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. Five 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 four 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:	36
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			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		DISCN	Yes	No			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No			Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No			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
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009

International Patents for ACTOPLUS MET XR

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

Country	Patent Number	Title	Estimated Expiration
Canada	1277323	DERIVES DE THIAZOLIDINEDIONE, LEUR PRODUCTION ET LEUR EMPLOI (THIAZOLIDINEDIONE DERIVATIVES, THEIR PRODUCTION AND USE)
China	1289082
Japan	S61267580	THIAZOLIDINE DERIVATIVE
Japan	H0967271	MEDICINE
World Intellectual Property Organization (WIPO)	2005107750
World Intellectual Property Organization (WIPO)	2006044077

Supplementary Protection Certificates for ACTOPLUS MET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
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	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126
1506211	SPC/GB14/050	United Kingdom		PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121

Market Dynamics and Financial Trajectory for ACTOPLUS MET XR

Introduction

ACTOPLUS MET XR is a combination medication containing pioglitazone and extended-release metformin, used to manage type 2 diabetes. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Mechanism of Action and Clinical Use

ACTOPLUS MET XR combines two antihyperglycemic agents: pioglitazone, a thiazolidinedione, and metformin, a biguanide. Pioglitazone enhances peripheral glucose utilization and decreases hepatic glucose output, while metformin reduces endogenous hepatic glucose production. This combination is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes[2][4].

Market Indicators

Demand and Patient Base

The demand for ACTOPLUS MET XR is driven by the growing prevalence of type 2 diabetes globally. As the population ages and obesity rates increase, the need for effective antidiabetic medications rises. The medication is particularly useful for patients who are not adequately controlled on metformin monotherapy or other antidiabetic agents.

Competitive Landscape

The antidiabetic market is highly competitive, with various classes of medications available, including sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. ACTOPLUS MET XR competes with other combination therapies and single-agent treatments. However, its unique combination of pioglitazone and extended-release metformin provides a distinct advantage in terms of glycemic control and patient compliance[4].

Financial Performance

Sales and Revenue

Historically, the sales of ACTOPLUS MET and its variants have been significant, although they have faced challenges due to generic competition and safety concerns associated with pioglitazone. For example, in 2008, GlaxoSmithKline (GSK), which has been involved in the distribution and development of similar antidiabetic medications, reported a decline in pharmaceutical turnover partly due to generic competition and lower sales of Avandia (another pioglitazone-containing drug)[3].

Impact of Generic Competition

The expiration of patents for key antidiabetic medications, including pioglitazone, has led to the entry of generic competitors. This has reduced the market share and revenue of branded products like ACTOPLUS MET XR. However, the extended-release formulation of metformin in ACTOPLUS MET XR may offer some protection against generic erosion due to its unique delivery mechanism.

Safety and Regulatory Considerations

Heart Failure and Renal Impairment

ACTOPLUS MET XR is associated with significant safety concerns, including the risk of heart failure and renal impairment. Patients with established New York Heart Association (NYHA) Class III or IV heart failure are contraindicated from using this medication. Additionally, it is not recommended for patients with severe renal impairment (eGFR below 30 mL/min/1.73 m^2)[2][4].

Lactic Acidosis and Hepatic Effects

The medication also carries risks of lactic acidosis and hepatic failure, which can be fatal. These safety concerns necessitate careful patient selection and monitoring, potentially affecting its market adoption and financial performance[2][4].

Clinical Trials and Efficacy

Efficacy in Clinical Studies

Clinical trials have demonstrated the efficacy of ACTOPLUS MET XR in improving glycemic control in patients with type 2 diabetes. Studies have shown that the combination of pioglitazone and metformin provides an added benefit over metformin monotherapy, supporting its use in clinical practice[4].

Pricing and Access

Cost Considerations

The pricing of ACTOPLUS MET XR is a critical factor in its market dynamics. The medication is generally more expensive than some of its competitors, which can affect patient access and adherence. However, its once-daily dosing and the convenience of a single tablet may justify the cost for some patients.

Insurance Coverage and Reimbursement

Insurance coverage and reimbursement policies also play a significant role in the financial trajectory of ACTOPLUS MET XR. Variations in coverage across different regions and healthcare systems can impact sales and revenue.

Future Outlook

Market Trends

The antidiabetic market is expected to grow due to increasing diabetes prevalence. However, ACTOPLUS MET XR will need to navigate the challenges of generic competition, safety concerns, and evolving treatment guidelines.

Strategic Initiatives

Pharmaceutical companies may focus on strategic initiatives such as improving patient compliance, enhancing safety profiles through additional studies, and expanding into emerging markets to maintain and grow the market share of ACTOPLUS MET XR.

Key Takeaways

• Combination Therapy: ACTOPLUS MET XR offers a unique combination of pioglitazone and extended-release metformin, enhancing glycemic control.
• Safety Concerns: The medication is associated with heart failure, renal impairment, lactic acidosis, and hepatic effects, requiring careful patient monitoring.
• Market Competition: The antidiabetic market is highly competitive, with generic competition and new classes of medications emerging.
• Financial Performance: Sales have been impacted by generic competition and safety concerns, but the medication remains a significant player in the market.
• Future Outlook: The market is expected to grow, but the medication must navigate ongoing challenges to maintain its position.

Frequently Asked Questions (FAQs)

1. What are the primary components of ACTOPLUS MET XR?

ACTOPLUS MET XR contains pioglitazone, a thiazolidinedione, and extended-release metformin, a biguanide.

2. What are the main indications for ACTOPLUS MET XR?

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

3. What are the significant safety concerns associated with ACTOPLUS MET XR?

The medication is associated with heart failure, renal impairment, lactic acidosis, and hepatic effects.

4. How does ACTOPLUS MET XR compare to other antidiabetic medications?

It offers a unique combination of pioglitazone and extended-release metformin, providing an added benefit over metformin monotherapy and other single-agent treatments.

5. What is the impact of generic competition on ACTOPLUS MET XR?

Generic competition has reduced the market share and revenue of ACTOPLUS MET XR, although the extended-release formulation of metformin may offer some protection.

Cited Sources:

1. Takeda Pharmaceuticals: ACTOPLUS MET XR Prescribing Information.
2. DailyMed: ACTOPLUS MET- pioglitazone and metformin hydrochloride tablet.
3. GSK Annual Report 2008: Financial and Strategic Overview.
4. FDA Label: ACTOPLUS MET - pioglitazone and metformin hydrochloride tablet.