INTUNIV Drug Patent Profile

Which patents cover Intuniv, and when can generic versions of Intuniv launch?

Intuniv is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in INTUNIV is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intuniv

A generic version of INTUNIV was approved as guanfacine hydrochloride by WATSON LABS on October 17^th, 1995.

Summary for INTUNIV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	29
Patent Applications:	823
Drug Prices:	Drug price information for INTUNIV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INTUNIV
What excipients (inactive ingredients) are in INTUNIV?	INTUNIV excipients list
DailyMed Link:	INTUNIV at DailyMed

See drug prices for INTUNIV

See drug sales revenues for INTUNIV

Recent Clinical Trials for INTUNIV

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

Sponsor	Phase
Maimonides Medical Center	Phase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2
Takeda Development Center Americas, Inc.	Phase 4

See all INTUNIV clinical trials

Pharmacology for INTUNIV

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

Paragraph IV (Patent) Challenges for INTUNIV

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 INTUNIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	AB	RX	Yes	No
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	AB	RX	Yes	Yes
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-002	Sep 2, 2009	AB	RX	Yes	No
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	AB	RX	Yes	No

Expired US Patents for INTUNIV

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
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
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	5,854,290*PED

International Patents for INTUNIV

See the table below for patents covering INTUNIV around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4340840
Japan	2004518676
World Intellectual Property Organization (WIPO)	9816226
Spain	2527854

INTUNIV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INTUNIV

Introduction

INTUNIV, a nonstimulant medication containing guanfacine, is a significant player in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This article delves into the market dynamics and financial trajectory of INTUNIV, highlighting its impact, market performance, and future outlook.

Market Overview of ADHD Treatments

The ADHD treatment market is robust and growing, driven by increasing diagnosis rates and advancements in treatment options. The global ADHD market is projected to reach USD 13.6 billion by 2034, growing at a CAGR of 3.23% from 2024 to 2034[4].

INTUNIV: A Nonstimulant Option

INTUNIV (guanfacine extended-release tablets) is indicated for the treatment of ADHD as monotherapy or as an adjunct to stimulant medications. It is particularly notable for being a nonstimulant option, which appeals to patients and healthcare providers seeking alternatives to traditional stimulant therapies[1].

Market Performance of INTUNIV

In 2015, Teva Pharmaceutical Industries launched the generic equivalent of INTUNIV in the United States, marking a significant milestone. The branded version of INTUNIV had total market sales of approximately $804 million in the United States as of March 2015[1].

Sales and Revenue

The introduction of the generic version by Teva expanded the availability and affordability of guanfacine extended-release tablets. This move was part of Teva's strategy to enhance its ADHD product line, which already included seven other ADHD products[1].

Impact on Shire's Financials

Before the generic launch, INTUNIV was a key product for Shire Pharmaceuticals. In 2015, Shire reported strong revenue growth, but the sales of INTUNIV were excluded from some of these figures to highlight the performance of other products. For instance, Shire's product sales excluding INTUNIV grew by 10% (14% on a Non-GAAP CER basis) in 2015, driven by other successful products like VYVANSE[2].

Competitive Landscape

The ADHD treatment market is highly competitive, with several key players including Shire (now part of Takeda), Teva, and others. The market is driven by the performance of both stimulant and nonstimulant medications.

Role of Nonstimulant Treatments

Nonstimulant treatments like INTUNIV are gaining traction due to their unique benefits and the need for diverse treatment options. Research into genetic and neurobiological aspects of ADHD is further fueling the development of targeted therapies, including nonstimulant medications[4].

Financial Trajectory

Revenue and Sales

The financial performance of INTUNIV has been significant, although it has faced challenges with the introduction of generic versions. The branded version's sales were substantial, but the generic launch by Teva and other competitors has impacted the revenue trajectory.

Generic Competition

The launch of generic guanfacine extended-release tablets by Teva and potentially other manufacturers has reduced the market share and revenue of the branded INTUNIV. This is a common trend in the pharmaceutical industry where generic versions erode the market share of branded drugs once their patents expire[1].

Impact on Parent Companies

For companies like Shire, the introduction of generic versions of INTUNIV has necessitated a focus on other products and pipeline developments to maintain revenue growth. Shire's financial reports reflect this strategy, with growth driven by other products like VYVANSE[2].

Regional Analysis

The United States is the largest market for ADHD treatments, including INTUNIV. The robust demand for both pharmaceutical and non-pharmaceutical treatments in the U.S. drives the market dynamics for ADHD medications[4].

Future Outlook

The future outlook for INTUNIV and similar nonstimulant ADHD treatments is promising. As the ADHD market continues to grow, there will be an increasing demand for diverse treatment options, including nonstimulant medications.

Market Growth Projections

The global nonstimulant ADHD treatment market is expected to grow, driven by increasing diagnosis rates and advancements in treatment services. The U.S. market, in particular, is projected to see significant growth in the nonstimulant ADHD treatment segment[3][4].

Research and Development

Ongoing research into the genetic and neurobiological aspects of ADHD is expected to drive the development of more targeted and effective treatments, including nonstimulant options like INTUNIV[4].

Key Takeaways

• Market Growth: The ADHD treatment market, including nonstimulant options like INTUNIV, is expected to grow significantly.
• Generic Competition: The introduction of generic versions has impacted the revenue trajectory of branded INTUNIV.
• Diverse Treatment Options: The demand for nonstimulant treatments is increasing, driven by the need for diverse treatment options.
• Regional Dominance: The United States is the largest market for ADHD treatments.
• Future Outlook: The future looks promising for nonstimulant ADHD treatments, driven by growing demand and ongoing research.

FAQs

Q: What is INTUNIV used for?

A: INTUNIV (guanfacine extended-release tablets) is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as an adjunct to stimulant medications.

Q: Who launched the generic version of INTUNIV in the United States?

A: Teva Pharmaceutical Industries launched the generic equivalent of INTUNIV in the United States in 2015.

Q: How much did the branded version of INTUNIV generate in sales in 2015?

A: The branded version of INTUNIV had total market sales of approximately $804 million in the United States as of March 2015.

Q: What is driving the growth of the ADHD treatment market?

A: The growth is driven by increasing diagnosis rates, advancements in treatment services, and research into the genetic and neurobiological aspects of ADHD.

Q: Which region is the largest market for ADHD treatments?

A: The United States is the largest market for ADHD treatments, including nonstimulant options like INTUNIV.

Sources

1. Teva Pharmaceutical Industries Ltd. - Teva Enhances ADHD Product Line with Generic INTUNIV® in the United States.
2. Shire - Shire Delivers Record Full-year Revenue and Strong Double Digit Growth in Non GAAP Diluted Earnings Per ADS.
3. Market Research Reports - Global Nonstimulant ADHD Treatment Drugs Market Growth (Status and Outlook) 2024-2030.
4. BioSpace - Attention Deficit Hyperactivity Disorder Market Size to Reach USD 13.6 Billion by 2034.