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ACTOPLUS MET Drug Patent Profile

When do Actoplus Met patents expire, and what generic alternatives are available?

Actoplus Met is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are four patents protecting this drug.

This drug has forty-one patent family members in twenty-five countries.

The generic ingredient in ACTOPLUS MET 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

Indicators of Generic Entry

Summary for ACTOPLUS MET

International Patents:	41
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	36
Drug Prices:	Drug price information for ACTOPLUS MET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOPLUS MET
What excipients (inactive ingredients) are in ACTOPLUS MET?	ACTOPLUS MET excipients list
DailyMed Link:	ACTOPLUS MET at DailyMed

See drug prices for ACTOPLUS MET

Recent Clinical Trials for ACTOPLUS MET

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 clinical trials

Pharmacology for ACTOPLUS MET

Drug Class	Biguanide 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 ACTOPLUS MET

ACTOPLUS MET 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	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		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	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes			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	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		DISCN	Yes	No			Y

Expired US Patents for ACTOPLUS MET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005

International Patents for ACTOPLUS MET

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

Country	Patent Number	Title	Estimated Expiration
Germany	10199018
Austria	438397
South Korea	20070119095	SOLID PREPARATION
Luxembourg	91606
Slovakia	287287

Supplementary Protection Certificates for ACTOPLUS MET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135	CA 2009 00045	Denmark
1506211	42/2014	Austria		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1532149	92128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
1412357	SPC/GB08/040	United Kingdom		PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
2498758	CR 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113

ACTOPLUS MET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACTOPLUS MET

Introduction

ACTOPLUS MET, a combination drug containing pioglitazone and metformin, is used to manage type 2 diabetes. This article delves into the market dynamics and financial trajectory of this medication, highlighting its launch, market performance, generic competition, and the impact of legal and regulatory factors.

Drug Composition and Mechanism

ACTOPLUS MET combines two antihyperglycemic agents: pioglitazone, an insulin-sensitizing agent, and metformin, which decreases hepatic glucose production. This combination improves glycemic control in patients with type 2 diabetes by enhancing peripheral glucose utilization and reducing insulin resistance[1].

Market Launch and Initial Performance

ACTOPLUS MET was marketed by Takeda Pharmaceuticals U.S.A., Inc. and was used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 diabetes. The drug saw significant sales, with annual revenues of approximately $413 million in the United States as of June 30, 2012[2].

Generic Competition

The market dynamics for ACTOPLUS MET were significantly impacted by the introduction of generic versions. Takeda settled patent litigation with several generic manufacturers, including Mylan, Sandoz, Ranbaxy, Torrent, Watson, Aurobindo, Wockhardt, and Teva. These settlements allowed generic versions to enter the market starting December 14, 2012, or earlier under certain circumstances. Teva, in particular, launched an authorized generic version of ACTOPLUS MET on August 17, 2012[4].

Financial Impact of Generic Competition

The entry of generic competitors led to a decline in Takeda's revenue from ACTOPLUS MET. Generic competition is a significant factor in the pharmaceutical industry, often leading to substantial reductions in sales for branded drugs. For instance, the launch of generic versions of ACTOPLUS MET and other Takeda products like ACTOS (pioglitazone) was anticipated to affect Takeda's financial forecasts, as outlined in their Mid-Range Plan announced in May 2010[4].

Legal and Regulatory Factors

Takeda faced significant legal challenges related to ACTOS, the primary component of ACTOPLUS MET. The company agreed to settle a large number of product liability lawsuits related to ACTOS, taking a $2.7 billion charge against earnings in the fourth quarter of fiscal year 2014. This settlement aimed to resolve the majority of pending lawsuits and reduce financial uncertainties for the company[5].

Market Sales and Revenue

The sales of ACTOPLUS MET were substantial before the entry of generic competitors. The drug generated annual sales of $413 million in the United States alone. However, with the introduction of generics, the revenue from ACTOPLUS MET declined significantly. This is a common trend in the pharmaceutical industry, where branded drugs experience a sharp decline in sales once generic equivalents become available[2].

Impact on Takeda's Financial Strategy

Takeda's financial strategy had to adapt to the changing market dynamics. The company's forecasts and financial plans were adjusted to account for the expected decline in sales due to generic competition. Despite these challenges, Takeda continued to focus on developing innovative medicines and managing its financial resources efficiently[4].

Competitive Landscape

The competitive landscape for type 2 diabetes treatments is highly dynamic, with multiple drugs and combinations available. ACTOPLUS MET faced competition not only from generic versions but also from other branded and generic antidiabetic medications. This competition necessitated continuous innovation and strategic planning by Takeda to maintain market share[2].

Conclusion

The market dynamics and financial trajectory of ACTOPLUS MET are characterized by strong initial sales, significant impact from generic competition, and legal challenges. Here are the key points:

• Strong Initial Sales: ACTOPLUS MET generated substantial revenue before the entry of generic competitors.
• Generic Competition: The introduction of generic versions led to a decline in sales and revenue.
• Legal Challenges: Takeda faced and settled product liability lawsuits related to ACTOS, affecting their financials.
• Adaptive Financial Strategy: Takeda adjusted its financial forecasts and strategies to manage the impact of generic competition.

Key Takeaways

• ACTOPLUS MET is a combination drug used to manage type 2 diabetes.
• The drug saw significant sales before generic competition.
• Generic versions significantly impacted revenue.
• Legal challenges related to ACTOS affected Takeda's financials.
• Takeda adapted its financial strategy to manage these changes.

FAQs

Q: What are the active ingredients in ACTOPLUS MET? A: ACTOPLUS MET contains pioglitazone and metformin hydrochloride.

Q: How does ACTOPLUS MET work? A: It combines an insulin-sensitizing agent (pioglitazone) and a drug that decreases hepatic glucose production (metformin) to improve glycemic control.

Q: What was the annual sales revenue of ACTOPLUS MET before generic competition? A: Approximately $413 million in the United States as of June 30, 2012.

Q: When did generic versions of ACTOPLUS MET enter the market? A: Generic versions entered the market starting December 14, 2012, or earlier under certain circumstances.

Q: How did Takeda manage the financial impact of generic competition and legal challenges? A: Takeda adjusted its financial forecasts, settled product liability lawsuits, and focused on developing innovative medicines.

Sources

1. ACTOPLUS MET Label - FDA.
2. Teva Announces Launch of Generic ACTOplus met - Teva Pharmaceutical Industries Ltd.
3. GSK Annual Report 2008 - GlaxoSmithKline.
4. Takeda Completes Settlements With All Defendants in U.S. Patent Litigation - Takeda Pharmaceutical Company Limited.
5. Takeda Agrees to Settle ACTOS Product Liability Lawsuits and Claims - Takeda Pharmaceutical Company Limited.