Viewing data from:

ACTOPLUS MET

NDA

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | N021842 | TAKEDA PHARMACEUTICALS USA INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (1)Active (1)Today

2027

2028

2029

Today

9101660

Jan. 22, 2027

9320714

Feb. 3, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Takeda Pharmaceutical Company Limited et al v. Aurobindo Pharma Limited et al 1:2010cv01339 3 patentsANDA 20823pioglitazone hydrochloride and metformin hydrochloride	S.D.N.Y.	2010-02-18	Terminated 2010-05-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Actoplus Met (2023)

Total Spending

$131K

Total Claims

143

Beneficiaries

Avg Cost/Unit

$10.23

Spending Trend

$374K(2019)→$312K(2020)→$204K(2021)→$141K(2022)→$131K(2023)

YoY Change:-0.5%

5yr CAGR:+1.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -22	View Letter (PDF)
Dec 14, 2016	SUPPL -21	View Letter (PDF)
Dec 13, 2016	SUPPL -20	View Letter (PDF)
Aug 19, 2014	SUPPL -19	View Letter (PDF)
May 22, 2012	SUPPL -16	View Letter (PDF)
May 18, 2012	SUPPL -8	View Letter (PDF)
May 18, 2012	SUPPL -10	View Letter (PDF)
Aug 4, 2011	SUPPL -14	View Letter (PDF)
Aug 4, 2011	SUPPL -15	View Letter (PDF)
Aug 11, 2010	SUPPL -12	View Letter (PDF)
Nov 25, 2009	SUPPL -11	View Letter (PDF)
Oct 26, 2009	SUPPL -9	View Letter (PDF)
Jan 6, 2009	SUPPL -7	View Letter (PDF)
Oct 4, 2007	SUPPL -5	View Letter (PDF)
Nov 7, 2006	SUPPL -2	View Letter (PDF)
Oct 2, 2006	SUPPL -3	View Letter (PDF)
Sep 18, 2006	SUPPL -1	View Letter (PDF)
Aug 31, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 29, 2005

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9101660	Jan 22, 2027	—	—	Yes	—	—
9320714	Feb 3, 2029	—	—	Yes	—	—

#002 — 850MG;EQ 15MG BASE

RLDAB

2 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 29, 2005