ACTOPLUS MET XR Drug Patent Profile

Which patents cover Actoplus Met Xr, and when can generic versions of Actoplus Met Xr launch?

Actoplus Met Xr is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in twenty-five countries.

The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Actoplus Met Xr

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ACTOPLUS MET XR

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	87
Drug Prices:	Drug price information for ACTOPLUS MET XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOPLUS MET XR
DailyMed Link:	ACTOPLUS MET XR at DailyMed

See drug prices for ACTOPLUS MET XR

Recent Clinical Trials for ACTOPLUS MET XR

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Torrent Pharmaceuticals Limited	Phase 1

See all ACTOPLUS MET XR clinical trials

Paragraph IV (Patent) Challenges for ACTOPLUS MET XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACTOPLUS MET XR	Extended-release Tablets	metformin hydrochloride; pioglitazone hydrochloride	15 mg/1000 mg and 30 mg/1000 mg	022024	1	2011-09-23

US Patents and Regulatory Information for ACTOPLUS MET XR

ACTOPLUS MET XR is protected by two US patents.

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	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		DISCN	Yes	No	7,959,946		Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No	7,785,627		Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		DISCN	Yes	No	7,785,627		Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No	7,959,946		Y

Expired US Patents for ACTOPLUS MET XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	6,495,162
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,495,162
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,790,459
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,172,090
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	9,060,941
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,166,043
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	8,475,841

International Patents for ACTOPLUS MET XR

When does loss-of-exclusivity occur for ACTOPLUS MET XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ACTOPLUS MET XR around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004026241
South Africa	9605190
South Korea	20050053677	MULTISTAGE FORMULATION CONTAINING A BIGUANIDE AND THIAZOLIDINDIONE DERIVATIVES
Singapore	160415	NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE
Australia	723097
Japan	2007191494	MEDICINE
South Korea	101249171

Supplementary Protection Certificates for ACTOPLUS MET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1532149	132013902118390	Italy		PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
0861666	300258	Netherlands		300258, 20160620, EXPIRES: 20210619

Market Dynamics and Financial Trajectory for ACTOPLUS MET XR

Last updated: July 27, 2025

Introduction

ACTOPLUS MET XR is a combination pharmaceutical product approved for managing type 2 diabetes mellitus. It integrates two active compounds: pioglitazone, a thiazolidinedione, and metformin, a biguanide. The extended-release (XR) formulation aims to optimize glycemic control while minimizing gastrointestinal side effects associated with immediate-release versions. The product’s market performance hinges on evolving healthcare policies, competitive landscape, patent status, and emerging clinical evidence.

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Market Overview and Demand Drivers

Prevalence of Type 2 Diabetes

Type 2 diabetes remains a global health crisis, with the International Diabetes Federation (IDF) reporting over 537 million affected individuals in 2021, expected to reach 643 million by 2030 (IDF, 2021). The chronic nature of the disease necessitates long-term medication, driving consistent demand for combination therapies like ACTOPLUS MET XR.

Patient-Centric Therapeutic Trends

Modern treatment paradigms favor fixed-dose combinations (FDCs), offering improved adherence, simplified regimens, and potential reduction in side effects. The XR formulation appeals to patient compliance by reducing dosing frequency and gastrointestinal discomfort, further bolstering market uptake.

Healthcare Policy and Reimbursement Landscape

In several regions, government initiatives and insurance reimbursement policies prioritize cost-effective, well-tolerated therapies. The availability of generic versions and biosimilars significantly influences pricing strategies and market access, particularly in emerging markets.

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Competitive Landscape and Market Share Dynamics

Key Competitors

• Existing combination therapies: Glucophage XR (metformin extended-release), Actoplus Met (immediate release).
• New entrants: Innovator drugs like Ozempic (semaglutide), Trulicity (dulaglutide), and SGLT2 inhibitors (e.g., Jardiance).
• Generics: Increased availability of generic pioglitazone and metformin reduces barriers to entry for biosimilar competitors.

Market Positioning of ACTOPLUS MET XR

ACTOPLUS MET XR benefits from the clinical perception of improved tolerability over immediate-release formulations, particularly in reducing gastrointestinal adverse effects. Its once-daily dosing aligns with current adherence optimization strategies, fostering sustained prescriber preference. However, competition from newer drug classes, especially GLP-1 receptor agonists and SGLT2 inhibitors, may limit its long-term dominance.

Patent and Regulatory Influences

Patent expiry timelines shape market exclusivity. In key markets, patent around ACTOPLUS MET XR is expected to lapse over the next 3-5 years, opening opportunities for generic manufacturers and biosimilar development, which could intensify price competition.

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Financial Trajectory and Revenue Projections

Historical Revenue Trends

While specific sales data for ACTOPLUS MET XR remains proprietary, market analysis suggests a steady growth pattern driven by rising diabetes prevalence and increasing adoption of extended-release combinations. In India, for example, the oral antidiabetic market size was valued at over USD 4 billion in 2020, with a CAGR of approximately 7%, reflecting increasing demand for combination therapies.

Forecasted Growth

• Short-term outlook (1-3 years): Anticipated modest growth, driven by geographic expansion in emerging markets and ongoing physician education about XR benefits.
• Medium to long-term (3-7 years): As patents expire, market penetration of generics may lead to increased volume sales but compressed margins. The entry of biosimilars and new combination formulations could diversify options, impacting overall revenue.

Pricing Strategies and Market Penetration

Pricing remains sensitive to regional healthcare policies and competitive pricing of generics. Companies leveraging patient-centric features and clinical benefits may maintain premium positioning. Direct-to-consumer advertising, where permissible, can bolster awareness and adoption rates.

Regulatory and Clinical Development Influences

Phase III clinical studies demonstrating superior efficacy or safety could support label expansions, thereby increasing market potential. Conversely, safety concerns or regulatory rejections could impede revenue growth.

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Emerging Trends and Future Outlook

Pharmacogenomics and Personalized Medicine

As precision medicine advances, tailoring therapy based on genetic profiles may influence prescribing patterns, potentially affecting the market share of fixed-dose combinations like ACTOPLUS MET XR.

Digital Healthcare Integration

The adoption of digital health tools, including adherence monitoring apps, can enhance treatment compliance, thereby positively influencing sales trajectory. Pharmaceutical companies investing in such strategies are better positioned for sustained growth.

Global Market Penetration

Emerging markets account for a significant share of new diabetes cases and represent growth hotspots. Strategic partnerships with local distributors and adaptation to regional pricing policies will be crucial.

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Regulatory and Patent Outlook

The lifecycle of ACTOPLUS MET XR is significantly influenced by patent protections and regulatory clearances. Pending patent expirations open avenues for generic formulations, which tend to capture substantial market share due to cost advantages. Regulatory uncertainties, especially in different jurisdictions, can impact market entry timing and revenue flow.

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Conclusion

The market dynamics for ACTOPLUS MET XR are shaped by rising diabetes prevalence, evolving treatment guidelines favoring combination therapies, and an increasingly competitive landscape. Its financial trajectory depends on patent protection timelines, regional acceptance, clinical positioning, and directional shifts towards newer drug classes. While current momentum suggests steady growth, the impending patent expiries and technological trends signal impending challenges and opportunities.

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Key Takeaways

• Growing demand for combination, extended-release antidiabetic therapies sustains long-term market opportunity for ACTOPLUS MET XR.
• Patent expirations within the next 3-5 years are likely to introduce generics, intensifying pricing competition and compressing profit margins.
• Clinical positioning emphasizing improved tolerability and adherence advantages supports market retention amid competition.
• Emerging therapies like SGLT2 inhibitors and GLP-1 receptor agonists are poised to influence prescribing trends toward newer alternatives.
• Market expansion in emerging economies remains critical, driven by increasing diabetes prevalence and healthcare infrastructure improvements.

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FAQs

1. What factors primarily influence the market growth of ACTOPLUS MET XR?
Market growth hinges on rising diabetes prevalence, patient adherence advantages offered by XR formulations, competitive pricing, and regional healthcare policies promoting combination therapies.

2. How will patent expiration affect ACTOPLUS MET XR's market position?
Patent expirations will facilitate generic entry, leading to lower prices, increased access, and potential revenue decline for the original branded product unless differentiated by clinical data or formulation advantages.

3. Are newer drug classes threatening ACTOPLUS MET XR’s market share?
Yes. Agents like SGLT2 inhibitors and GLP-1 receptor agonists are increasingly favored due to additional cardiovascular benefits, potentially reducing demand for traditional oral combinations.

4. Can clinical evidence bolster ACTOPLUS MET XR’s long-term competitiveness?
Absolutely. Demonstrated superior safety, efficacy, or patient outcomes can reinforce its position, especially if supported by real-world evidence and guidelines.

5. Which regional markets are most promising for the expansion of ACTOPLUS MET XR?
Emerging markets with high diabetes burdens—such as India, Southeast Asia, and Latin America—offer significant growth opportunities, contingent on affordability and regulatory approval.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 2021.
[2] Market research reports on global diabetes therapeutics, 2022.
[3] Regulatory updates and patent expiry schedules from major pharmaceutical authorities.