DDAVP (NEEDS NO REFRIGERATION) Drug Patent Profile

Which patents cover Ddavp (needs No Refrigeration), and what generic alternatives are available?

Ddavp (needs No Refrigeration) is a drug marketed by Ferring Pharms Inc and is included in one NDA.

The generic ingredient in DDAVP (NEEDS NO REFRIGERATION) 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 (needs No Refrigeration)

A generic version of DDAVP (NEEDS NO REFRIGERATION) was approved as desmopressin acetate by MEITHEAL on October 15^th, 1997.

Summary for DDAVP (NEEDS NO REFRIGERATION)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	28
Patent Applications:	230
DailyMed Link:	DDAVP (NEEDS NO REFRIGERATION) at DailyMed

Recent Clinical Trials for DDAVP (NEEDS NO REFRIGERATION)

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	NA
Second Affiliated Hospital of Wenzhou Medical University	PHASE1
Kashiv BioSciences, LLC	PHASE1

See all DDAVP (NEEDS NO REFRIGERATION) clinical trials

US Patents and Regulatory Information for DDAVP (NEEDS NO REFRIGERATION)

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	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996		DISCN	Yes	No

Expired US Patents for DDAVP (NEEDS NO REFRIGERATION)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996

International Patents for DDAVP (NEEDS NO REFRIGERATION)

See the table below for patents covering DDAVP (NEEDS NO REFRIGERATION) around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2166297	PROCEDE POUR L'OBTENTION DE LA 1-DESAMINO-8-D-ARGININE VASOPRESSINE (PROCESS FOR MANUFACTURE OF 1-DEAMINO-8-D-ARGININE VASOPRESSIN)
Portugal	708657
Slovakia	281470
Slovakia	282844
Portugal	710247
European Patent Office	0710122	COMPOSITIONS PHARMACEUTIQUES PEPTIDIQUES STABILISEES (STABILIZED PHARMACEUTICAL PEPTIDE COMPOSITIONS)

Supplementary Protection Certificates for DDAVP (NEEDS NO REFRIGERATION)

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
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
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	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

Market Dynamics and Financial Trajectory for DDAVP (Desmopressin, No Refrigeration Needed)

Last updated: July 28, 2025

Introduction

DDAVP, known generically as desmopressin, is a synthetic analog of vasopressin widely used to treat conditions such as diabetes insipidus, nocturnal enuresis, and certain bleeding disorders. Its unique formulation, notably the non-refrigerated version, has significantly influenced global accessibility, supply chains, and market competitiveness. This analysis evaluates the current market landscape, factors shaping its trajectory, and the financial implications for stakeholders.

Market Overview

Product Profile and Advantages

Desmopressin's critical advantage lies in its stabilized, non-refrigerated form, facilitating widespread use in both developed and emerging markets. Unlike traditional formulations requiring cold storage, the stability at room temperature reduces logistical burdens, costs, and barriers to distribution, especially in regions with limited cold chain infrastructure.

Indications and Market Penetration

Primarily approved for central diabetes insipidus, nocturnal enuresis, and certain bleeding disorders (such as hemophilia A), DDAVP has garnered over $1 billion in annual sales globally, according to IQVIA data[1]. Its versatility and oral, intranasal, and injectable forms have allowed extensive market penetration.

Geographic Market Distribution

North America remains the dominant market, driven by high diagnosis rates and reimbursement robustness. Europe also holds significant market share, with increasing adoption in Asia-Pacific driven by emerging healthcare infrastructure. Developing countries, historically limited by cold chain logistics, benefit greatly from the room-temperature stability of non-refrigerated DDAVP formulations.

Market Dynamics

Supply Chain and Manufacturing Factors

The shift towards non-refrigerated formulations has transformed production dynamics. Manufacturers have invested in stabilization technology, reducing costs associated with cold chain logistics and inventory management. This shift enhances scalability, especially in remote regions.

Regulatory Landscape

Regulatory agencies, such as the FDA and EMA, approve non-refrigerated formulations based on stability data. These approvals influence market access, fostering competition and potentially lowering prices. Notably, regulatory pathways for biosimilars and generics have become more streamlined for stable formulations, accelerating market entry.

Competitive Landscape

Major companies like Ferring Pharmaceuticals and Novo Nordisk dominate the DDAVP market. The advent of biosimilars has intensified competition, pressuring prices and widening access. Non-refrigeration stability acts as a differentiation factor, enabling manufacturers to expand in developing markets with limited cold chain infrastructure.

Technological Innovations

Advancements in formulation technology—such as lyophilization and microencapsulation—have supported the development of stable, room-temperature desmopressin products. These innovations may further extend patent life, delay generic entry, and influence pricing strategies.

Patient and Provider Preferences

The convenience of non-refrigerated DDAVP enhances patient compliance and adherence, particularly in pediatric and elderly populations. Healthcare providers favor formulations that simplify storage and administration, fostering increased prescription rates.

Financial Trajectory

Revenue Trends

The market for non-refrigerated DDAVP is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years[2]. Growth is driven by expanding indications, increased diagnosis rates, and adoption in emerging markets.

Pricing Dynamics

While the initial premium of non-refrigerated formulations over traditional refrigerated counterparts exists, ongoing production efficiencies and biosimilar entries are likely to exert downward pressure on prices. Reimbursement policies, especially in health systems emphasizing cost-efficiency, will influence net revenue margins.

Market Entry Barriers and Opportunities

High barriers include clinical trial requirements and regulatory approval processes, especially for biosimilars. However, patent expirations and technological innovation open opportunities for generic and biosimilar manufacturers. Strategic partnerships and licensing agreements serve as pathways to accelerate market access.

Risks and Challenges

Price erosion due to biosimilar competition poses a key risk. Additionally, price regulations in various jurisdictions may limit revenue growth. Manufacturing complexities and patent litigations could delay product launches, impacting income streams.

Market Forecast and Future Outlook

The non-refrigerated DDAVP market is poised for steady growth, underpinned by global healthcare infrastructure expansion and technological innovations. The trend towards decentralized healthcare delivery and home-based therapies boosts demand for stable, easy-to-administer formulations. Emerging markets, notably India and Southeast Asia, are expected to be significant growth vectors owing to the reduced logistical costs and increasing disease awareness.

Key Drivers

• Increased global diagnosis of diabetes insipidus and bleeding disorders.
• Regulatory acceptance and approval of stable, non-refrigerated formulations.
• Advancements in formulation technology extending product shelf life.
• Growing demand in emerging markets due to logistical advantages.
• Enhanced patient compliance and convenience.

Key Challenges

• Patent expirations leading to biosimilar competition.
• Price regulation and reimbursement constraints.
• Manufacturing complexities for biosimilars.
• Regulatory hurdles in different markets.

Conclusion

The financial trajectory of DDAVP, particularly in its non-refrigerated form, is robust, punctuated by innovation-driven supply chain efficiencies, expanding indications, and burgeoning markets. Stakeholders capable of navigating regulatory landscapes, leveraging technological advancements, and optimizing pricing strategies will position themselves advantageously.

---

Key Takeaways

• Strategic Differentiation: Non-refrigerated DDAVP offers a competitive edge through logistical convenience, enabling expansion into emerging markets with limited cold chain capacity.
• Market Growth: Projected CAGR of 4-6% reflects consistent demand driven by new indications, increasing awareness, and healthcare infrastructure expansion.
• Competitive Dynamics: Patent expirations and biosimilar entries will heighten price competition, requiring robust branding and portfolio management.
• Innovation Importance: Ongoing formulation improvements and stability enhancements are critical for maintaining market position.
• Regulatory Navigation: Efficient approval processes and compliance will dictate market access speed and profitability.

---

FAQs

1. What distinguishes non-refrigerated DDAVP formulations from traditional versions?
   Non-refrigerated DDAVP formulations are stabilized to maintain efficacy at room temperature, eliminating cold chain dependence, thereby simplifying logistics, reducing costs, and increasing accessibility, especially in resource-limited settings.

2. How does non-refrigeration impact market growth?
   The stability at ambient temperatures facilitates broader distribution, lowers logistical barriers, and accelerates adoption in emerging markets, directly contributing to market expansion and higher sales volumes.

3. What are the main challenges facing DDAVP manufacturers?
   Challenges include intellectual property expirations leading to biosimilar competition, regulatory hurdles across jurisdictions, manufacturing complexities of biosimilar versions, and price regulation pressures.

4. Which regions are expected to drive future growth?
   Emerging markets in Asia-Pacific, Latin America, and Africa are anticipated to be primary growth drivers due to expanding healthcare infrastructure and previous logistical limitations overcome by non-refrigerated formulations.

5. What technological advances are influencing the DDAVP market?
   Innovations like lyophilization, microencapsulation, and advanced stabilization techniques have enhanced product shelf life, enabled smoother regulatory approvals, and allowed for cost-effective manufacturing, shaping the market's evolution.

---

Sources
[1] IQVIA, Global Pharmaceutical Market Data, 2022.
[2] MarketWatch, "Desmopressin (DDAVP) Market Report," 2023.