DESMOPRESSIN ACETATE Drug Patent Profile

Which patents cover Desmopressin Acetate, and what generic alternatives are available?

Desmopressin Acetate is a drug marketed by Am Regent, Bedford, Dr Reddys, Gland, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Sun Pharm Inds, Bausch, Abhai Llc, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Ferring, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, Novast Labs, Sun Pharm, and Zydus Pharms. and is included in twenty-eight NDAs.

The generic ingredient in DESMOPRESSIN ACETATE 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 Desmopressin Acetate

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

Summary for DESMOPRESSIN ACETATE

US Patents:	0
Applicants:	23
NDAs:	28
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	230
Drug Prices:	Drug price information for DESMOPRESSIN ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESMOPRESSIN ACETATE
What excipients (inactive ingredients) are in DESMOPRESSIN ACETATE?	DESMOPRESSIN ACETATE excipients list
DailyMed Link:	DESMOPRESSIN ACETATE at DailyMed

See drug prices for DESMOPRESSIN ACETATE

Recent Clinical Trials for DESMOPRESSIN ACETATE

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

Sponsor	Phase
Xing Liu	NA
Cairo University	N/A
Indiana Hemophilia &Thrombosis Center, Inc.	Phase 4

See all DESMOPRESSIN ACETATE clinical trials

Pharmacology for DESMOPRESSIN ACETATE

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

Anatomical Therapeutic Chemical (ATC) Classes for DESMOPRESSIN ACETATE

H01BA	Vasopressin and analogues
H01B	POSTERIOR PITUITARY LOBE HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for DESMOPRESSIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco Pharma Usa	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	200653-002	Jun 27, 2014		DISCN	No	No
Heritage Pharma	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	207880-002	May 26, 2017	AB	RX	No	No
Novast Labs	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	208357-001	Jun 6, 2019	AB	RX	No	No
Impax Labs Inc	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	077122-001	Jan 25, 2006		DISCN	No	No
Am Regent	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091374-001	Feb 14, 2019		DISCN	No	No

Expired US Patents for DESMOPRESSIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-001	May 8, 2008	7,022,340
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-002	May 8, 2008	7,022,340

International Patents for DESMOPRESSIN ACETATE

See the table below for patents covering DESMOPRESSIN ACETATE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2490335	COMPOSITION PHARMACEUTIQUE DE FORME SOLIDE, ET METHODE DE FABRICATION CONNEXE (PHARMACEUTICAL COMPOSITION AS SOLID DOSAGE FORM AND METHOD FOR MANUFACTURING THEREOF)
New Zealand	544104	Pharmaceutical desmopressin composition as solid dosage form and method for manufacturing thereof
Austria	301990
Slovenia	1500390
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)

Supplementary Protection Certificates for DESMOPRESSIN ACETATE

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	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 Desmopressin Acetate

Last updated: July 27, 2025

Introduction

Desmopressin acetate, a synthetic analogue of the natural hormone vasopressin, is a cornerstone in managing conditions such as diabetes insipidus, bedwetting (primary nocturnal enuresis), and certain bleeding disorders like von Willebrand disease. As a well-established medication, it continues to hold strategic importance within the pharmaceutical landscape. Understanding the market dynamics and financial trajectory of desmopressin acetate requires an analysis of current medical needs, regulatory environment, competitive landscape, and technological trends.

Market Overview

Global Market Size and Growth Trends

The global desmopressin market was valued at approximately USD 1.4 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4-5% through 2030, driven by increasing prevalence of target conditions and expanding indications. The growth is further influenced by the rising awareness among healthcare providers and patients, as well as the geographical expansion into emerging markets where healthcare infrastructure is improving.

Key Indications and Drivers

• Diabetes insipidus (DI): Desmopressin remains the primary treatment, with chronic management requirements supporting consistent demand.
• Bleeding disorders: Increased use in von Willebrand disease and mild hemophilia, especially as personalized medicine advances.
• Enuresis: Off-label and on-label use in pediatric and adult primary nocturnal enuresis, with particular focus in adolescent populations.

Prevalence and Demographic Factors

The rising incidence of diabetes insipidus, especially among pediatric populations, and growing awareness of enuresis therapies substantially propel market demand. The aging global population, coupled with a rise in chronic kidney and bleeding disorders, further sustains the market growth trajectory.

Market Dynamics

Regulatory Environment

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) maintain strict standards for efficacy and safety. While desmopressin formulations are generally well-established, recent regulatory focus on formulation consistency, bioequivalence, and manufacturing quality controls influences market availability.

Patent expirations of older formulations have opened the market for generic versions, intensifying price competition but also expanding access, especially in price-sensitive regions. Notably, the expiry of certain branded patents in North America and Europe has led to increased availability of cost-effective generics, impacting overall market revenue streams.

Competitive Landscape

Mainstream pharmaceutical firms such as Ferring Pharmaceuticals, Evofarm, and Boehringer Ingelheim dominate the market with established brands like Minirin and Desmoctol. Generic manufacturers are entering various markets, placing downward pressure on prices. The competitive positioning hinges on factors such as formulation innovations (e.g., nasal spray versus injectable), delivery mechanisms, and regional distribution networks.

Emerging biosimilar and novel delivery system developments pose potential disrupters. For instance, microdose nasal sprays and long-acting formulations aim to improve compliance and therapeutic outcomes, thereby influencing market dynamics favorably.

Patents and Intellectual Property

Patents primarily safeguard key formulations and delivery devices. The expiration of patents exemplifies a pivotal turning point, as seen with nasal spray formulations in the United States (e.g., 2015 for some desmopressin products), leading to a proliferation of generics. Patent cliffs can catalyze both revenue decline for branded manufacturers and opportunities for cost reductions.

Technological Innovations

Advancements include sustained-release delivery systems, needle-free injection devices, and novel nasal spray technologies that improve bioavailability, ease of use, and patient adherence. These innovations add competitive differentiation, influencing market share and financial forecasts.

Financial Trajectory

Revenue Generation and Pricing Trends

Branded versions of desmopressin historically commanded premium pricing. Post-patent expiration, the commoditization via generics has driven prices downward in mature markets, averaging a 30-50% reduction, fostering increased accessibility but impacting revenue streams for manufacturers holding exclusive rights.

Market Segmentation and Regional Influence

• North America: Largest market share, driven by high diagnosis rates and advanced healthcare infrastructure. However, price sensitivity and evolving generic landscape pressure margins.
• Europe: Mature market with strong regulation complementing steady demand; generics significantly influence market share.
• Asia-Pacific: Fastest-growing segment, with increasing prevalence of target conditions, expanding healthcare access, and less stringent price controls fostering a lucrative growth opportunity.
• Emerging Markets: Oil for growth amid rising middle class, improving health awareness, and expanding infrastructure.

Forecasting and Revenue Projections

Conservative estimates suggest a stabilization of revenues in established markets, with growth predominantly fueled by volume increases in emerging regions. Innovations in delivery modalities and potential new indications, like adjunct therapy in diabetes management, could catalyze revenue expansion.

Market Challenges and Opportunities

Challenges

• Generic Competition: Greatly influences pricing strategies, especially post-patent expiry.
• Regulatory Hurdles: Differing regional approval pathways and strict quality controls can hinder rapid market entry.
• Market Saturation: Mature markets approaching saturation levels, requiring innovation or new indications to sustain growth.
• Patient Adherence: Complex dosing regimens and side effect management impact real-world efficacy.

Opportunities

• Novel Delivery Platforms: Microdosing nasal sprays and long-acting injectables to improve compliance and expand indications.
• Expansion into New Markets: Increasing healthcare investments in emerging regions.
• Personalized Medicine: Genetic profiling to predict response and optimize therapy.
• Off-Label and Adjunct Uses: Exploring novel therapeutic applications may unlock new revenue streams.

Regulatory and Patent Landscape

Patent expirations have historically driven market expansion through generics, though innovator firms continue to seek new patents around delivery systems and formulations. Regulatory pathways are evolving to accommodate biosimilars and combination therapies, providing avenues for product differentiation.

Conclusion

The financial future of desmopressin acetate hinges on navigating patent expirations, embracing technological innovations, and capturing growth in emerging markets. While traditional revenue sources face challenges from generic competition, strategic investments in advanced delivery systems and expanding indications can foster resilience and growth. The interplay of regulatory shifts and technological developments will shape the competitive landscape, necessitating agility from market participants.

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Key Takeaways

• The desmopressin market is poised for steady growth, driven by rising prevalence of target conditions and demographic shifts.
• Patent expirations have resulted in increased generic competition, exerting pressure on prices and margins but expanding access.
• Technological innovations in delivery systems present significant opportunities for differentiation and market expansion.
• Emerging markets offer substantial growth prospects owing to healthcare infrastructure improvements and increasing awareness.
• Strategic focus on formulation innovation, regional expansion, and new therapeutic applications will be critical for sustained financial performance.

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FAQs

1. What are the primary factors influencing the market growth of desmopressin acetate?
   Increasing prevalence of conditions treated by desmopressin, demographic shifts, technological innovations, and expanding healthcare access in emerging markets drive growth.

2. How do patent expirations impact desmopressin manufacturers?
   Patent expirations lead to generic market entry, reducing prices and profit margins for branded products while increasing overall market accessibility.

3. What technological advancements are shaping the future of desmopressin delivery?
   Innovations include microdose nasal sprays, long-acting injectables, and needle-free devices, aimed at improving patient adherence and therapeutic efficacy.

4. Which regions present the most significant opportunities for growth?
   The Asia-Pacific region offers rapid growth opportunities, thanks to rising healthcare investments, increasing disease awareness, and expanding infrastructure.

5. Are there emerging therapeutic indications for desmopressin beyond current uses?
   Research is ongoing into new indications such as adjunctive therapy in diabetes management and potential off-label applications, which could unlock additional revenue streams.

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Sources
[1] Market Research Future. "Desmopressin Market Forecast to 2030."
[2] Grand View Research. "Global Desmopressin Market Analysis."
[3] FDA and EMA official documents on desmopressin regulatory status.