ACTOS Drug Patent Profile

When do Actos patents expire, and when can generic versions of Actos launch?

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

The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Actos

A generic version of ACTOS was approved as pioglitazone hydrochloride by CHARTWELL RX on October 26^th, 2012.

Summary for ACTOS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	145
Patent Applications:	3,978
Drug Prices:	Drug price information for ACTOS
Drug Sales Revenues:	Drug sales revenues for ACTOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOS
What excipients (inactive ingredients) are in ACTOS?	ACTOS excipients list
DailyMed Link:	ACTOS at DailyMed

See drug prices for ACTOS

See drug sales revenues for ACTOS

Pharmacology for ACTOS

Drug Class	Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity

US Patents and Regulatory Information for ACTOS

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	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	AB	RX	Yes	No
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	AB	RX	Yes	No
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	AB	RX	Yes	Yes

Expired US Patents for ACTOS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	5,965,584
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	6,211,205
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	4,687,777
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	6,303,640
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	4,444,779

International Patents for ACTOS

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

Country	Patent Number	Title	Estimated Expiration
Australia	5246786
Cyprus	2424	Pharmaceutical composition for use in treatment ofdiabetes.
Denmark	1174135
European Patent Office	1764110
Japan	3148973

Supplementary Protection Certificates for ACTOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135	CA 2009 00045	Denmark
0193256	SPC/GB01/016	United Kingdom		PRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126
1174135	SPC/GB10/011	United Kingdom		PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
1174135	SPC026/2009	Ireland		SPC026/2009: 20101001, EXPIRES: 20210619

Market Dynamics and Financial Trajectory of Actos (Pioglitazone HCl)

Introduction

Actos, also known as pioglitazone HCl, is a widely used oral antidiabetic medication developed by Takeda Pharmaceutical Company Limited. It is primarily used to manage Type 2 Diabetes Mellitus by enhancing peripheral sensitivity to insulin. Here, we delve into the market dynamics and financial trajectory of Actos, highlighting its growth, challenges, and strategic partnerships.

Market Growth and Sales Performance

Global Sales and Market Share

Actos has been a significant contributor to Takeda's revenue. In 2006, Actos saw remarkable growth, with sales increasing by 45% year-on-year to ¥161.4 billion (approximately $1.4 billion), driven by strong performance in Japan, the Americas, Europe, and Asia[2].

Impact of Competitive Landscape

The market share of Actos was significantly boosted following a report by the Cleveland Clinic suggesting that Avandia, a competitor drug by GlaxoSmithKline, increased the risk of heart attacks by 43%. This led to a 13% rise in Actos sales within two weeks, while Avandia prescriptions declined substantially[1].

Financial Trajectory

Revenue Contribution

Actos was Takeda's best-selling drug, accounting for a quarter of the company's revenue in 2006. With global sales of $2.8 billion, it played a crucial role in Takeda's financial performance[1].

Profit Forecasts and Performance

Takeda raised its recurring profit forecasts by 11% to ¥540 billion (approximately $4.6 billion) in 2006, largely due to the strong sales performance of Actos. This boost helped Takeda's overall sales rise by 7.1% to ¥642.4 billion (approximately $5.4 billion) during the first half of the fiscal year 2006/07[2].

Strategic Partnerships and Distribution

Co-Promotion Agreement with Pfizer

In 2009, Takeda and Pfizer entered into an exclusive co-promotion agreement to enhance the sales and marketing of Actos in China. This partnership leveraged Pfizer's extensive network in China, increasing the reach and availability of Actos to patients and healthcare providers[5].

Expansion in Emerging Markets

The partnership with Pfizer in China was part of Takeda's broader strategy to expand its presence in emerging markets. Given China's rapid urbanization and economic expansion, the market presented significant growth opportunities for Actos[5].

Market Drivers and Opportunities

Increasing Diabetes Prevalence

The global rise in Type 2 diabetes cases has been a key driver for the demand of pioglitazone hydrochloride tablets. The increasing incidence of diabetes, particularly in aging populations and emerging economies, has provided substantial market opportunities for Actos[3].

Clinical Competitiveness

The release of studies such as CHICAGO and PERISCOPE further enhanced the clinical competitiveness of Actos, supporting its market position and growth prospects[2].

Market Restraints and Challenges

Adverse Side Effects and Safety Concerns

Actos has faced challenges due to adverse side effects such as weight gain, fluid retention, and increased risk of heart failure. These safety concerns have led to regulatory warnings and impacted consumer confidence[1][3].

Regulatory Frameworks and Patent Expirations

Takeda faced the impending patent expiration of Actos in 2011, which posed a significant challenge. Additionally, stringent regulatory frameworks and the need for continuous innovation to stay competitive have been ongoing challenges[2][3].

Innovation and R&D

Product Development and Combination Therapies

To address side effects and stay competitive, Takeda has focused on developing combination therapies and improving drug formulations. For example, the introduction of Competact (pioglitazone/metformin) and Duetact (pioglitazone/sulfonylurea) has been part of this strategy[2].

Research and Development Expenditure

Takeda has invested significantly in R&D, with expenditure rising by 17% to equate to 15% of sales in the first half of FY2006/07. This includes research into new candidates such as TAK-491 for hypertension and Hematide for anaemia[2].

Market Penetration and Diversification

Geographic Expansion

Actos has seen significant growth across various geographic regions, including Japan, the Americas, Europe, and Asia. North American sales, in particular, were strong, rising by 28% to ¥206 billion in the first half of FY2006/07[2].

Product Diversification

Takeda's portfolio expansion, including the introduction of new drugs like Rozerem and Amitizia, has helped diversify its revenue streams and mitigate risks associated with single-product dependence[2].

Competitive Assessment

Market Share and Competitive Landscape

Actos has maintained a strong market share in the diabetes treatment segment. However, the competitive landscape is dynamic, with other diabetes treatments and emerging therapies posing continuous competition[1][3].

Strategic Approaches and Certifications

Takeda's strategic approaches, including co-promotion agreements and direct-to-consumer advertising, have been crucial in maintaining market share. Regulatory approvals and certifications have also played a significant role in ensuring the drug's credibility and market presence[5].

Key Takeaways

• Actos has been a key revenue driver for Takeda, with significant sales growth driven by its effectiveness in managing Type 2 diabetes.
• Strategic partnerships, such as the co-promotion agreement with Pfizer in China, have enhanced its market reach.
• Despite challenges from adverse side effects and regulatory pressures, Actos has maintained a strong market position through continuous innovation and R&D.
• The drug's success is closely tied to the increasing global prevalence of diabetes and the aging population.

FAQs

1. What is Actos used for?

Actos, or pioglitazone HCl, is used to manage Type 2 Diabetes Mellitus by enhancing peripheral sensitivity to insulin.

2. How did the Cleveland Clinic report impact Actos sales?

The report suggesting Avandia increased the risk of heart attacks led to a 13% rise in Actos sales within two weeks, as prescriptions for Avandia declined.

3. What was the impact of the co-promotion agreement with Pfizer on Actos sales in China?

The agreement increased the number of medical representatives supporting Actos sales and expanded the product's reach utilizing Pfizer's extensive network in China.

4. What are the main challenges faced by Actos in the market?

Actos faces challenges from adverse side effects, regulatory pressures, and the impending patent expiration, which necessitate continuous innovation and strategic partnerships.

5. How has Takeda addressed the issue of side effects associated with Actos?

Takeda has focused on developing combination therapies and improving drug formulations to reduce side effects, such as the introduction of Competact and Duetact.

Cited Sources:

1. Actos gains market share at Avandia's expense - MM+M
2. Actos Drives H1 Sales, as Takeda Raises Forecast - S&P Global
3. Pioglitazone Hydrochloride Tablets Market Size 2025-2030 - 360iResearch
4. Pharmaceutical spending trends and future challenges - OECD
5. Takeda and Pfizer to Co-Promote Takeda's Actos® (Pioglitazone HCl) for the Treatment of Type 2 Diabetes in China - Pfizer