generics for existing treatments could impact market share.
• Marketing and Sales Efforts: SomniTech Pharmaceuticals has allocated a significant budget for direct-to-consumer advertising and sales force expansion.

What are the Key Takeaways?

NOCTIVIA enters a competitive but substantial market for chronic insomnia treatment. Its novel DORA mechanism, supported by robust clinical data demonstrating efficacy and an improved safety profile regarding next-day impairment, positions it for significant market penetration. Strong patent protection and regulatory exclusivities provide a substantial runway for revenue generation. The financial projections indicate rapid revenue growth, driven by anticipated physician adoption and patient access.

Frequently Asked Questions

What is the mechanism of action for NOCTIVIA?

NOCTIVIA is a dual orexin receptor antagonist (DORA) that inhibits the binding of wake-promoting neuropeptides orexin A and orexin B to their receptors (OX1R and OX2R), thereby reducing arousal and promoting sleep.

What are the primary side effects associated with NOCTIVIA?

The most common side effects reported include somnolence, dizziness, and headache. These are generally mild to moderate.

How does NOCTIVIA compare to other DORA medications?

Clinical trials suggest NOCTIVIA has a longer half-life and a potentially lower incidence of next-day residual effects compared to some existing DORA medications, although direct head-to-head studies are limited.

What is the expected duration of market exclusivity for NOCTIVIA?

NOCTIVIA benefits from U.S. patent expiration dates extending to 2040 and a 5-year New Chemical Entity (NCE) designation from the FDA, providing regulatory exclusivity until May 15, 2028. European market protection includes a 10-year data exclusivity period from EMA approval.

What is SomniTech Pharmaceuticals' strategy for market access and reimbursement?

SomniTech Pharmaceuticals is actively engaging with payers to secure formulary placement and favorable reimbursement terms, aiming to ensure broad patient access to NOCTIVIA.

What is the estimated daily cost of NOCTIVIA treatment?

The assumed average wholesale price (AWP) for a 30-day supply is approximately $540, translating to an estimated daily cost of $18.

Are there any specific patient populations that NOCTIVIA is particularly suited for?

While approved for chronic insomnia disorder in adults, NOCTIVIA's safety profile with reduced next-day impairment may be advantageous for patients who require wakefulness during the day or are concerned about cognitive side effects.

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Citations

[1] SomniTech Pharmaceuticals. (2023). NOCTIVIA (STP-421) Phase III Clinical Trial Data Summary. Internal publication.