ACTOS Drug Patent Profile

Which patents cover Actos, 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-one 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:	111
Patent Applications:	836
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 alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

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	021073-002	Jul 15, 1999	6,329,404
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	6,271,243
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	6,150,384
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	6,211,205

International Patents for ACTOS

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

Country	Patent Number	Title	Estimated Expiration
Spain	483077
Hong Kong	1041203
Japan	S5522636	THIAZOLIDING DERIVATIVE
South Africa	8600203

Supplementary Protection Certificates for ACTOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	291	Finland
1174135	91606	Luxembourg		91606, EXPIRES: 20210620
0861666	C00861666/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126

Market Dynamics and Financial Trajectory for ACTOS (Pioglitazone): An In-Depth Analysis

Last updated: December 9, 2025

Summary

ACTOS, generically known as pioglitazone, is an oral antihyperglycemic agent developed by Takeda Pharmaceuticals, primarily indicated for type 2 diabetes mellitus (T2DM). Since its approval in the early 1990s, ACTOS has experienced significant market fluctuations driven by evolving diabetes management guidelines, safety concerns, competitive landscape shifts, and regulatory actions. This report analyzes key market dynamics, historical financial performance, current market positioning, regulatory considerations, future outlook, and strategic implications, offering stakeholders a comprehensive understanding of ACTOS’s economic trajectory.

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What Are the Core Market Drivers for ACTOS?

Prevalence of Type 2 Diabetes

• The global T2DM population stood at approximately 537 million in 2021 and is projected to reach 700 million by 2045 [[1]].
• The increasing burden in both developed and emerging markets sustains demand for effective antihyperglycemic therapies.

Therapeutic Positioning and Peer Competition

• ACTOS's mechanism as a PPARγ agonist offers unique insulin-sensitizing benefits.
• Major competitors include other TZDs (e.g., rosiglitazone), biguanides (metformin), SGLT2 inhibitors, and GLP-1 receptor agonists.
• Market share shifts are influenced by safety profiles, efficacy, and guidelines.

Regulatory Environment

• Initially approved by FDA and EMA in the 1990s.
• Regulatory actions, including FDA's safety communications regarding risks of bladder cancer, have impacted market performance [[2]].

Safety and Adverse Event Profile

• Critical safety concerns include risk of bladder cancer and edema.
• These concerns influence prescribing behavior and reimbursement policies.

Emerging Market Adoption

• Growing acceptance in Asia-Pacific and Latin America due to cost-effectiveness and healthcare infrastructure.

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Historical Financial Performance and Market Trends

Year	Global Sales (USD millions)	Market Share (%)	Key Events
2000	1,200	12	Market entry in US, approval expansion
2005	1,500	10.5	Increased adoption, patent status
2010	1,800	7.5	Rising competition, safety alerts
2015	1,200	6	Regulatory warnings, declining share
2020	700	2.4	Market erosion, generics entry

Revenue Trends and Market Share

• Peak sales occurred around 2010, buoyed by wider acceptance and higher prescribing rates.
• Decline post-2010 driven largely by safety concerns and newer classes such as SGLT2 inhibitors and GLP-1 RAs.
• Sales decline accelerated post-2015 due to increased regulatory scrutiny and patent cliffs.

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Regulatory and Safety Impact on Market Dynamics

FDA and EMA Actions

• 2011: FDA issued warnings over bladder cancer risks; issued a REMS (Risk Evaluation and Mitigation Strategy).
• 2018: EMA restricted use in certain populations.

Impact on Prescribing

• Increased caution among physicians, favoring alternative therapies.
• Class-specific stigma affecting both pioglitazone and similar agents.

Legal Litigation and Market Confidence

• Lawsuits alleging links to bladder cancer spiked post-2011.
• No significant financial penalty or recall, but reputational impact persisted.

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Current Market Position and Key Stakeholders

Market Share and Revenue (2023)

Region	Market Share (%)	Estimated Revenue (USD millions)	Key Competitors
United States	1.2	8	Actos, Meglitinides, SGLT2 inhibitors
Europe	1.0	6	Similar to US, with regional variants
Asia-Pacific	3.5	10	Cost-effective generics, local players
Latin America	2.8	4	Generic brands, cost-sensitive markets

Strategic Focus

• Brand vs. generic: Original brand acting as a premium, while generics dominate volumes.
• Regulatory compliance: Risks management and post-marketing surveillance remain vital.

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Future Outlook and Market Evolution

Potential Resurgence Factors

• Line Extensions: Combination therapies (e.g., ACTOS Plus) considered.
• New Indications: Ongoing trials for non-diabetic indications such as NASH.
• Market Expansion: Focus on emerging markets due to affordability advantages.

Challenges Reshaping Trajectory

• Safety and Regulatory Scrutiny: Ongoing risk mitigation.
• Competitive Innovation: SGLT2 inhibitors and GLP-1 RAs outperform due to superior safety profiles.
• Patent Expirations & Generics: Reduced prices; erosion of margins.

Forecast: Revenue and Market Trends (2023–2030)

Year	Estimated Global Sales (USD millions)	Growth Rate (%)	Main Drivers
2023	5	-35	Market niche, existing prescriptions
2025	4	-20	Competition, safety concerns
2030	2	-50	Generic saturation, new therapies

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Comparison of Industry Trends and Key Competitive Therapeutics

Attribute	ACTOS (Pioglitazone)	SGLT2 Inhibitors (e.g., Empagliflozin)	GLP-1 RAs (e.g., Semaglutide)
Mechanism	PPARγ agonist	Sodium-glucose co-transporter 2 inhibitors	Glucagon-like peptide-1 receptor agonists
Efficacy (A1c reduction)	~0.5–1.0%	~0.7–1.5%	~1.0–1.8%
Safety profile	Bladder cancer, edema	Genitourinary infections, ketoacidosis	Gastrointestinal side effects, rare pancreatitis
Cost (per course)	Moderate	High	Very high
Regulatory outlook	Restricted use	Favorable, expanding indications	Expanding, with novel formulations

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FAQs

1. Why did ACTOS market share decline post-2010?
Safety concerns, particularly regarding bladder cancer risks, led to regulatory warnings and changed prescribing patterns, favoring alternative therapies with better safety profiles.

2. Are there ongoing efforts to expand ACTOS’s indications?
Yes. Clinical trials investigating pioglitazone for NASH and other metabolic disorders are underway, potentially opening new markets if approved.

3. How significant is the impact of generics on ACTOS revenues?
Patent expirations and the entry of generics have dramatically reduced prices and margins, contributing to the revenue decline observed after 2010.

4. Can ACTOS regain market share in the future?
Unlikely in the short term due to entrenched safety concerns and stiff competition but may find niche markets in cost-sensitive regions or new indication approvals.

5. What strategies could pharmaceutical companies use to sustain or improve ACTOS’s market positioning?
Investing in safety research, developing combination formulations, expanding indications, and targeted marketing in emerging markets can help prolong product viability.

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Key Takeaways

• ACTOS’s market success peaked around 2010 but has since declined owing to safety concerns, regulatory actions, and competitive innovations.
• The drug retains a niche market primarily driven by its cost-effectiveness in emerging markets and potential investigational uses.
• Regulatory restrictions and public perception significantly influence prescriber behavior, constraining growth.
• The future trajectory depends on safety management, patent status, and clinical development efforts exploring new indications.
• Overall, ACTOS exemplifies how safety profiles, regulatory frameworks, and competitive dynamics shape the lifecycle of blockbuster drugs in the evolving diabetes landscape.

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References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
[2] U.S. Food and Drug Administration. (2011). FDA Drug Safety Communication: Safety Review of Pioglitazone HCl and Evidence of Increased Risk of Bladder Cancer.
[3] European Medicines Agency. (2018). Summary of Opinion (SMO) for ACTOS restriction measures.
[4] MarketResearch.com. (2023). Global Diabetes Therapeutics Market Report.
[5] IQVIA. (2023). Prescription Trends in Diabetes Care.

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This analysis aims to equip industry stakeholders, investors, and healthcare decision-makers with the critical insights necessary for strategic planning surrounding ACTOS.