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, Fosun Wanbang, Impax Labs Inc, Pharmobedient, Rubicon Research, Sandoz, Sun Pharm, Teva Pharms Usa, Twi Pharms, Unichem, Yichang Humanwell, Takeda Pharms Usa, Aiping Pharm Inc, Ajanta Pharma Ltd, Amneal Pharm, Aurobindo Pharma Usa, Epic Pharma Llc, I 3 Pharms, Watson Labs, Xiromed, and Promius Pharma, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for GUANFACINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	26
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	76
Patent Applications:	1,996
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
Stanford University	PHASE2
Indiana University	PHASE2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2

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
Yichang Humanwell	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213428-003	Nov 25, 2020	AB	RX	No	No
Alembic	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	217269-002	Aug 7, 2023	AB	RX	No	No
Pharmobedient	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202578-003	Jun 2, 2015		DISCN	No	No
Unichem	GUANFACINE HYDROCHLORIDE	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	219033-002	Nov 19, 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	022037-003	Sep 2, 2009
Promius Pharma	TENEX	guanfacine hydrochloride	TABLET;ORAL	019032-003	Nov 7, 1988
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009

Market Dynamics and Financial Trajectory for Guanfacine Hydrochloride

Last updated: July 27, 2025

Introduction

Guanfacine hydrochloride, a selective alpha-2 adrenergic receptor agonist, has established its role primarily in the treatment of attention deficit hyperactivity disorder (ADHD) and hypertension. Over recent years, the landscape of its market dynamics and financial trajectory has evolved due to shifting regulatory standards, emerging therapeutic applications, and competitive market pressures. This report explores these factors, offering an analytical perspective on the current and future positioning of guanfacine hydrochloride within global pharmaceutical markets.

Market Overview and Therapeutic Applications

Guanfacine hydrochloride’s primary indications—ADHD and hypertension—dictate market patterns rooted in prevalence, diagnostic rates, and treatment guidelines. ADHD remains one of the most common neurodevelopmental disorders, affecting approximately 5-10% of children worldwide. The rising diagnosis rates and growing acceptance of pharmacological management boost demand for guanfacine formulations, both immediate and extended-release variants.

In hypertension management, guanfacine occupies a niche position, often reserved for cases refractory to first-line agents or when co-existing psychiatric conditions necessitate its use. Its dual utility enhances market opportunities but also exposes the drug to competition from a broader class of antihypertensives.

Recent innovation includes extended-release formulations, such as Intuniv (marketed by Shire/Takeda), which have enhanced adherence profiles. The launch of novel formulations tailored for pediatrics and adults extends the drug’s reach, influencing revenue streams positively.

Market Dynamics

Regulatory Landscape

Regulatory pathways significantly influence guanfacine hydrochloride’s market trajectory. Its approval status varies across regions:

• United States: Approved by the FDA for ADHD (both immediate and extended-release formulations). The recent endorsement of generic versions has intensified market competition, driving down prices and eroding profit margins for branded products.
• European Union: Limited approval, with some markets prescribing off-label for ADHD. Regulatory restrictions impact sales volume and reimbursement.

Furthermore, ongoing patent expirations affect the exclusivity period. While primary patents expired around 2017, secondary patents on formulations or delivery systems could prolong market protection temporarily, though patent cliffs generally encourage generic entry.

Competitive Landscape

The pharmaceutical market for ADHD encompasses several high-profile drugs, including methylphenidate, amphetamines, and non-stimulant options like atomoxetine. Guanfacine’s distinctive mechanism—non-stimulant, with a favorable side effect profile—positions it as a preferred alternative for specific patient groups.

The entrance of generics has precipitated price reductions, intensifying competition. Additionally, newer non-stimulant drugs with improved efficacy or safety profiles threaten guanfacine’s market share.

Market Drivers

• Growing ADHD Diagnosis and Treatment Adoption: Increasing awareness, destigmatization, and evolving treatment guidelines favor drugs like guanfacine.
• Extended-Release Formulations: Improved compliance and perceived safety contribute to sustained demand.
• Expansion into Adult Psychiatry: Clinical evidence supporting guanfacine’s use in adult ADHD broadens the market.

Market Challenges

• Generic Competition and Price Erosion: The proliferation of generics lowers revenues.
• Side Effect Profile and Tolerability Issues: Side effects such as hypotension, sedation, and fatigue may limit broader adoption.
• Limited Indications: A narrow therapeutic scope constrains revenue growth potential.
• Regulatory Hurdles and Off-Label Uses: Off-label prescribing can lead to regulatory scrutiny, affecting commercialization strategies.

Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Data from pharmaceutical sales databases indicate that guanfacine revenue peaked circa 2015-2016, driven by robust demand for branded formulations like Intuniv. After patent expiry and the influx of generics, revenues declined notably. For instance, the global ADHD drug market, estimated at USD 20 billion in 2021, has seen stimulants dominate with over 70% market share, but non-stimulants like guanfacine contribute a stable niche segment (~10-15%).

Projected Growth

Market analysts project a compound annual growth rate (CAGR) of approximately 4-6% for non-stimulant ADHD medications over the next five years, attributable to increased diagnosis rates and new formulation launches. Specifically, guanfacine’s market share is expected to stabilize or slightly decline due to generic penetration but could benefit from:

• Product Line Extensions: Development of combo therapies and alternative formulations.
• Expanding Indications: Clinical trials exploring guanfacine’s efficacy in conditions like opioid dependence or tic disorders.
• Regional Market Expansion: Growing markets in Asia-Pacific and Latin America present emerging revenue avenues.

Revenue Impact Factors

• Pricing Strategies: Shift toward generic substitution pressures branded drug prices downward.
• Reimbursement Policies: Reimbursement limits and formulary placements influence sales volumes.
• Market Penetration: Territory-specific adoption rates result from local medical guidelines and clinical practices.
• Patent Litigation and Exclusivity Periods: These legal factors inherently dictate revenue sustainability.

Financial Outlook Summary

Considering current market trends, the revenue trajectory for guanfacine hydrochloride is modest, with an expected decline in branded product sales due to generic competition. However, strategic diversification—such as entering new indications and markets—could stabilize or enhance profitability in niche segments.

Investment and Industry Implications

For pharmaceutical companies, the key lies in balancing innovation with cost competitiveness. The expiration of primary patents necessitates strategic shifts toward biosimilars, new formulations, or combination therapies to preserve market share. Additionally, research into expanding therapeutic indications offers meaningful growth opportunities.

Investors should monitor regulatory developments and clinical trial outcomes, especially those that could bolster guanfacine’s efficacy profile or broaden its use cases.

Conclusion

Guanfacine hydrochloride's future within the pharmaceutical landscape hinges on navigating patent expirations, competitive pressures from generics, and evolving clinical needs. While revenues have plateaued or declined in mature markets, growth prospects persist within emerging markets, new formulations, and expanded indications. Stakeholders must adopt dynamic strategies encompassing innovation, regulatory engagement, and market access to optimize financial returns.

---

Key Takeaways

• Guanfacine hydrochloride's primary markets are ADHD and hypertension, with recent growth driven by extended-release formulations.
• Patent expiration and the entry of generics have significantly impacted profitability, intensifying price competition.
• Market growth momentum hinges on expanding indications and regional market penetration, especially in Asia-Pacific.
• Industry players should focus on formulation innovation and clinical research to differentiate and sustain revenue streams.
• Investment risks include regulatory hurdles, side effect profiles, and market saturation, emphasizing the need for strategic planning.

---

FAQs

1. How does patent expiration affect guanfacine hydrochloride’s market potential?
Patent expiry leads to the entry of generics, significantly reducing prices and profit margins for branded formulations. It encourages competition, often resulting in revenue decline unless offset by new formulations or indications.

2. What are the main competitive risks facing guanfacine in the ADHD market?
Competition from stimulants and other non-stimulant drugs, such as atomoxetine, coupled with generic price erosion and emerging therapies, pose significant risks to market share.

3. Can guanfacine hydrochloride expand into new therapeutic areas?
Yes. Evidence suggests potential in treating tic disorders, opioid dependence, and possibly in managing certain psychiatric conditions, contingent upon successful clinical trials and regulatory approval.

4. What regional factors influence guanfacine’s financial trajectory?
Regulatory approval status, healthcare infrastructure, diagnostic prevalence, and reimbursement policies vary across regions, impacting sales volume and growth potential.

5. How should pharmaceutical companies position themselves to maximize guanfacine’s value?
Integrating formulation innovation, advocating for expanded indications, securing strategic partnerships, and optimizing pricing and access strategies are essential for maximizing market value.

---

Sources:

[1] IQVIA, Global ADHD Market Analysis, 2022.
[2] FDA Official Drug Approvals Database, 2023.
[3] Market Research Future, Non-Stimulant ADHD Drugs Market Forecast, 2022-2027.
[4] Pharma Intelligence, Patent Expiry Reports, 2022.
[5] GlobalData, Regional Market Penetration Studies, 2022.