DESMOPRESSIN ACETATE - Generic Drug Details

What are the generic drug sources for desmopressin acetate and what is the scope of freedom to operate?

Desmopressin acetate is the generic ingredient in eleven branded drugs marketed by Ferring Pharms Inc, Am Regent, Bedford, Dr Reddys, Gland, Gland Pharma Ltd, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Ferring, Sun Pharm Inds, Bausch, Apotex, Sun Pharm, Zydus Pharms, Acerus Pharms, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, and Novast Labs, and is included in thirty-six NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Desmopressin acetate has two hundred and ten patent family members in thirty-six countries.

There are thirteen drug master file entries for desmopressin acetate. Twenty-seven suppliers are listed for this compound.

Summary for DESMOPRESSIN ACETATE

International Patents:	210
US Patents:	9
Tradenames:	11
Applicants:	27
NDAs:	36
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	10
Patent Applications:	6,922
Drug Prices:	Drug price trends 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
Cairo University	N/A
Genentech, Inc.	Phase 4
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
Bedford	DESMOPRESSIN ACETATE PRESERVATIVE FREE	desmopressin acetate	INJECTABLE;INJECTION	074574-001	Feb 18, 2000		DISCN	No	No
Ubi	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	210223-001	Sep 17, 2020	AP	RX	No	No
Bedford	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	074575-001	Feb 18, 2000		DISCN	No	No
Bausch	DESMOPRESSIN ACETATE	desmopressin acetate	SPRAY, METERED;NASAL	074830-001	Jan 25, 1999	AB	RX	No	Yes
Ubi	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	210218-001	Feb 14, 2020	AP	RX	No	No
Apotex Inc	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	077414-002	Mar 7, 2006	AB	RX	No	No

Expired US Patents for DESMOPRESSIN ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995
Ferring	DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	021795-002	May 8, 2008
Ferring Pharms Inc	DDAVP	desmopressin acetate	SPRAY, METERED;NASAL	017922-002	Feb 6, 1989
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018

International Patents for DESMOPRESSIN ACETATE

Country	Patent Number	Title	Estimated Expiration
Poland	375497	Desmopresyna w ulegającej rozproszeniu w jamie ustnej postaci dawkowanej (DESMOPRESSIN IN AN ORODISPERSIBLE DOSAGE FORM)
Singapore	10201509152V	INTRANASAL DESMOPRESSIN ADMINISTRATION
China	1981745	Pharmaceutical formulations
South Africa	201105420	INTRANASAL DESMOPRESSIN ADMINISTRATION
European Patent Office	2296686	DESMOPRESSINE ORODISPERSIBLE AUGMENTANT LA PÉRIODE INITIALE DE SOMMEIL NON PERTURBÉ PAR LA NYCTURIE (ORODISPERSIBLE DESMOPRESSIN FOR INCREASING INITIAL PERIOD OF SLEEP UNDISTURBED BY NOCTURIA)
European Patent Office	3278809	ADMINISTRATION SÛRE DE DESMOPRESSINE (SAFE DESMOPRESSIN ADMINISTRATION)

Supplementary Protection Certificates for DESMOPRESSIN ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3225249	300983	Netherlands		PRODUCT NAME: DESMOPRESSIN, DESGEWENST IN DE VORM VAN EEN ACETAAT ZOUT; REGISTRATION NO/DATE: BE497271 & BE497280 20160513
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	PA2017001	Lithuania		PRODUCT NAME: DESMOPRESINAS ARBA JO ACETATO DRUSKA; REGISTRATION NO/DATE: BE497271, 2016-05-04; LT1-16/3940/001-LT/1 6/3940/008
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	2019C/520	Belgium		PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513

DESMOPRESSIN ACETATE Market Analysis and Financial Projection Experimental

Global Desmopressin Acetate Market: A Comprehensive Overview

Introduction to Desmopressin Acetate

Desmopressin acetate, a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), is an antidiuretic hormone that plays a crucial role in renal water conservation. It is widely used to treat various polyuric conditions, including nocturia, primary nocturnal enuresis, diabetes insipidus, and other disorders characterized by excessive thirst and urination.

Market Dynamics

Drivers of Market Growth

The global desmopressin acetate market is driven by several key factors:

• Rising Prevalence of Diabetes Insipidus and Other Conditions: The increasing incidence of diabetes insipidus and nocturnal polyuria among the global population is a significant driver. The number of people suffering from these conditions has been on the rise, creating a substantial demand for desmopressin acetate[3][4].
• Government Initiatives and Awareness: Government programs and initiatives aimed at increasing awareness and treatment of diabetes and related conditions have also contributed to the market's growth[3].
• Advancements in Healthcare Infrastructure: The expansion of healthcare infrastructure, particularly in developing regions, has improved access to desmopressin acetate, further boosting market growth[3].

Restraints and Challenges

Despite the positive drivers, the market faces several challenges:

• Adverse Effects: Heavy dosages of desmopressin acetate can lead to side effects such as transient headache, flushing, nausea, and mild abdominal cramps, which can deter some patients and healthcare providers[1][4].
• Alternative Treatment Options: The availability of alternative medicines and therapies, such as factor replacement therapies, can compete with desmopressin acetate and impact its market share[5].
• Regulatory Hurdles: Stringent regulatory requirements and the need for continuous approvals can slow down market growth and increase operational costs for manufacturers[3].

Market Opportunities

Several opportunities are emerging in the desmopressin acetate market:

• Research and Development: Ongoing R&D activities focused on developing new formulations, such as once-nightly dosages and novel drug delivery technologies, are expected to enhance drug efficacy and patient adherence[2][4].
• Expanding into Developing Regions: Improving healthcare access in developing regions presents a significant opportunity for market expansion[3].
• Investments by Market Players: Increasing investments by pharmaceutical companies, such as Amring Pharmaceuticals, to improve product quality and customer service are driving market growth[1][4].

Financial Trajectory

Current Market Size and Growth

The desmopressin acetate market has shown steady growth over recent years. As of 2022, the market was valued at approximately USD 1.055 billion and is projected to grow to USD 1.657 billion by 2030, with a Compound Annual Growth Rate (CAGR) of around 5.8% during the forecast period of 2023-2030[4].

Regional Performance

• North America: This region dominates the market due to the presence of key manufacturers and high research and development activities. The U.S. and Canada are the leading countries in this region[1][4].
• Asia Pacific: This region is expected to experience the highest growth rate during the forecast period, driven by new research and developments in the desmopressin market, particularly in countries like India, China, and Japan[4].

Key Market Players

The market is competitive, with several key players focusing on research and development, strategic partnerships, and expanding their product portfolios:

• Pfizer: Known for its extensive pharmaceutical portfolio.
• Teva: Relaunched its Desmopressin Acetate Injection Solution in 2019 after a hiatus since 2012[1].
• Avadel Pharmaceuticals: Commercially launched Noctiva™, the first FDA-approved formulation of desmopressin acetate for nocturia, in 2018[2].
• Amring Pharmaceuticals: Announced investments in desmopressin acetate to provide high-quality generic medications[1].

Product Forms and Applications

Desmopressin acetate is available in various forms, including:

• Injectable Solution: Used for severe cases and in hospital settings.
• Nasal Spray: Commonly used for nocturnal enuresis and diabetes insipidus.
• Tablets: Oral administration for conditions like nocturia and primary nocturnal enuresis[4].

The drug is applied across different age groups, including pediatric and geriatric populations, and is distributed through various channels such as hospital pharmacies, online pharmacies, and retail pharmacies[4].

Regulatory Landscape

The market is heavily influenced by regulatory approvals and compliance. For instance, the FDA approval of new formulations and the registration of outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act are crucial for market growth[5].

Future Outlook

The desmopressin acetate market is poised for continued growth, driven by increasing awareness of related conditions, advancements in drug delivery technologies, and expanding healthcare infrastructure. However, manufacturers must navigate the challenges of adverse effects, regulatory hurdles, and competition from alternative treatments.

"Desmopressin acetate is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone that affects renal water conservation." - Transparency Market Research[1]

Key Takeaways

• The desmopressin acetate market is driven by the rising prevalence of diabetes insipidus and other polyuric conditions.
• North America currently leads the market, but the Asia Pacific region is expected to show the highest growth rate.
• The market faces challenges such as adverse effects and competition from alternative treatments.
• Ongoing R&D and investments by market players are key to future growth.
• The market is expected to grow at a CAGR of around 5.8% from 2023 to 2030.

FAQs

What are the primary uses of desmopressin acetate?

Desmopressin acetate is primarily used to treat conditions such as nocturia, primary nocturnal enuresis, diabetes insipidus, and other polyuric conditions.

Which region dominates the desmopressin acetate market?

North America currently dominates the desmopressin acetate market, with the U.S. and Canada being the leading countries.

What are the main challenges facing the desmopressin acetate market?

The main challenges include adverse effects associated with the drug, competition from alternative treatments, and stringent regulatory hurdles.

Who are the key players in the desmopressin acetate market?

Key players include Pfizer, Teva, Avadel Pharmaceuticals, and Amring Pharmaceuticals.

What is the projected growth rate of the desmopressin acetate market?

The market is projected to grow at a CAGR of around 5.8% from 2023 to 2030.

Sources

1. Biospace: Desmopressin Acetate Market: Rising prevalence of diabetes to drive the market[1].
2. Avadel Pharmaceuticals: Avadel Pharmaceuticals Issues 2018 Corporate Outlook[2].
3. Research and Markets: Desmopressin Market Size, Competitors & Forecast to 2030[3].
4. Data Bridge Market Research: Desmopressin Market Size, Outlook, Trends, Report | Forecast 2030[4].
5. National Bleeding Disorders Foundation: Latest Updates on Generic Desmopressin Product[5].