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Last Updated: December 21, 2024

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) Drug Patent Profile


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When do Desmopressin Acetate (needs No Refrigeration) patents expire, and what generic alternatives are available?

Desmopressin Acetate (needs No Refrigeration) is a drug marketed by Apotex, Sun Pharm, and Zydus Pharms. and is included in three NDAs.

The generic ingredient in DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) 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 Desmopressin Acetate (needs No Refrigeration)

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

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Summary for DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Drug patent expirations by year for DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Pharmacology for DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

US Patents and Regulatory Information for DESMOPRESSIN ACETATE (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
Apotex DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 076703-001 Jan 27, 2005 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 078271-001 Dec 23, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) desmopressin acetate SPRAY, METERED;NASAL 091345-001 Oct 3, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) Market Analysis and Financial Projection Experimental

Desmopressin Acetate Market Dynamics and Financial Trajectory

Introduction to Desmopressin Acetate

Desmopressin acetate is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone that affects renal water conservation. It is widely used in treating various conditions such as diabetes insipidus, nocturnal enuresis, hemophilia A, von Willebrand disease, and nocturia[3][4][5].

Market Size and Growth Projections

The desmopressin acetate market has been experiencing significant growth, driven by the increasing prevalence of conditions it treats. As of 2023, the market size was valued at USD 100 billion and is projected to reach USD 147.74 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Key Drivers of Market Growth

Rising Prevalence of Target Conditions

The market is largely driven by the growing prevalence of diabetes insipidus, hemophilia A, and nocturnal enuresis. These conditions are becoming more common, leading to an increased demand for effective treatments like desmopressin acetate[1][4][5].

Advancements in Drug Formulations

Novel formulations such as oral tablets, nasal sprays, and sublingual tablets have improved patient compliance and expanded the market. These user-friendly delivery systems make the treatment more accessible and convenient for patients[1][5].

Expanding Therapeutic Applications

Research into new therapeutic applications of desmopressin acetate is also driving market growth. For instance, the FDA approval of Noctiva for the treatment of nocturia due to nocturnal polyuria has opened up new market opportunities[2].

Global Healthcare Infrastructure Advancements

Improvements in healthcare infrastructure, particularly in emerging economies, have created a favorable environment for the growth of the desmopressin acetate market. Increased investments in healthcare by governments and private players are supporting this trend[5].

Geographical Market Distribution

North America and Europe

These regions are currently the leading markets for desmopressin acetate due to advanced healthcare infrastructure and high awareness of the drug's benefits. Countries like the U.S. and Canada in North America, and key European nations, are at the forefront of this market[4][5].

Asia-Pacific and Latin America

Emerging economies in these regions are witnessing rapid growth due to increasing healthcare investments and improving diagnostic practices. India, China, and Japan are significant contributors to the growth in the Asia-Pacific region[4][5].

Market Segmentation

The desmopressin acetate market is segmented based on application (tablets, nasal spray, injectable, sublingual tablets, oral solution) and product (diabetes insipidus, bedwetting, hemophilia A, von Willebrand disease, nocturia)[1].

Key Players and Competitive Landscape

Major players in the global desmopressin acetate market include Pfizer, Teva, Northstar Rx, and Blue Point Laboratories. These companies are focusing on research and development to enhance their market presence and are engaging in strategic partnerships to expand their reach[4].

Challenges and Opportunities

Regulatory Hurdles

Navigating stringent regulatory frameworks remains a significant challenge for companies in the desmopressin acetate market. Ensuring compliance with evolving safety and efficacy standards is crucial for maintaining market presence[5].

Supply Chain Disruptions

Global disruptions, such as those seen during the COVID-19 pandemic, have highlighted the need for resilient supply chains. Manufacturers are investing in localized production to mitigate risks and ensure uninterrupted availability of the drug[5].

Cost-Effective Manufacturing

The shift towards generic versions of desmopressin acetate has made treatment more affordable, increasing its accessibility in lower-income regions. However, the need for cost-effective manufacturing to meet demand in these regions remains a challenge[5].

Financial Projections and Revenue Potential

Revenue Estimates

Avadel Pharmaceuticals, for instance, estimates that peak revenues for Noctiva, a desmopressin acetate formulation, could be as high as $750 million or more per year[2].

Total Revenues

The overall market is expected to generate significant revenues, with total revenues for companies like Avadel Pharmaceuticals projected to range from $110 to $130 million in certain years[2].

Impact of Innovations

Extended-Release Formulations

Recent innovations include extended-release formulations that improve patient compliance and reduce the frequency of dosing. These advancements are driving the market forward by offering more convenient treatment options[5].

User-Friendly Delivery Systems

Nasal sprays and melt-in-mouth tablets are examples of user-friendly delivery systems that have enhanced the market. These formulations make the treatment more accessible and improve patient adherence to the medication regimen[5].

Key Takeaways

  • The desmopressin acetate market is projected to grow significantly, driven by the increasing prevalence of target conditions and advancements in drug formulations.
  • The market is expected to reach USD 147.74 billion by 2031, growing at a CAGR of 5% from 2024 to 2031.
  • North America and Europe are the leading markets, with emerging economies in Asia-Pacific and Latin America showing rapid growth.
  • Key players are focusing on research and development and strategic partnerships to enhance their market presence.
  • Regulatory hurdles, supply chain disruptions, and the need for cost-effective manufacturing are significant challenges.

FAQs

Q: What is desmopressin acetate used for? A: Desmopressin acetate is used to treat conditions such as diabetes insipidus, nocturnal enuresis, hemophilia A, von Willebrand disease, and nocturia.

Q: What is the projected market size of desmopressin acetate by 2031? A: The desmopressin acetate market is expected to reach USD 147.74 billion by 2031.

Q: Which regions are leading the desmopressin acetate market? A: North America and Europe are currently the leading markets, with significant growth also seen in emerging economies in Asia-Pacific and Latin America.

Q: What are the key drivers of the desmopressin acetate market? A: The key drivers include the rising prevalence of target conditions, advancements in drug formulations, and improvements in global healthcare infrastructure.

Q: What challenges does the desmopressin acetate market face? A: The market faces challenges such as regulatory hurdles, supply chain disruptions, and the need for cost-effective manufacturing to meet demand in low-income regions.

Cited Sources

  1. Market Research Intellect - Desmopressin Acetate Market Size, Share & Trends [2031]
  2. Avadel Pharmaceuticals plc - Avadel Pharmaceuticals Issues 2018 Corporate Outlook
  3. PubChem - Desmopressin Acetate
  4. BioSpace - Desmopressin Acetate Market: Rising prevalence of diabetes to drive the market
  5. Market Research Intellect - Desmopressin Acetate Market Expands with Growing Diabetes Insipidus Treatments

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