GUANFACINE HYDROCHLORIDE - Generic Drug Details

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

Guanfacine hydrochloride is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Alembic, Apotex, Impax Labs Inc, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, Yichang Humanwell, Takeda Pharms Usa, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Rubicon, Unichem, Watson Labs, Xiromed, and Promius Pharma, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for guanfacine hydrochloride. Thirty-four suppliers are listed for this compound.

Summary for GUANFACINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	22
NDAs:	24
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	69
Patent Applications:	1,274
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GUANFACINE HYDROCHLORIDE
What excipients (inactive ingredients) are in GUANFACINE HYDROCHLORIDE?	GUANFACINE HYDROCHLORIDE excipients list
DailyMed Link:	GUANFACINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for GUANFACINE HYDROCHLORIDE

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2
Rachel G. Greenberg, MD, MB, MHS	Phase 2
The Emmes Company, LLC	Phase 2

See all GUANFACINE HYDROCHLORIDE clinical trials

Pharmacology for GUANFACINE HYDROCHLORIDE

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for GUANFACINE HYDROCHLORIDE

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for GUANFACINE HYDROCHLORIDE

C02AC	Imidazoline receptor agonists
C02A	ANTIADRENERGIC AGENTS, CENTRALLY ACTING
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

Paragraph IV (Patent) Challenges for GUANFACINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTUNIV	Extended-release Tablets	guanfacine hydrochloride	1 mg, 2 mg, 3 mg and 4 mg	022037	1	2009-12-29

US Patents and Regulatory Information for GUANFACINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202238-003	Oct 20, 2015		DISCN	No	No
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-001	Oct 27, 1986		DISCN	Yes	No
Watson Labs	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	074145-001	Oct 17, 1995	AB	RX	No	No
Xiromed	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET;ORAL	218326-001	Feb 23, 2024	AB	RX	No	No

Expired US Patents for GUANFACINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	5,854,290*PED
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-002	Nov 7, 1988	3,632,645
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	6,287,599*PED
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	6,811,794*PED

GUANFACINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Guanfacine Hydrochloride Tablets: Market Dynamics and Financial Trajectory

Introduction

Guanfacine hydrochloride tablets, known by the brand name Intuniv among others, are a non-stimulant medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Here, we delve into the market dynamics and financial trajectory of this medication, exploring its growth drivers, market segments, regional analysis, and competitive landscape.

Market Drivers

The guanfacine hydrochloride tablets market is driven by several key factors:

Increasing Prevalence of ADHD

The rising prevalence of ADHD globally is a significant driver for the market. As awareness about the disorder increases, more patients are seeking effective treatment options, leading to higher demand for guanfacine hydrochloride tablets[1].

Development of Novel Formulations

The introduction of extended-release tablets and orally disintegrating tablets has enhanced patient convenience and adherence. These formulations minimize the fluctuation of guanfacine plasma concentrations, making them more appealing to both patients and healthcare providers[1][3].

Expanding Indications

Guanfacine hydrochloride tablets are being explored for additional indications, such as the treatment of oppositional defiant disorder (ODD), conduct disorder (CD), anxiety disorders, tic disorders, and sleep disturbances associated with ADHD. This expansion is expected to further drive market growth[1].

Adjunctive Therapy

The use of guanfacine hydrochloride tablets as an adjunctive therapy to stimulant medications is gaining traction. This is particularly beneficial for patients who have a suboptimal response or intolerance to stimulants, creating new growth avenues for the market[1][3].

Market Segment Analysis

By Distribution Channel

The retail pharmacy segment dominates the market due to the wide availability of the drug and the convenience of obtaining prescriptions and refills. Online pharmacies are also growing rapidly, driven by the increasing adoption of e-prescribing and the preference for online purchasing. Hospital pharmacies, though smaller, are expected to grow steadily as ADHD diagnosis and treatment increase in hospital settings[1].

By Region

• North America: This region is the largest market for guanfacine hydrochloride tablets, driven by the high prevalence of ADHD, well-established healthcare infrastructure, and favorable reimbursement scenarios. The United States is a major contributor to this market[1].
• Europe: Europe is the second-largest market, supported by the rising prevalence of ADHD and increasing focus on mental health. The region has seen approvals for guanfacine hydrochloride tablets with specific restrictions[1][2].
• Asia-Pacific: This region is projected to witness the highest growth rate, fueled by a large patient population, improving healthcare infrastructure, and increasing awareness about ADHD in countries like China, India, and Japan[1].

Competitive Landscape

The market is characterized by a competitive landscape with several key players. The development of novel formulations and the expanding indications for guanfacine hydrochloride tablets are driving innovation and competition. However, challenges such as the availability of generic versions and potential side effects may impact market growth to some extent[1].

Side Effects and Safety Concerns

Common adverse events associated with guanfacine include somnolence, headache, fatigue, hypotension, bradycardia, and syncope. These side effects necessitate careful monitoring of heart rate and blood pressure before and during treatment[2].

Generic Versions

The availability of generic versions of guanfacine hydrochloride tablets can restrain market growth, as generics often offer a more affordable alternative to branded medications[1].

Financial Trajectory

Market Size and Growth

The global guanfacine hydrochloride tablets market is expected to witness significant growth from 2024 to 2033, driven by the increasing prevalence of ADHD and the development of novel formulations. The market size is projected to expand substantially, with North America and Europe leading the way[1].

Revenue Streams

Revenue is primarily generated through retail pharmacies, followed by online pharmacies and hospital pharmacies. The increasing adoption of e-prescribing and online purchasing is expected to boost revenue from online channels[1].

Investment and Collaborations

Pharmaceutical companies are investing in research and development to enhance the efficacy and safety of guanfacine hydrochloride tablets. Collaborations between pharmaceutical companies and healthcare providers to increase awareness and improve patient access are also driving market growth[1].

Regional Utilization Patterns

European Utilization

A multi-country retrospective drug utilization study in Europe revealed that guanfacine hydrochloride is mainly prescribed within the label for ADHD patients who had previously been treated with stimulant medications. However, there is variability in prescriber compliance, particularly in the use of guanfacine in adult patients across different countries[5].

Key Takeaways

• The guanfacine hydrochloride tablets market is driven by the increasing prevalence of ADHD, novel formulations, and expanding indications.
• North America and Europe are the largest markets, with the Asia-Pacific region expected to show the highest growth rate.
• Retail pharmacies dominate the distribution channel, but online pharmacies are growing rapidly.
• The market faces challenges from generic versions and potential side effects.
• Collaborations and investments in research and development are crucial for market growth.

FAQs

What is guanfacine hydrochloride used for?

Guanfacine hydrochloride is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. It is also explored for other indications such as ODD, CD, anxiety disorders, and sleep disturbances associated with ADHD[1][2].

What are the common side effects of guanfacine hydrochloride?

Common side effects include somnolence, headache, fatigue, hypotension, bradycardia, and syncope. Heart rate and blood pressure should be monitored before and during treatment[2].

How does guanfacine hydrochloride compare to stimulant medications?

Guanfacine hydrochloride monotherapy is less effective than stimulant medications but more effective than placebo. As an adjunctive treatment to stimulants, it significantly improves response and remission rates[2].

What are the novel formulations of guanfacine hydrochloride?

Novel formulations include extended-release tablets and orally disintegrating tablets, which enhance patient convenience and adherence by minimizing the fluctuation of guanfacine plasma concentrations[1][3].

Which regions are expected to drive the growth of the guanfacine hydrochloride tablets market?

North America and Europe are currently the largest markets, while the Asia-Pacific region is expected to witness the highest growth rate due to a large patient population and improving healthcare infrastructure[1].

Sources

1. DataHorizon Research: Guanfacine Hydrochloride Tablets Market Size, Share, Growth, Trends, Statistics Analysis Report and By Segment Forecasts 2024 to 2033.
2. NPS MedicineWise: Guanfacine (Intuniv) for attention deficit hyperactivity disorder.
3. FDA: 22037 Guanfacine Clinpharm PREA.
4. Market Research Intellect: Guanfacine Hydrochloride Tablets Market Size, Scope And Forecast.
5. ISPOR: Drug utilization patterns of guanfacine hydrochloride in European countries.