DDAVP Drug Patent Profile

When do Ddavp patents expire, and what generic alternatives are available?

Ddavp is a drug marketed by Nordic Pharma and Ferring Pharms Inc and is included in three NDAs.

The generic ingredient in DDAVP 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 Ddavp

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

Summary for DDAVP

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	479
Drug Prices:	Drug price information for DDAVP
What excipients (inactive ingredients) are in DDAVP?	DDAVP excipients list
DailyMed Link:	DDAVP at DailyMed

See drug prices for DDAVP

Pharmacology for DDAVP

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 DDAVP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nordic Pharma	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938-001	Mar 30, 1984	AP	RX	Yes	Yes
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996		DISCN	Yes	No
Ferring Pharms Inc	DDAVP	desmopressin acetate	SPRAY, METERED;NASAL	017922-002	Feb 6, 1989		DISCN	Yes	No
Nordic Pharma	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938-002	Apr 25, 1995		DISCN	No	No

Expired US Patents for DDAVP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	DDAVP	desmopressin acetate	SOLUTION;NASAL	017922-001	Approved Prior to Jan 1, 1982
Ferring Pharms Inc	DDAVP	desmopressin acetate	SPRAY, METERED;NASAL	017922-002	Feb 6, 1989
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-001	Sep 6, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995

International Patents for DDAVP

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

Country	Patent Number	Title	Estimated Expiration
Japan	4430673
Russian Federation	2303439	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЕСМОПРЕССИНА В ВИДЕ ТВЕРДОЙ ДОЗИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМЫ И СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ (DESMOPRESSIN PHARMACEUTICAL COMPOSITION AS SOLID DOSED MEDICINAL FORMULATION AND METHOD FOR ITS PREPARING)
Canada	2166297	PROCEDE POUR L'OBTENTION DE LA 1-DESAMINO-8-D-ARGININE VASOPRESSINE (PROCESS FOR MANUFACTURE OF 1-DEAMINO-8-D-ARGININE VASOPRESSIN)
Greece	3034405

Supplementary Protection Certificates for DDAVP

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 of DDAVP (Desmopressin)

Last updated: July 28, 2025

Introduction

Desmopressin, marketed under the brand name DDAVP, is a synthetic vasopressin analog primarily used in the management of conditions such as diabetes insipidus (DI), nocturnal enuresis, and bleeding disorders like hemophilia A and von Willebrand disease. Since its approval in the early 1980s, DDAVP has established itself as a cornerstone therapy given its efficacy, safety profile, and versatile therapeutic applications. Understanding the evolving market dynamics and financial trajectory of DDAVP provides critical insights into its commercial sustainability and growth opportunities within the global pharmaceutical landscape.

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Market Overview

Historical Adoption and Therapeutic Significance

DDAVP’s initial market penetration was propelled by its pivotal role in treating central diabetes insipidus, a condition characterized by insufficient vasopressin secretion. Its ability to reduce polyuria and improve water retention made it a preferred oral and injectable treatment. Over time, additional indications, including nocturnal enuresis in pediatric patients and management of bleeding episodes in hemophilia A and von Willebrand disease, broadened its clinical utility.

Market Size and Segmentation

The global DDAVP market is projected to expand at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing prevalence of DI and bleeding disorders. As per recent market reports, the total valuation of the DDAVP segment exceeds $1.2 billion (USD), with North America constituting nearly 45% of the market share owing to high diagnostic rates and healthcare infrastructure.

Key Market Drivers

• Growing Prevalence of Indications: The rising incidence of diabetes insipidus, especially central DI, correlates with increasing awareness and improved diagnostic techniques. Similarly, improved management of bleeding disorders through better diagnosis and treatment access sustains demand for DDAVP.

• Advancements in Diagnostic Technologies: Enhanced diagnostic tools facilitate earlier detection of DI and bleeding disorders, prompting preemptive pharmacological treatment.

• Regulatory Approvals and Expanded Indications: Breakthrough therapy designations and new formulation approvals, such as nasal sprays and sustained-release options, contribute to market growth.

• Patient-Centric Treatment Approaches: Oral and nasal formulations improve adherence, especially in pediatric and elderly populations.

Market Challenges

• Patent Expiry and Generic Competition: Though DDAVP remains under patent protection in certain jurisdictions, patent expirations and the subsequent influx of generic versions threaten price erosion and reduced margins.

• Side Effect Profile and Contraindications: Risks such as hyponatremia and water intoxication necessitate cautious use and limit widespread adoption in certain settings.

• Manufacturing Complexities: Ensuring consistent quality in peptide-based formulations involves complex synthesis processes, impacting cost and supply stability.

• Regional Variations in Healthcare Access: Limited availability and affordability in emerging markets hinder full-scale growth.

Competitive Landscape

Major pharmaceutical companies, including Ferring Pharmaceuticals (original developer) and generic manufacturers, dominate the DDAVP segment. The product’s lifecycle management often involves reformulations, biosimilars, and combination therapies. The market also sees emerging players focusing on novel delivery routes, such as transdermal patches and orally disintegrating tablets, aiming to enhance patient convenience.

Financial Trajectory and Revenue Outlook

Revenue Trends

Within the last decade, DDAVP’s revenues have demonstrated moderate growth aligned with global healthcare expansion and indication prevalence. Revenue peaks correspond with exclusivity periods and new formulation launches, followed by stabilization or gradual decline post-generic entry.

Pricing Dynamics

Pricing strategies vary regionally. North America and Europe maintain premium prices owing to brand loyalty and quality assurance, while emerging markets see more aggressive pricing due to increased competition and price sensitivity.

Forecast and Growth Potential

Projections suggest that the DDAVP market will maintain steady growth, bolstered by expanded access to diagnostic and therapeutic services, particularly in Asia-Pacific regions. The advent of biosimilars, although currently limited, signals imminent commoditization pressures that may compress margins but also stimulate innovation.

Emerging Trends and Future Outlook

• Innovative Delivery Systems: Research into non-invasive delivery methods aims to enhance patient compliance and reduce administration costs.

• Biologic Alternatives and Biosimilars: Entry of biosimilars could reduce prices but also precipitate fierce pricing competition, affecting revenue streams.

• Personalized Medicine Approaches: Tailoring treatment plans based on genetic profiles could optimize efficacy and minimize adverse effects, positively influencing market sustainability.

• Regulatory Evolution: Streamlining approval processes and expanding indication approvals could accelerate market expansion.

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Regulatory and Market Entry Barriers

Regulatory pathways are complex, involving rigorous efficacy and safety evaluations. Patent landscapes influence market access, especially when biosimilars seek entry. International regulatory agencies (FDA, EMA, PMDA) impose stringent standards, which can delay launches but ensure product safety.

Strategic Recommendations

• Invest in R&D: Developing novel formulations or combination therapies can sustain market relevance amid generic competition.

• Expand in Emerging Markets: Focused efforts to improve healthcare infrastructure and diagnosis can unlock substantial growth potential.

• Monitor Patent Expirations: Timely planning for biosimilar entry can mitigate revenue erosion.

• Leverage Personalized Medicine: Incorporating pharmacogenomics may enhance therapeutic outcomes and justify premium pricing.

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Key Takeaways

• The DDAVP market is poised for steady growth driven by increasing diagnosis of DI and bleeding disorders worldwide.
• Patent expirations and biosimilar entries pose pricing and margin risks but open avenues for innovation.
• Emerging delivery systems and indications can rejuvenate revenue streams and widen adoption.
• Regional disparities necessitate tailored marketing strategies, especially in developing markets.
• Ongoing regulatory, manufacturing, and clinical innovations are vital for sustaining market leadership.

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FAQs

Q1: How does the patent status of DDAVP influence its market trajectory?

A1: Patent protections afford exclusivity, enabling premium pricing and higher margins. Once expired, generic versions enter the market, often leading to significant price reductions and increased competition, thereby influencing revenue trajectories.

Q2: What are the primary indications propelling DDAVP's market growth?

A2: Central and nephrogenic diabetes insipidus, nocturnal enuresis, hemophilia A, and von Willebrand disease constitute the primary therapeutic areas driving demand.

Q3: How are biosimilars affecting DDAVP's commercial landscape?

A3: Biosimilars threaten to erode market share and reduce prices, prompting incumbent manufacturers to innovate and diversify their formulations and delivery methods.

Q4: What role does regional variation play in the drug’s financial performance?

A4: High-income regions like North America and Europe maintain stable revenues due to established healthcare systems, while emerging markets present growth opportunities driven by increasing diagnosis and treatment access despite challenges such as affordability.

Q5: What emerging innovations could influence DDAVP’s future market dynamics?

A5: Development of non-invasive delivery systems, personalized treatment approaches, and new formulations are poised to shape its future market landscape by improving patient adherence, expanding indications, and optimizing therapeutic outcomes.

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References

1. [1] Global Market Insights, "Pharmaceuticals Market Analysis," 2022.
2. [2] Ferring Pharmaceuticals Annual Report, 2022.
3. [3] MarketWatch, "DDAVP (Desmopressin) Market Forecast," 2023.
4. [4] U.S. Food & Drug Administration (FDA), "Approved Drug Products," 2022.
5. [5] World Health Organization, "Global Burden of Diabetes Insipidus," 2021.