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-seven 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:	18
Clinical Trials:	23
Patent Applications:	5
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
Naval Medical Center Camp Lejeune	Phase 3
Providence Hospital	Phase 1/Phase 2
Kingston Health Sciences Centre	Phase 1/Phase 2

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	5,763,407
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996	5,482,931
Ferring Pharms Inc	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	SPRAY, METERED;NASAL	017922-003	Aug 7, 1996	5,674,850

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
Italy	1056718	PROCESSO PER LA PRODUZIONE DI UN POLIPEPTIDE AD AZIONE ANTIDIURETICA
Greece	3036936
Spain	2168301

Supplementary Protection Certificates for DDAVP (NEEDS NO REFRIGERATION)

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
3225249	2019C/520	Belgium		PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND 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

DDAVP (NEEDS NO REFRIGERATION) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of DDAVP (Desmopressin Acetate)

Introduction to DDAVP

DDAVP, or desmopressin acetate, is a synthetic analogue of the natural hormone vasopressin. It is widely used to treat various medical conditions, including diabetes insipidus, nocturnal polyuria, hemophilia A, and von Willebrand disease. Here, we delve into the market dynamics and financial trajectory of DDAVP.

Market Size and Forecast

The desmopressin market, which includes DDAVP, has been experiencing significant growth. As of 2022, the market was valued at USD 1,055.63 million and is projected to grow to USD 1,657.28 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period of 2023-2030[1][4].

Drivers of Market Growth

Growing Prevalence of Diabetes

The increasing prevalence of diabetes is a major driver for the desmopressin market. Between 1980 and 2014, the number of people suffering from diabetes rose from 108 million to 422 million, with a significant increase in low and middle-income countries. This rise in diabetes cases, along with associated kidney diseases, has led to an increased demand for desmopressin[1].

Increased Awareness About Diseased Conditions

Enhanced research and awareness campaigns about conditions such as nocturnal polyuria and bedwetting in children have contributed to the market's expansion. The adoption of clinical drugs for these conditions, coupled with counseling sessions, has further boosted the market's growth rate[1].

Investments by Market Players

Several pharmaceutical companies have been investing heavily in the development and marketing of desmopressin acetate. For instance, Ferring Pharmaceuticals acquired the marketing rights for DDAVP from Sanofi in 2014, demonstrating a commitment to supporting disorders with high unmet medical needs[2].

Forms and Applications of DDAVP

DDAVP is available in various formulations, including tablets, nasal sprays, rhinal tubes, and injectable solutions. These diverse forms cater to different patient needs and conditions, such as:

• Diabetes Insipidus: DDAVP helps regulate water balance in the body.
• Nocturnal Polyuria: It reduces nighttime urination.
• Hemophilia A and von Willebrand Disease: DDAVP boosts factor VIII and von Willebrand factor levels to treat bleeding disorders[2][5].

End-Users and Distribution Channels

The desmopressin market serves a range of end-users, including hospitals, homecare settings, specialty clinics, and others. The distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies. The presence of key manufacturers in North America and increasing research activities in this region have made it a dominant market for desmopressin[1].

Regional Analysis

Asia-Pacific

The Asia-Pacific region is expected to see the highest growth in the desmopressin market due to new research and developments. This growth is driven by increasing awareness and the need for effective treatments for conditions like diabetes insipidus and bleeding disorders[1].

North America

North America currently dominates the market due to the presence of major manufacturers and ongoing research and development activities. Ferring Pharmaceuticals, for example, has a significant presence in this region and continues to invest in the development of desmopressin products[1][2].

Challenges and Restraints

Side-Effects of Desmopressin

Despite its benefits, desmopressin can cause side-effects such as flushing, nausea, transient headaches, and mild abdominal cramps, especially with heavy dosages. These side-effects can hinder market growth by deterring some patients from using the drug[1].

Manufacturing and Supply Issues

In recent years, there have been manufacturing issues that affected the supply of desmopressin products. For instance, Ferring Pharmaceuticals suspended the production of the nasal spray STIMATE® in 2020 due to a packaging seal issue, leading to a temporary shortage and the need for alternative treatments[5].

Generic Desmopressin Products

The introduction of generic desmopressin products has been a significant development. In 2021, STAQ Pharma began manufacturing a generic desmopressin-based nasal spray to fill the gap created by the suspension of STIMATE®. This move has helped in making the drug more accessible and affordable for patients[5].

Financial Trajectory

The financial trajectory of the desmopressin market is positive, with a projected CAGR of 5.8% from 2023 to 2030. Here are some key financial highlights:

• Market Value in 2022: USD 1,055.63 million
• Projected Market Value by 2030: USD 1,657.28 million
• CAGR: 5.8% during the forecast period[1][4].

Key Takeaways

• The desmopressin market, driven by the growing prevalence of diabetes and increased awareness of treated conditions, is expected to grow significantly.
• Diverse formulations of DDAVP cater to various medical needs.
• North America and Asia-Pacific are key regions driving market growth.
• Despite challenges such as side-effects and manufacturing issues, the market is poised for continued expansion.
• The introduction of generic products is enhancing accessibility and affordability.

FAQs

What are the primary uses of DDAVP?

DDAVP is used to treat conditions such as diabetes insipidus, nocturnal polyuria, hemophilia A, and von Willebrand disease.

Who are the major players in the desmopressin market?

Major players include Ferring Pharmaceuticals, which acquired the marketing rights for DDAVP from Sanofi in 2014.

What are the different forms of DDAVP available?

DDAVP is available in tablets, nasal sprays, rhinal tubes, and injectable solutions.

What are the challenges facing the desmopressin market?

Challenges include side-effects of the drug and manufacturing issues that have led to temporary shortages.

How is the desmopressin market expected to grow in the future?

The market is expected to grow at a CAGR of 5.8% from 2023 to 2030, reaching a projected value of USD 1,657.28 million by 2030.

Sources

1. Data Bridge Market Research: Global Desmopressin Market Size, Outlook, Trends, Report | Forecast 2030.
2. FiercePharma: Ferring Pharmaceuticals to acquire marketing rights for DDAVP® (desmopressin acetate) product.
3. Aos Pares: Causas que nos tocam!
4. Verified Market Research: In-Depth Industry Outlook: Desmopressin Market Size & Forecast.
5. NBDF: Latest Updates on Generic Desmopressin Product.