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-five 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	1
Patent Applications:	402
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

Pharmacology for NOCDURNA

Drug Class	Factor VIII Activator Vasopressin Analog
Physiological Effect	Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

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	022517-001	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	022517-001	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
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
Croatia	P20190114
European Patent Office	3225249
Norway	2296686
Poland	3225249
Spain	2462465

Supplementary Protection Certificates for NOCDURNA

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	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
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	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

Introduction

NOCDURNA, a vasopressin analog developed by Ferring Pharmaceuticals, is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. This article delves into the market dynamics and financial trajectory of NOCDURNA, highlighting its clinical significance, market performance, and financial implications.

Clinical Significance of NOCDURNA

NOCDURNA is a synthetic analogue of the endogenous human anti-diuretic hormone, 8-vasopressin. It works by stimulating the reabsorption of water from the renal collecting ducts, resulting in more concentrated urine and reduced nighttime urine production[4].

Target Population and Indication

NOCDURNA is specifically designed for adults experiencing nocturia due to nocturnal polyuria, a condition characterized by the overproduction of urine at night. The drug is administered sublingually, with dosages of 27.7 mcg for women and 55.3 mcg for men, taken one hour before bedtime[4].

Market Approval and Regulatory Status

NOCDURNA received FDA approval in 2018 for its sublingual tablet formulation, following a series of Phase 3 clinical trials that demonstrated its efficacy in reducing nocturnal voids. This approval marked a significant milestone, as NOCDURNA became one of the few treatments specifically indicated for nocturia due to nocturnal polyuria[4].

Market Dynamics

Competitive Landscape

The market for nocturia treatments is relatively niche but growing, driven by the increasing prevalence of nocturnal polyuria among older adults. NOCDURNA competes with other desmopressin formulations, such as Noctiva, a nasal spray formulation approved by the FDA in 2017. However, NOCDURNA's sublingual administration offers a distinct advantage in terms of patient compliance and convenience[4].

Patient Demographics

Clinical trials for NOCDURNA involved a diverse population, with a mean age of 59 years for women and 62 years for men. A significant portion of the participants were aged 65 and older, reflecting the demographic most affected by nocturia. The trials also included a diverse racial and ethnic mix, with Caucasians, Blacks, and Asians represented[1].

Financial Trajectory

Revenue Impact

While specific revenue figures for NOCDURNA are not publicly disclosed, its approval and market entry have contributed to the overall revenue growth of Ferring Pharmaceuticals. The success of NOCDURNA is part of a broader trend in pharmaceuticals where niche treatments for specific conditions are driving revenue growth.

Pharmaceutical Company Performance

Companies like Avadel Pharmaceuticals, which have a portfolio that includes treatments for similar conditions, provide insight into the financial dynamics. Avadel's revenue from products like Akovaz, which was launched in 2016, shows how new product launches can significantly impact a company's financial performance. Although NOCDURNA is not directly mentioned in Avadel's financial reports, the success of similar products indicates a positive financial trajectory for NOCDURNA[3].

Adverse Reactions and Safety Profile

The financial success of NOCDURNA is also influenced by its safety profile. Common adverse reactions include dry mouth, hyponatremia (low blood sodium levels), and dizziness. Hyponatremia, in particular, is a significant risk, with incidence rates varying by dose and patient demographics. Effective management of these risks is crucial for maintaining market confidence and patient adherence[1].

Market Penetration and Growth Potential

NOCDURNA's market penetration is driven by its unique formulation and the growing awareness of nocturia as a treatable condition. The drug's ability to reduce nocturnal voids significantly improves the quality of life for patients, which can lead to increased prescription rates and market growth.

Financial Guidance and Projections

While direct financial projections for NOCDURNA are not available, the broader pharmaceutical industry trends suggest continued growth. Companies like Halozyme, which have seen significant revenue increases due to their portfolio of innovative treatments, indicate a favorable market environment for new and effective treatments like NOCDURNA[2][5].

Key Takeaways

• Clinical Efficacy: NOCDURNA is effective in reducing nocturnal voids due to nocturnal polyuria.
• Market Approval: FDA-approved in 2018 for its sublingual tablet formulation.
• Competitive Advantage: Unique sublingual administration offers convenience and compliance benefits.
• Financial Impact: Contributes to the revenue growth of Ferring Pharmaceuticals, though specific figures are not disclosed.
• Safety Profile: Common adverse reactions include dry mouth, hyponatremia, and dizziness.
• Market Growth: Driven by growing awareness of nocturia and the drug's unique formulation.

FAQs

What is NOCDURNA used for?

NOCDURNA is used for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void.

How is NOCDURNA administered?

NOCDURNA is administered sublingually, with dosages of 27.7 mcg for women and 55.3 mcg for men, taken one hour before bedtime.

What are the common adverse reactions of NOCDURNA?

Common adverse reactions include dry mouth, hyponatremia (low blood sodium levels), and dizziness.

Is NOCDURNA FDA-approved?

Yes, NOCDURNA received FDA approval in 2018 for its sublingual tablet formulation.

How does NOCDURNA compare to other desmopressin formulations?

NOCDURNA's sublingual administration offers a distinct advantage in terms of patient compliance and convenience compared to other formulations like Noctiva, a nasal spray.

Sources

1. Drugs.com: NOCDURNA: Package Insert / Prescribing Information.
2. PR Newswire: Halozyme Reports Fourth Quarter and Full Year 2022 Financial and Operating Results.
3. Avadel Pharmaceuticals: 2018 Financial Report.
4. FDA: Multi-Discipline Review and Evaluation for NOCDURNA.
5. PR Newswire: Halozyme Reports Second Quarter 2023 Financial and Operating Results.