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 four patents protecting this drug.

This drug has one hundred and seventeen patent family members in thirty-one countries.

The generic ingredient in NOCTIVA 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 Noctiva

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

Summary for NOCTIVA

International Patents:	117
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	402
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 four 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			Y
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
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	201656-002	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	201656-001	Mar 3, 2017
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	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
World Intellectual Property Organization (WIPO)	2010075266
China	102647993
Norway	335167
South Korea	20170123713
Japan	2016014059
China	108295241	安全的去氨加压素给药 (Safe desmopressin administration)

Supplementary Protection Certificates for NOCTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2712622	C02712622/01	Switzerland		PRODUCT NAME: DESMOPRESSIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66379 16.03.2018
2712622	LUC00015	Luxembourg		PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
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
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

NOCTIVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NOCTIVA

Introduction

NOCTIVA, a desmopressin acetate nasal spray, is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults. This article delves into the market dynamics and financial trajectory of NOCTIVA, highlighting its launch, performance, and the challenges it has faced.

Market Need and Target Population

NOCTIVA addresses a significant medical need by treating nocturia, a condition characterized by the need to urinate at least twice during the night. The target population includes adults, particularly those 50 years and older, with nocturnal polyuria, which is defined as night-time urine production exceeding one-third of the 24-hour urine production[4].

Launch and Initial Performance

NOCTIVA was launched in March 2018 by Avadel Pharmaceuticals. The initial performance was marked by significant marketing efforts, with sales and marketing costs associated with the launch amounting to approximately $48,500. This was partially offset by lower SG&A spend related to the divestiture of Avadel's pediatric assets[3].

Clinical Efficacy and Quality of Life Impact

Clinical trials demonstrated that NOCTIVA significantly improved the quality of life for patients. Patients treated with NOCTIVA were three times more likely to report no difficulty getting enough sleep and five times more likely to report no bother due to nocturia compared to baseline levels. At the end of 12 weeks, a substantial percentage of patients reported no difficulty getting enough sleep and no bother due to nocturia[1].

Financial Performance

Revenue

In the year ended December 31, 2018, NOCTIVA contributed $1,204 to Avadel's total product sales. This was a modest start, given that the product was launched mid-year. The overall revenue for Avadel during this period was $101,423, down from $172,841 in the prior year, primarily due to declines in other product lines such as Bloxiverz and Akovaz[3].

Gross Profit and Expenses

The gross profit for Avadel in 2018 decreased by 45.4% to $85,753, largely due to decreased turnover of other products. The launch of NOCTIVA added to the research and development (R&D) costs, which increased by 17.7% during the year. Distribution and administrative expenses also rose significantly, driven by the marketing costs for NOCTIVA[3].

Challenges and Risks

Market Competition

NOCTIVA faces competition from other treatments for nocturia. Avadel's internal analyses may overstate the market opportunity, and the company must effectively increase awareness of nocturia and the benefits of NOCTIVA to capture market share[1].

Safety and Drug Interactions

One of the significant risks associated with NOCTIVA is the potential for hyponatremia, particularly in older patients and those taking concomitant medications like systemic or inhaled glucocorticoids and NSAIDs. This risk necessitates careful patient monitoring and management[4].

Financial Risks

Avadel's financial performance is also subject to various risks, including those related to its exchangeable senior notes, the divestiture of its pediatric business, and the license agreement with Serenity Pharmaceuticals. These factors can impact the company's ability to successfully commercialize NOCTIVA[1].

Acquisition and Current Status

In 2022, Acerus Pharmaceuticals acquired Serenity and the global rights to NOCTIVA. This acquisition marked a new chapter in the drug's commercialization. Acerus reported improved revenue in 2021, partly due to the growth in product sales, including those related to NOCTIVA[5].

Financial Results Post-Acquisition

Acerus's financial results for 2021 showed a net loss, but the company saw improvements in gross profit compared to the prior year. The acquisition of NOCTIVA and other products contributed to this improvement, despite ongoing challenges such as high research and development costs and significant operating expenses[5].

Key Takeaways

• Market Need: NOCTIVA addresses a significant medical need for adults with nocturia due to nocturnal polyuria.
• Clinical Efficacy: The drug has shown substantial improvements in patients' quality of life.
• Financial Performance: Initial revenue was modest, with significant marketing and R&D expenses.
• Challenges: Market competition, safety risks, and financial uncertainties pose challenges.
• Acquisition: Acerus's acquisition of NOCTIVA has marked a new phase in its commercialization.

FAQs

What is NOCTIVA used for?

NOCTIVA is used for the treatment of nocturia due to nocturnal polyuria in adults.

When was NOCTIVA launched?

NOCTIVA was launched in March 2018 by Avadel Pharmaceuticals.

What are the clinical benefits of NOCTIVA?

Patients treated with NOCTIVA are more likely to report no difficulty getting enough sleep and no bother due to nocturia.

What are the potential risks associated with NOCTIVA?

One of the significant risks is the potential for hyponatremia, particularly in older patients and those taking certain concomitant medications.

Who currently holds the rights to NOCTIVA?

Acerus Pharmaceuticals acquired the global rights to NOCTIVA in 2022.

Sources

1. Avadel Pharmaceuticals: "Avadel Presents Data on Quality of Life Improvement in Patients on NOCTIVA™" - October 29, 2018.
2. BioSpace: "Acerus Reports Second Quarter 2022 Financial Results" - August 9, 2022.
3. Avadel Pharmaceuticals: "AVADEL PHARMACEUTICALS PLC" - June 13, 2019.
4. RxList: "Noctiva (Desmopressin Acetate Nasal Spray)".
5. GlobeNewswire: "Acerus Reports Fourth Quarter and Full Year 2021 Financial Results" - March 15, 2022.