DULOXETINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for duloxetine hydrochloride and what is the scope of patent protection?

Duloxetine hydrochloride is the generic ingredient in three branded drugs marketed by Lilly, Sun Pharm, Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Endo Operations, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Prinston Inc, Qingdao Baheal Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Duloxetine hydrochloride has one patent family member in one country.

There are forty drug master file entries for duloxetine hydrochloride. Fifty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for DULOXETINE HYDROCHLORIDE

International Patents:	1
US Patents:	4
Tradenames:	3
Applicants:	24
NDAs:	25
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	356
Patent Applications:	677
What excipients (inactive ingredients) are in DULOXETINE HYDROCHLORIDE?	DULOXETINE HYDROCHLORIDE excipients list
DailyMed Link:	DULOXETINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DULOXETINE HYDROCHLORIDE

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

Sponsor	Phase
National Cancer Institute, Egypt	Phase 4
Beni-Suef University	Phase 2
Institut Cancerologie de l'Ouest	Phase 3

See all DULOXETINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DULOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 60MG BASE	CAPSULE, DELAYED RELEASE; ORAL
		EQ 30MG BASE	CAPSULE, DELAYED RELEASE; ORAL
		EQ 20MG BASE	CAPSULE, DELAYED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DULOXETINE HYDROCHLORIDE

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for DULOXETINE HYDROCHLORIDE

Analgesics

Antidepressive Agents

Dopamine Agents

Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DULOXETINE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DULOXETINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CYMBALTA	Delayed-release Capsules	duloxetine hydrochloride	40 mg	021427	1	2012-05-10
CYMBALTA	Delayed-release Capsules	duloxetine hydrochloride	20 mg, 30 mg and 60 mg	021427	16	2008-08-04

US Patents and Regulatory Information for DULOXETINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516-003	Jul 19, 2019		RX	Yes	No			Y
Zydus Pharms	DULOXETINE HYDROCHLORIDE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	090728-002	Jan 8, 2014	AB	RX	No	No
Sun Pharm	DULOXETINE HYDROCHLORIDE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	090745-001	Dec 11, 2013	AB	RX	No	No
Prinston Inc	DULOXETINE HYDROCHLORIDE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	206653-001	May 18, 2017	AB	RX	No	No
Qingdao Baheal Pharm	DULOXETINE HYDROCHLORIDE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	210599-002	Apr 17, 2019	AB	RX	No	No

Expired US Patents for DULOXETINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-001	Aug 3, 2004
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004

International Patents for DULOXETINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3335697	ÉCLATS DE DULOXÉTINE (DULOXETINE SPRINKLES)

Supplementary Protection Certificates for DULOXETINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	SPC/GB05/003	United Kingdom		PRODUCT NAME: DULOXETINE AND PHARMACUETICALLY ACCEPTABLE ACID ADDITION SALTS THEREOF, AND IN PARTICULAR DULOXETINE HYDROCHLORIDE; REGISTERED: UK EU/1/04/280/001 20040811; UK EU/1/04/280/002 20040811; UK EU/1/04/280/003 20040811; UK EU/1/04/280/004 20040811; UK EU/1/04/280/005 20040811; UK EU/1/04/280/006 20040811
0273658	C300171	Netherlands		PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
0273658	2005C/001	Belgium		PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811

DULOXETINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Duloxetine Hydrochloride

Market Overview

The duloxetine hydrochloride (HCl) market is a significant segment within the pharmaceutical industry, primarily serving as a treatment for various psychiatric and chronic pain disorders. Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), is indicated for major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathy (DPN), fibromyalgia, and chronic musculoskeletal pain. The market was valued at approximately USD 6.5 billion in 2023 and is projected to reach around USD 11.4 billion by 2033, with a compound annual growth rate (CAGR) of 5.7% from 2024 to 2033[1].

Market Drivers

Several factors drive the growth of the duloxetine HCl market. The rising incidence of psychiatric disorders and chronic pain conditions globally is a significant driver. According to the World Health Organization (WHO), depression affects more than 264 million people worldwide, and chronic pain conditions like diabetic neuropathy and fibromyalgia impose a substantial burden on healthcare systems. Duloxetine HCl's dual mechanism of action, addressing both emotional and physical symptoms, makes it a preferred choice among healthcare providers[1].

Advancements in drug delivery technologies, including extended-release formulations, also contribute to improved patient adherence and treatment outcomes. Growing awareness about mental health and initiatives to reduce stigma associated with psychiatric disorders further drive market growth, expanding the reach of duloxetine HCl in both developed and emerging markets[1].

Regional Analysis

Geographically, North America dominates the duloxetine HCl market, driven by high healthcare expenditure, the prevalence of psychiatric disorders, and the extensive adoption of SNRI therapies. The presence of key pharmaceutical companies and advanced healthcare infrastructure further supports market growth in this region. Europe follows closely, characterized by increasing mental health awareness and favorable reimbursement policies for psychiatric medications[1].

In the Asia-Pacific region, rapid urbanization, improving healthcare access, and growing acceptance of mental health treatments contribute to market expansion opportunities. Latin America and the Middle East & Africa exhibit gradual market growth, driven by improving healthcare infrastructure and initiatives aimed at enhancing mental health services[1].

Competitive Analysis

The competitive landscape of the duloxetine HCl market is highly competitive, involving a mix of multinational pharmaceutical companies and generic manufacturers vying for market share. Key players such as Eli Lilly and Company, Pfizer Inc., and Teva Pharmaceutical Industries Ltd. focus on innovation through new product launches, strategic partnerships, and acquisitions to maintain market leadership. Generic competition exerts significant price pressures, prompting originator companies to invest in lifecycle management strategies and novel drug delivery technologies to differentiate their products[1].

Financial Trajectory

Healthcare Costs and Treatment Outcomes

Studies have shown that the initiation of duloxetine therapy can significantly impact healthcare costs. A retrospective analysis of 10,987 outpatients with major depressive disorder (MDD) revealed that total healthcare costs increased prior to and decreased following the initiation of duloxetine treatment. Patients initiated at high doses (>60 mg/day) had higher costs both prior to and throughout treatment compared to those initiated at lower doses. However, the increased medication costs associated with high-dose therapy were offset by reduced inpatient expenses, making high-dose therapy cost-beneficial for certain patient groups[2].

Market Growth Projections

The duloxetine HCl market is expected to experience robust growth during the forecast period from 2024 to 2033. The market's CAGR of 5.7% is driven by the increasing prevalence of psychiatric disorders, advancements in drug formulations, and growing awareness about mental health. The market size is projected to nearly double from USD 6.5 billion in 2023 to USD 11.4 billion by 2033[1].

Revenue and Exponential Growth

The duloxetine HCl market has encountered rapid and substantial growth in recent years and is expected to continue this trend. Projections indicate a significant expansion from 2023 to 2031, with the market on the brink of noteworthy development. This upward trend in market dynamics suggests strong growth rates in the foreseeable future[4].

Market Segmentation

The duloxetine intermediate market, which includes duloxetine HCl, is segmented based on application and distribution channel. Applications include depressive disorders, anxiety disorders, neuropathic pain, chronic musculoskeletal pain, fibromyalgia, and others. Distribution channels are segmented into hospital pharmacy, online pharmacy, and retail pharmacy. This segmentation helps in understanding the diverse needs and preferences of different patient groups and healthcare providers[3].

Regional Market Size and Forecast

The market size and forecast estimates vary by region. North America, Europe, Asia-Pacific, Middle East & Africa, and South & Central America are the key regions analyzed. Each region is further sub-segmented by country to provide a detailed overview of the market. The report covers analysis and forecast of 18 countries globally, highlighting current trends and opportunities prevailing in each region[3].

Challenges and Opportunities

Despite the growth prospects, the duloxetine HCl market faces challenges such as rising healthcare costs and negative medication price control strategies. However, the high usage of duloxetine intermediates in emerging nations is expected to provide significant opportunities in the global market. The growing significance of generics and the developing predominance of major depressive disorder (MDD) also drive market growth[3].

Key Takeaways

• The duloxetine HCl market is valued at approximately USD 6.5 billion in 2023 and is projected to reach USD 11.4 billion by 2033.
• The market is driven by the high prevalence of psychiatric disorders and chronic pain conditions, advancements in drug formulations, and growing mental health awareness.
• North America dominates the market, followed by Europe and the Asia-Pacific region.
• The competitive landscape is highly competitive, with key players focusing on innovation and lifecycle management strategies.
• Healthcare costs decrease following the initiation of duloxetine therapy, with high-dose therapy being cost-beneficial for certain patient groups.
• The market is segmented by application and distribution channel, with diverse regional market sizes and forecasts.

FAQs

What is the projected market size of duloxetine HCl by 2033?

The duloxetine HCl market is projected to reach around USD 11.4 billion by 2033[1].

What are the primary drivers of the duloxetine HCl market?

The primary drivers include the rising incidence of psychiatric disorders and chronic pain conditions, advancements in drug delivery technologies, and growing awareness about mental health[1].

Which region dominates the duloxetine HCl market?

North America dominates the duloxetine HCl market, driven by high healthcare expenditure and the prevalence of psychiatric disorders[1].

How does the initiation of duloxetine therapy impact healthcare costs?

The initiation of duloxetine therapy can decrease total healthcare costs, with increased medication costs offset by reduced inpatient expenses, especially for patients initiated at high doses[2].

What are the challenges faced by the duloxetine HCl market?

Challenges include rising healthcare costs and negative medication price control strategies, although high usage in emerging nations provides significant opportunities[3].

Sources

1. DataHorizzon Research: "Duloxetine Hcl Market Size, Growth and Analysis Report - 2033"[1]
2. PubMed: "Trajectory analysis of healthcare costs for patients with major depressive disorder initiated on duloxetine"[2]
3. The Insight Partners: "Duloxetine Intermediate Market Dynamics 2021-2031"[3]
4. Market Research Intellect: "Global Duloxetine Hcl Market Size, Trends and Projections"[4]