Is there a generic for Metformin hydrochloride; pioglitazone hydrochloride?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Metformin hydrochloride; pioglitazone hydrochloride, referencing the brand ACTOPLUS MET XR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Metformin hydrochloride; pioglitazone hydrochloride?

ACTOPLUS MET XR (NDA 022024, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Metformin hydrochloride; pioglitazone hydrochloride?

The Orange Book lists 4 patents against Metformin hydrochloride; pioglitazone hydrochloride products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

FDA Orange Book · active-ingredient family

Metformin hydrochloride; pioglitazone hydrochloride

Metformin hydrochloride; pioglitazone hydrochloride: 2 brands, 6 generics; first approved Aug 29, 2005; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 6 ANDA applications approved.

Earliest patent expiry Jul 31, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 31, 2026

in 20 d

Originator applications

Brand (NDA) products

ACTOPLUS MET XRRLD

TAKEDA PHARMS USANDA 02202420092 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM;EQ 15MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
1GM;EQ 30MG BASE	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

ACTOPLUS METRLD

TAKEDA PHARMS USANDA 02184220052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
850MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (6)

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

MACLEODS PHARMS LTDANDA 20480220152 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB
850MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

TEVA PHARMS USAANDA 09115520142 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB
850MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

CHARTWELL RXANDA 09127320132 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE	TABLET	ORAL	Discontinued	—
850MG;EQ 15MG BASE	TABLET	ORAL	Discontinued	—

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 20082320132 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB
850MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

TORRENT PHARMS LTDANDA 20200120132 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB
850MG;EQ 15MG BASE	TABLET	ORAL	Rx	AB

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

PHARMOBEDIENTANDA 09040620112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG;EQ 15MG BASE	TABLET	ORAL	Discontinued	—
850MG;EQ 15MG BASE	TABLET	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7959946	Jul 31, 2026	in 20 d	Product
7785627	Jul 31, 2026	in 20 d	Product
9101660	Jan 22, 2027	in 7 mo	Product
9320714	Feb 03, 2029	in 2 yr 7 mo	Product

FDA approval span

Approval history

First approval

Aug 29, 2005

21 yr 2 mo ago

Most recent approval

Nov 05, 2015

10 yr 10 mo ago

Approvals span 2005–2015 across 8 FDA applications.

Brand (NDA) 225%

Generic (ANDA) 675%